The Pelvic (floor) Reminders (to) Explore Perinatal (women’s) Acceptability (of) Reminders (to) Exercise (PREPARE) study: protocol for a feasibility trial

doi:10.21203/rs.3.rs-3879015/v1

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Research Article

The Pelvic (floor) Reminders (to) Explore Perinatal (women’s) Acceptability (of) Reminders (to) Exercise (PREPARE) study: protocol for a feasibility trial

https://doi.org/10.21203/rs.3.rs-3879015/v1

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Background

Pelvic Floor Muscle Dysfunction (PFMD) is a condition that affects up to one in three women at some point in their lifetime and can typically be traced back to the perinatal period. Supervised Pelvic Floor Muscle Training (PFMT) is the gold standard of treatment for symptoms of PFMD however women commonly forget to complete PFMT. ‘Nudges’ are a behavioural intervention that can be targeted to certain populations and can be integrated in existing reminder features in mobile apps. No study has tested this novel digital intervention to encourage perinatal women to complete PFMT. The overall aim of this feasibility trial is to explore adherence to PFMT in those who receive targeted digital nudges and a mobile app compared to those who receive a leaflet.

Methods

A feasibility study will explore acceptability of digital PFMT nudges amongst perinatal women. Seventy-five women over 26 weeks pregnant will be invited to participate in the study. Women who consent to participating will be randomised to either the intervention or control group. Those in the intervention group will receive a weekly digital PFMT nudge and a PFMT mobile app until they are four months postnatal. Those in the control group will receive a PFMT leaflet. Participants will have three follow-ups at 9, 21 and 31 weeks corresponding to the appropriate gestational and post-natal phase. Both quantitative and qualitative data will be collected. Quantitative data will be collected at each follow up and will include the EQ5D5L, ICIQ-UI SF, EARS, the Broome Pelvic Muscle Self-Efficacy Scale, self-recorded PFMT adherence logs as well as in-app adherence. Qualitative data will be collected through interviews of between five to ten participants at the end of the study. One open-ended question on the acceptability of the intervention at each follow up will be asked.

Discussion

This feasibility trial will attempt to better understand perinatal women’s acceptability of the novel intervention and study processes provide practical and relevant solutions that can be taken forward in a randomised controlled trial.

Pelvic Floor Muscle Training

Nudging

Mobile App

Adherence

Pelvic Floor Muscle Dysfunction (PFMD) is a condition that affects up to one in three women at some point in their lifetime and can be commonly traced back to the perinatal period due to the physiological changes associated with pregnancy and childbirth [1, 2]. The most prevalent symptom of PFMD is Stress Urinary Incontinence (SUI), defined as the “complaint of involuntary loss of urine on effort or physical exertion (e.g., sporting activities), or on sneezing or coughing” [3]. The social, emotional, economic, and environmental impact of SUI is well documented and includes social isolation, difficulty returning to work, impaired sexual function and prevention of vigorous exercise [4]. The predicted cost of urinary incontinence to the UK NHS is up to £117 million a year [5] with single use sanitary products taking up space in landfill.

Supervised Pelvic Floor Muscle Training (PFMT) is the gold standard of treatment for symptoms of SUI [1]. Pelvic floor muscle training is defined as ‘exercise to improve pelvic floor muscle strength, endurance, power, relaxation or a combination of these parameters’ [6]. A Cochrane review of the evidence found that in prevention trials, women were 29% less likely to develop UI during pregnancy or in the early post-natal period [7]. The National Institute of Clinical Excellence [1] recommends that women complete supervised PFMT three times a day for a minimum of three months for it to be effective at reducing symptoms of PFMD; however, clinically, it is recognised women do not regularly adhere to this exercise prescription.

In the wake of the NHS Long Term (LT) Plan [8] NHS England has rolled out new perinatal pelvic health services in the UK with the aim of ‘ensuring understanding, adoption and adherence by women to PFMT’ [9] however meeting these national requirements are a challenge. Specialist pelvic health physiotherapists are recognised practitioners who can support women in PMFT however the demand for the service far outweighs staff capacity. Further, staff shortages in midwifery have been at a high since the end of the COVID-19 pandemic meaning the capacity for regular supervision with specialist staff is low. Supervision from a healthcare professional is one of several behavioural techniques used to facilitate behaviour change in women around PFMT [10].

The Capability Opportunity and Motivation Behavioural Change Framework (COM-BCW) is a theoretical framework used to design interventions to encourage individual behaviour change [10, 11]. The framework states that an individual’s capability, opportunity, and motivation to complete a behaviour are crucial to changing it. Nudge theory is one of the 19 theories underpinning the COM-BCW [12]. Nudge theory considers ‘environmental cues’ that influence individual decision-making, e.g. the height of food in the supermarket. These cues or reminders are recognised in the behavioural change taxonomy [13]. ‘Nudges’ are specifically designed based on the target population [14]. To date the effect of nudging on PFMT exercise adherence in a population of women has not been explored.

Health apps commonly use reminders for long-term conditions to promote self-management and have been proven effective in conditions such as diabetes [15] and participation in physical activity [16, 17]. The use of digital technology, such as mobile apps, in maternity care can personalise the treatment individual women receive thus improving healthcare delivery and in particular the management of PFMD [18]. It is hypothesised that personalisation of PFMT can be enhanced by providing ‘nudges’ as reminders and encouragement to enhance adherence to exercises.

Aim

The overall aim of this feasibility trial is to explore adherence to PFMT in those who receive targeted digital nudges compared to those who receive a leaflet. A feasibility study will determine whether the methodology and the intervention are acceptable amongst perinatal women in preparation for a future Randomised Controlled Trial (RCT).

Inclusion and exclusion criteria

Participants will be recruited from University Hospitals Dorset NHS trust. Participants will be pregnant women accessing NHS maternity care services. All participants will be primiparous women over the age of 18 who have a viable pregnancy. Pregnant women will be recruited following a routine anomaly scan at 20 weeks of pregnancy. PFMT will commence after 26 weeks in line with National Institute of Clinical Excellence (NICE) guidelines [1]. Women will not be included if they do not have a viable pregnancy.

The eligibility criteria includes primiparous women over the age of 18 who have a viable pregnancy and the ability to send and receive e-mail.

Participants will not be eligible if they are under the age of 18 or have haematuria, difficulty passing urine or bladder emptying difficulties, present malignancy of the pelvic area, a neurological disease that affects the urinary system, pyelonephritis, severe comorbidities in pregnancy (including placenta previa, threatened premature labour, pregnancy induced hypertension), hyperactivity of the pelvic floor, active urinary tract infection, history of stroke, diabetes or gestational diabetes, use of another PFMT mobile app, if they cannot read or understand written English. Only women who understand written English will be able to participate.

Study Design

This is a feasibility study of future RCT. The qualitative components of the study aim to add depth to the quantitative components around participant acceptability of:

The digital nudges

The design of the study

Study objectives

The overall aim will be determined using the following objectives:

Phase I

Recruitment and uptake: the ease with which perinatal women are recruited

Eligibility rate, including the proportion of volunteers screened that are eligible for inclusion

Consent rate: the proportion of those eligible that consent to the trial

Randomisation: participant acceptability of being randomised for future trial

Follow-up rate: the proportion of participants who attend follow-up appointments at one- two- and four- months

Data completion rate: the proportion of participants who complete questionnaires at one- two- and four- months

Participant adherence rates with pelvic floor muscle training

Participant acceptability of digital nudges

A traffic light system will be used decide if progression to a RCT is appropriate [19]. The criteria of progression has been adapted from Pitt et al.’s study [20] and justified using additional sources [21, 22]. A green rating will mean the study can progress to a RCT with none or minor amendments, an amber rating will highlight major amendments to progress to a RCT and a red rating will indicate the study should not progress.

Table 1

The progression criteria from feasibility to RCT
Progression criteria	Measurement	Green	Amber	Red
Phase I
Recruitment	Number of participants recruited within 3 months	30–40	19–29	< 19
Eligibility	Proportion of women screened as eligible	> 75% screened are eligible	Minor changes to eligibility criteria would increase the number to > 75%	Majority of those screened are ineligible or changes to the inclusion criteria required would prohibit meaningful results [19]
Initial consent	Proportion of women who consented to study	> 70%	50–69%	< 50% [19]
Acceptability of randomisation	Qualitative process evaluation	Most participants would be happy to be randomised for a future trial	Most would accept being randomised for interventions if there was an option to receive the intervention post RCT	Most participants would not accept being part of a control group in an RCT [19]
Follow up	Number of appointments attended by participants The number of re-arranged appointments	> 75% < 50%	50–75% 50–75%	< 50% > 75% [19]
Data completion	Follow-up questionnaires collected at one month, 2/12 and 4/12 perinatal	> 75% > 60%	50–75% 30–60%	< 50 < 30% [19]
Acceptability of intervention	Qualitative process evaluation	Most participants find the intervention acceptable or would request minor alterations	View on acceptability conflicting or major revisions needed	Most participants find the intervention unacceptable or changes required are not feasible [19]
Preliminary engagement rates	Number of participants who engage with a digital mobile app	5%	2–4%	0–2% [21]
Preliminary adherence rates	Number of participants who completed the PFMT in the Squeezy app within 3 months	> 40% completed PFMT once or more a day	15–40% completed PFMT weekly	< 15% completed PFMT sporadically or not at all [22]
Acceptability of the methodology for a future RCT	Qualitative process evaluation	Most participants accept being randomised for interventions in a future trial	Most participants accept being randomised for interventions if there was an option to receive the intervention after the study	Most participants would not accept being part of a control group in an RCT [19]

Intervention

The intervention consists of 31 targeted written PFMT ‘nudges’ e.g. “Have you done your pelvic floor exercises today?” The digital nudges were co-designed as part of a larger research study to support perinatal women to complete regular PFMT in line with National Standards [1, 6]. The total number of digital nudges is 31 to account for the number of weeks between 26 weeks of pregnancy and four-months postnatal.

The targeted nudges were designed following Patient and Public Involvement (PPI), a systematic scoping review of literature [23] around interventions used in PFMT mobile apps and qualitative research. The nudges target different stages of the perinatal period and have been divided into the following categories:

Late antenatal

Early postnatal

Late postnatal

More general nudges for a perinatal population have also been designed and will be used over the few weeks a women may deliver. The nudges are underpinned by the COM-B framework and the behaviour change taxonomy according to the Medical Research Councils guidance for developing complex interventions [24].

The nudges will be in the form of push notifications distributed by the Principal Investigator (PI). These push notifications will be distributed by the lead researcher from a research phone. A digital nudge will be sent once a week to each participant. The frequency of the nudge was determined through PPI. Women will receive the first digital nudge between 26–28 weeks of pregnancy soon after they have been enrolled in the study. The nudges will be distributed around 6pm each weekly for the duration of the study based on previous PPI. Each digital nudge is unique and the last digital nudge will be sent around four months post-natal [25].

The PFMT mobile app given to participants in the intervention group is also connected to remote monitoring software called Squeezy Connect™. The remote monitoring system records when women complete tailored PFMT with the in-app visual support. Additional mobile-app features include symptoms tracker, exercise plans, exercise records, information on the role of the pelvic floor and how to complete PFMT, and a visual training feature.

Immediately after enrolment the lead investigator will set participants up with the PFMT mobile-app face to face in at the researcher site. Participants will have the option to stop receiving the digital nudges at any point during the research study. Participants will remain included in the intervention group if they choose not to receive digital nudges. For participants who do not wish to use a mobile app will be provided with a leaflet and their reason documented. In the event of a miscarriage the intervention will be ceased.

Explicit details of the digital intervention will be reported using the Template for Intervention, Description and Replication (TIDierR) guidelines following the study [26].

Control group

The control group will receive a leaflet on the role of the pelvic floor and how to complete PFMT developed by a UK based professional network of clinical specialist physiotherapists [27] as this reflects usual care.

Follow up and data collection

Quantitative

Perinatal women will have three follow up telephone follow-up lasting no longer than 30 minutes. The timing of these follow ups will be at 9, 21 and 31 weeks. These follow-ups correspond to the late antenatal stage of gestation (36 weeks), around one-month postnatal and four-months postnatal [25]. During each follow-up, perinatal women will be asked questions from the following validated measures:

The EQ5D5L quality of life questionnaire [28]

The International Consultation of Incontinence Questionnaire of Urinary Incontinence– Short Form (ICIQ-UI SF) [29]

The Broome Pelvic Muscle Self-Efficacy Scale (PMSES) [30]

Exercise Adherence Rating Scale (EARS) [31]

The EQ5D5L is a quality-of-life measure that ‘excellent’ psychometric properties across many populations and conditions [28]. The ICIQ-UI SF is the most internationally use questionnaire to quantify the severity of urinary incontinence symptoms [29]. The Broome questionnaire was chosen to measure individual self-efficacy specifically to PFMT [30, 32]. Individual’s self-efficacy around PFMT is a key predictor of PFMT adherence [10, 30, 32]. The EARS questionnaire was chosen to measure adherence behaviour and has been used in other studies exploring perinatal women’s PFMT adherence [31] alongside the optional use of online and paper diaries.

Other quantitative outcome measures include:

In-app engagement with a mobile app [21]

In-app adherence logs [34]

In-app adherence logs have been shown to be a popular feature of diet apps [34] because they capture real-time feedback within the mobile app. Engagement with mobile apps is integral to the success of interventions [21, 33, 35] Engagements rates are captured automatically in the mobile app.

Qualitative

One open ended question

Participants will be contacted over the phone at the pre-agreed follow up times at pre-planned times in the perinatal period to collect quantitative survey data. An open-ended survey question that focus on the participants acceptability of the intervention and study processes will be asked to the participant by the lead researcher at every follow-up. Uncertainty on any of the answers will be clarified with the participant. The follow up phone call will last no longer than 30 minutes.

Interviews

One to one semi structured interviews of 5–10 participants will be conducted to evaluate participants views on the acceptability of the digital nudges and study processes at a time suitable for participants [36, 37]. The interviews will occur just after four months to evaluate participants acceptability of the digital intervention [38]. The interview will be conducted by the lead researcher and will last between 30–45 minutes [19]. The questions for the interview will be draw upon the Theoretical Domains Framework (TDF) [39] and qualitative methods literature [40]. The Patient Activation Measure (PAM) questionnaire aims to determine the extent to which participants take an active role in their own health and care and has a good evidence base behind its use in the NHS [41] The TDF has been used to identify determinants of adherence [39]. The interviews will be audio-recorded and transcribed verbatim.

Consent process

Full informed written consent will be obtained using a consent form (Appendix 1) prior to data collection and randomisation. Informed consent, data collection and randomisation will be completed by the PI. Potential participants who meet the eligibility criteria will be provided with an overview of the study and told they do not have to participate in the study using a Patient Information Sheet (PIS). Participants will be provided with a PIS two weeks prior to their first contact with the PI. Participants will be given a minimum of five days to read the PIS before going through the consent process. Individuals who meet the eligibility criteria will be e-mailed after expressing their interest and sharing their information with research midwife or e-mailing the PI directly. The PI will take each participant through the consent process. A cover letter will ask women for their permission for the lead researchers to obtain relevant information about their birth and socio-demographic characteristics from their maternity notes e.g. stage of pregnancy and estimated date of delivery. The following socio-demographic information will be collected to provide information on digital literacy and inclusion in the study:

Employment status
Education
Disability
Postcode

Consent will be gained at every follow-up.

Participants withdrawal

Participants will be made aware of their right to withdraw from the study at any point by clearly stating this on the consent form and participant information sheet. Participants will be informed that should they withdraw; their data may still be used in the final analysis. Participants who withdraw from the study will not be replaced.

Recruitment

NHS healthcare professionals including research midwives, midwives, specialist physiotherapists and sonographers will be encouraged to signpost pregnant patients to recruitment posters during clinic appointments and education groups. QR codes will also be available for scanning on the posters. Additional recruitment strategies include social media via the Dorset Maternity Voices Facebook page and posters in waiting room on Poole Hospital site. Those interested will be able to contact the lead researcher by e-mailing a password protected e-mail. For those who found out about the study via posters will then be e-mailed digital patient information sheets. Those still interested in being a part of the study after reading patient information sheets will be contacted via phone by the lead researcher to assess their eligibility for the study. Following this, informed consent will be gained from participants via digital consent forms completed by the participant.

Women for interview will be recruited using opportunistic sampling from the sample of women exposed to the intervention. Approximately 5–10 women [42] will be invited after the study to attend a one-to-one, semi-structured interviews. No more than 10 women will be asked to interview but more than five may be contacted to achieve data saturation [42].

Randomisation and blinding

Participants will be randomised between 26–28 weeks of pregnancy by assigning random numbers to each subject using permuted block randomisation in REDCap™ software by the PI. Participants will be randomised into one of two arms of the study: the intervention group or the control group. It was not possible to blind data collectors or participants in the study, however objective measures were captured to increase internal validity and reduce observer bias [43]. A schema of the trial (Fig. 1) and SPIRIT template for reporting feasibility trials (Fig. 2, Appendix 2) demonstrate the schedule of study events [44].

Data management

Participants will be pseudo-anonymised using a unique study identity code. This identity code will be used on all forms and study documents related to individual participants. Two copies of participants personal data will be encrypted and stored separately. One will be stored in a digital Investigator Site File that will only be accessible to the research team. The other on the Bournemouth University OneDrive that can only be accessed by members of the research team on university premises. An access control system will be put in place allowing authentications and authorisation to be easily managed within the research team.

Participant data will be stored on the EDGE cloud-based research management system in line with NHS standard operating procedures. This system is hosted on the NHS server with user-based permissions in place as granted by internal system administrators. Data will be stored on a password protected laptop that will be locked securely overnight at the hospital. Data collected at the research site will comply with local NHS policy and procedures. Data will be stored for 10 years in line with Bournemouth University Research data policy. Following the project the data will be deposited in a university data repository (BORDaR). For individuals in the intervention group, data will be retained by the mobile app company for a period of 7 years and anonymised data will be owned by the app company.

Data sharing with third parties will involve anonymised raw data and occur via OneDrive with IT advice and support. This data will be anonymous and participants will consent to this data sharing activity.

Setting of the study

The trial will take place at the University Hospitals Dorset NHS foundation trust in Dorset, United Kingdom. The first face-to-face session with the chief researcher will take place on the hospital site.

Study duration

The study will run for 9 months from the February 2024 to October 2024. Anticipated enrolment date is the 1st February 2024. The current recruitment status for the study is pending.

Outcome measures

Several outcome measures will be trialled in the study to determine whether the intervention can be taken forward for an RCT. The proposed RCT would explore whether a physiotherapy led digital intervention to support perinatal women with PFMT increases PFMT adherence to reduce the incidence and severity of urinary incontinence in late pregnancy and the early post-natal period. The focus of the feasibility study is on acceptability of the study processes and intervention.

Primary outcome measures

EQ5D5L [28]
ICIQUI-SF [29]
Broome PMSES [30]
EARS [31]
In-app engagement rates with the mobile app [21]
In-app adherence logs [34]

Secondary outcome measures

Interview data
One open ended question ‘which nudges best supported you in your training and why’

The EQ5D5L, ICIQ-UI SF, self-reported adherence and Broome questionnaires will be completed at the point of enrolment. These outcome measures and the EARS questionnaire will be used at every telephone follow-up with the PI. The questionnaire will be digital and input into an iPad during the study. Each online questionnaire will have a unique identifier code related to each participant. If a participant misses a scheduled telephone appointment, then a further telephone appointment will be arranged the next week. If the participant missed the second appointment, then the questionnaires will be sent through a hyperlink via e-mail. This will be captured as part of the evaluation of the design process in the trial. Primary and secondary data will be collected on the web-based platform REDCap™.

In-app engagement and adherence data will be captured throughout the study based on how the participants interacts with the digital app.

Semi-structured interviews will be conducted to evaluate participants’ acceptability of the intervention. Participants will specifically be asked about their knowledge of PFMT, their confidence and ability to perform PFMT, their beliefs around changing their symptoms with PFMT and whether the intervention encouraged them to complete PFMT. They will also be asked specific questions on their acceptability of the study design processes, specifically participants will be asked about whether the timing and frequency of the nudges were acceptable and whether they found randomisation acceptable. The interviews will take place either on Microsoft Teams or in person, depending on participant preference.

Table 3

The process of data collection
Outcome/ data	Timing of data capture	Process
Study processes	Following the first face to face contact and at every follow-up appointment	This includes the number of participants recruited at 3 months, the proportion of women screened as eligible, the proportion of women who consented, the number of women who were stuck with their initial randomised group, the number of follow-up appointments attended by women, the number of women who re-arranged follow-ups and the number of questionnaires completed
Participants engagement with digital PFMT nudges	Information on how participants interact with the mobile app. This will be captured by the mobile app throughout the study	Raw data be transferred from the third parties metabase to OneDrive weekly with IT support. This raw data will contain pseudo anonymised data of participant engagement rates in the intervention group
Adherence to pelvic floor muscle training	1. Adherence data captured by mobile app	PFMT adherence data will be captured with an in-app algorithm. The definition of in-app adherence is the number of women who start or complete a full set of PFMT using the visual in-app support program.
Participant views on the acceptability of the intervention	Virtual interview after the study	Participants will be opportunistically sampled to interview virtually to explore their acceptability of the digital nudges and study processes

Sample size and justification

We aim to recruit 74 considering a 20–33% drop out in similar studies [22, 29]. We aim to retain 60 participants during the trial for final data collection (30 participants in each group) [45]. This sample size has been chosen to address the aims of the study and address key design parameters for a future RCT. Recruiting 74 participants is approximately 1% of the population of 6259 lives births in Dorset per annum according to data from the Local Maternity and Neonatal System (LMNS) in Dorset. Participants will be recruited over a three-month period.

We aim to recruit 6–8 participants for interview. Participants will be contacted using their e-mail address provided.

To prevent underpowering of the main trial that aims to explore whether a physiotherapy led digital intervention to support perinatal women with PFMT increases PFMT adherence, a sample size of 30 was chosen. This is based on other studies supporting a sample size of 24–30 in each arm of the study is an appropriate size for a sample study [46–49].

Analysis

Statistical analysis

There will be a focus on descriptive analysis of the quantitative data and descriptive analysis performed using the calculation of the mean value, standard deviations, interquartile ranges and medians. The difference between the two calculated means will be determined. Data completion rate will be measured as part of the feasibility criteria for progression to RCT. Participants' numbers and characteristics will be summarised using descriptive statistics, completeness and data will be assessed. The IBM SPSS software 28 (Statistical Package for social scientists) will be used to analyse the quantitative data.

The NVivo software package will be used to code qualitative data. The qualitative data collected around the acceptability of the intervention and study processes. The data will be anonymised prior to being read several times by researcher number one. The lead researcher will go through the transcripts and identify codes before developing themes. The codes identified will lead to the development of themes. Themes will be agreed, and any disagreements will be discussed with a third reviewer.

Themes will be coded using descriptive statistics to enable comparison and integration the qualitative and quantitative data. The data will be merged during the interpretation phase. A traffic light system to identify whether each outcome has met the requirements for progression of this phase 1 trial to a definitive trial. A working analytical framework will be created and data will be input into the framework matrix.

Qualitative themes will be tabulated under the headings used in Table 1.

Patient and public involvement

Patient and Public Involvement (PPI) has been the integral to the co-design of the intervention and feasibility trial. To date PPI has focused on the key stages of intervention co-design according to the Experienced-based Co-design (EBCD) approach [50].

To influence the co-design of the intervention, PPI was conducted in the following ways:

On social media to determine if digital pelvic floor muscle training reminders was something female populations responded to positively

Via national surveys data captured locally which asked women accessing perinatal services how they wished to obtain information related to pelvic floor muscle training, which influenced the choice of intervention.

Via local maternity voices partnership groups on Facebook who were asked to provide feedback on how often they would like to be reminded to do pelvic floor muscle training. Finally, app developers were engaged to determine the language of the nudges they preferred and which nudge goes where.

Clinicians from the NHS were engaged in a workshop to facilitate the trial and gauge attitudes towards the choice of intervention in future practice. Future PPI will involve the patients when producing patient information for the study and dissemination of research findings in accessible public facing forums.

Adverse effects

No adverse events are anticipated in the research study. Any adverse events will be collected and reported. There is a small risk that digital PFMT nudges will be negatively received however this has been mitigated with PPI and careful co-design. Participants will be asked how they received digital nudges during pre-booked telephone follow ups throughout the study.

There are no known adverse effects associated with PFMT in pregnancy. NICE guidelines [1] recommend antenatal women begin PFMT from 20 weeks of pregnancy which is reflected in the study.

The purpose of the feasibility protocol is to outline the intended plan for exploration of adherence to PFMT in a population of perinatal women who received targeted digital PFMT nudges compared to those who received a leaflet. The proposed feasibility trial will determine whether the intervention and the methodology are acceptable. The outcomes of the study will determine whether the feasibility trial can progress to a future RCT. A traffic light system will be used determine if progression to a RCT is appropriate [19]. The traffic light system consider three key areas of the feasibility that will be evaluated: the intervention and the study processes.

Digital PFMT nudges are a novel means to supporting women in their PFMT using targeted reminders to encourage habit formation and behaviour change. As such, this feasibility study has been designed to determine whether this novel digital intervention is an acceptable from the perspective of perinatal women. The intervention’s content, mode of distribution, timing and frequency will be evaluated using semi-structure interviews.

This article demonstrates a methodology that will be adopted for the feasibility trial. To evaluate the methods chosen data on the number of participants recruited into the study, the eligibility rate, consent rates, follow up rates and data completion rates will be used to determine if this methodology is feasible to take forward as a randomised controlled trial.

Adherence is complex and multifaceted. This feasibility protocol uses a range of outcome measures, self- reported measures, and in-app analytics to gain a deeper insight into perinatal women’s adherence to PFMT. The influence of the intervention on perinatal women’s PFMT adherence will be captured through these quantitative outcome measures and in-app analytics. Determining whether the intervention influences perinatal women’s adherence to PFMT is important to determine before conducting a future RCT.

Based on similar studies the anticipated challenges of the feasibility study are recruitment and data completion. Recruitment of pregnant women has been as low at 20% in other studies [51]. To mitigate against low recruitment, sonographers will aid in the recruitment of women following their routine anomaly scan at 20 weeks. Recruitment campaigns will also be run on Dorset Maternity Matters Website, on posters in NHS waiting areas and via physiotherapy education groups in the NHS. To mitigate against low data adherence in the study, follow up will be conducted virtually in attempt to improve data collection and reflect normal practice following the COVID 19 pandemic.

Dissemination and outputs

The findings of the study will be presented at relevant conferences. The data will be deposited on the Bournemouth University repository (BORDaR). The findings will be published in open access peer reviewed journals. The results will also be shared at a future patient engagement event.

Limitations

Inaccuracy of predictions and assumptions made from the data collected in feasibility studies is a limitation. To mitigate this any predictions or assumptions will be discussed with the research team prior to any future RCT. Contamination of data is a limitation of feasibility studies, however the data from the feasibility trial will not be used in any future RCT. The Success of the feasibility trial does not mean success of the RCT, however the acceptability of key areas of study design is the main objective of the study which should optimise the potential success of any future RCT. The treatment effects cannot be determined from feasibility trials. Instead initial trends will be explored that may help justify future RCT.

PFMD

Pelvic Floor Muscle Dysfunction

SUI

Stress Urinary Incontinence

PFMT

Pelvic Floor Muscle Training

NHS

National Health Service

NICE

National Institute of Clinical Excellence

COM-BCW

Capability Opportunity Motivation Behaviour Change Wheel

RCT

Randomised Controlled Trial

PPI

Patient and Public Involvement

TIDieR

Template for Intervention Description and Replication

ICIQ-UI SF

The International Consultation of Incontinence Questionnaire of Urinary Incontinence– Short Form

TDF

Theoretical Domains Framework

PAM

Patient Activation Measure

PIS

Participant Information Sheet

Quick Response

REDcap™

Research Electronic Data Capture

BORDaR

Bournemouth Online Research Data Repository

LMNS

Local Maternity and Neonatal System

EBCD

Experienced-based Co-design

Ethics approval and consent to participate

This manuscript is based on Protocol version 2.0, dated 9th December 2023, approved by South Central Hampshire B Research Ethics Committee (14/SC/0160, approval date 12/01/2023). All important study modifications will be reported to the Health Research Authority (HRA). The study sponsor is Bournemouth University who are responsible for the management and design of the study. The study will be conducted at University Hospitals Dorset NHS Foundation Trust. The study will be conducted according to the principles of the Declaration of Helsinki and in accordance with other relevant national guidelines, regulations and acts. As this is a single-centre feasibility study a Data Monitoring Committee (DMC) is not needed.

Consent for publication

Not applicable.

Availability of data and materials

The datasets (both used and analysed) will be made available by the corresponding author on reasonable request and in accordance with consent and ethical approval.

Competing interests

No competing interests.

Funding

This work was supported by the National Institute for Health Research (NIHR) [Applied Research Collaboration (ARC) Wessex doctoral Award, in conjunction with Bournemouth University and University Hospitals Dorset]. The views expressed in this publication are those of the authors and not necessarily those of the National Institute for Health and Care Research or the Department of Health and Social Care. The role of Bournemouth University, as sponsor, includes the management and design of the research. University Hospitals Dorset NHS Foundation Trust are responsible for the conduct of research.

Authors’ contributions

RH, MA, SS, CS and CC developed the protocol.

Acknowledgements

Not applicable.

National Institure of Clinical Excellene (NICE). Pelvic flood dysfunction: prevention and non-surgical management. 2021. https://www.nice.org.uk/guidance/ng210. Accessed 09 May 2023.
Jelovsek JE, Chagin K, Gyhagen M, Hagen S, Wilson D, Kattan MW, et al. Predicting risk of pelvic floor disorders 12 and 20 years after delivery. Am J Obstet Gynecol. 2018;218(2):222. .e1-.e19.
Haylen BT, De Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodynamics: Official J Int Cont Soc. 2010;29(1):4–20.
Dumoulin C, Cacciari LP, Hay-Smith EJC. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane database of systematic reviews. 2018(10).
Chartered Society of Physiotherapy (CSP), The Royal Colleye of Midwives (RCM), The Pelvic Obstetric and Gynaecological Physiotherpay (POGP). RCM/CSP Joint statement on Pelvic Floor Muscle Exercises: Improving health outcomes for women following pregnancy and birth. 2020. https://rcmcsp-joint-statement-on-pelvic-floor-muscle-exercises_4.pdf. Accessed 24 August 2023.
Bo K, Frawley HC, Haylen BT, Abramov Y, Almeida FG, Berghmans B, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for the conservative and nonpharmacological management of female pelvic floor dysfunction. Int Urogynecol J. 2017;28:191–213.
Woodley SJ, Boyle R, Cody JD, Mørkved S, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database of Systematic Reviews. 2020(5).
National Health Service (NHS). The NHS Long Term Plan. 2019. . Accessed 24 August 2023.
NHS England. NHS pelvic health clinics to help tens of thousands of women across the country. 2021. https://www.england.nhs.uk/2021/06/nhs-pelvic-health-clinics-to-help-tens-of-thousands-women-across-the-country/. Accessed 24 August 2023.
Michie S, van Stralen MM, West R. The behaviour change wheel: A new method for characterising and designing behaviour change interventions. Implement Sci. 2011;6(1):42.
Michie S, Atkins L, West R. The behaviour change wheel: a guide to designing interventions. 1st ed. United Kingdom: Silverback; 2014.
Thaler R, Sunstein C, Nudge. Improving decisions about health, wealth and happiness. 2nd ed. Great Britian: Penguin Books; 2009.
Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, et al. The Behavior Change Technique Taxonomy (v1) of 93 Hierarchically Clustered Techniques: Building an International Consensus for the Reporting of Behavior Change Interventions. Ann Behav Med. 2013;46(1):81–95.
Halpern D, Gallagher R. Can 'nudging' change behaviour? Using 'behavioural insights' to improve program redesign. In: Wanna J, Lee HA, Yates S, editors. Managing Under Austerity, Delivering Under Pressure. Australia: Griffin Press; 2015. pp. 165–83.
Louch G, Dalkin S, Bodansky J, Conner M. An exploratory randomised controlled trial using short messaging service to facilitate insulin administration in young adults with type 1 diabetes. Psychol Health Med. 2013;18(2):166–74.
Yasmin F, Banu B, Zakir SM, Sauerborn R, Ali L, Souares A. Positive influence of short message service and voice call interventions on adherence and health outcomes in case of chronic disease care: a systematic review. BMC Med Inf Decis Mak. 2016;16:46.
Schwebel FJ, Larimer ME. Using text message reminders in health care services: A narrative literature review. Internet interventions. 2018;13:82–104.
NHS England. Three year delivery plan for maternity and neonatal services. 2023. NHS England » Three year delivery plan for maternity and neonatal services. Accessed 4 April 2023.
Campbell KG, Batt ME, Drummond A. A feasibility study of the physiotherapy management of urinary incontinence in athletic women: trial protocol for the POsITIve study. Pilot and Feasibility Studies. 2020;6(1):103.
Pitt K, Feder GS, Gregory A, Hawcroft C, Kessler D, Malpass A, et al. The coMforT study of a trauma-informed mindfulness intervention for women who have experienced domestic violence and abuse: a protocol for an intervention refinement and individually randomized parallel feasibility trial. Pilot and Feasibility Studies. 2020;6(1):33.
Bidargaddi N, Almirall D, Murphy S, Nahum-Shani I, Kovalcik M, Pituch T, et al. To Prompt or Not to Prompt? A Microrandomized Trial of Time-Varying Push Notifications to Increase Proximal Engagement With a Mobile Health App. JMIR Mhealth Uhealth. 2018;6(11):e10123.
Asklund I, Nyström E, Sjöström M, Umefjord G, Stenlund H, Samuelsson E. Mobile app for treatment of stress urinary incontinence: A randomized controlled trial. Neurourol Urodyn. 2017;36(5):1369–76.
Harper R, Sheppard S, Stewart C, Clark C. The role of pelvic floor muscle training mobile apps on pelvic floor muscle exercise adherence in women: a systematic review. PROSPERO: Int prospective register Syst reviews. 2022. https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022323789.
Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, et al. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021;374:n2061.
Rockliffe L, Peters S, Smith DM, Heal C, Heazell AEP. Investigating the utility of the COM-B and TM model to explain changes in eating behaviour during pregnancy: A longitudinal cohort study. Br J Health Psychol. 2022;27(3):1077–99.
Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348.
Pelvic Obstetric Gynaecological Physiotherapy. Pelvic Floor Muscle Exercises (for women). In: Pelvic Obstetric Gynaecological Physiotherapy booklets. 2021. Pelvic Floor Muscle Exercises (for women) | POGP (thepogp.co.uk). Accessed 24 August 2023.
Feng Y-S, Kohlmann T, Janssen MF, Buchholz I. Psychometric properties of the EQ-5D-5L: a systematic review of the literature. Qual Life Res. 2021;30(3):647–73.
Uren AD, Cotterill N, Pardoe M, Abrams P. The International Consultation on Incontinence Questionnaires (ICIQ): An update on status and direction. Neurourol Urodyn. 2020;39(6):1889–96.
Broome BA. Development and testing of a scale to measure self-efficacy for pelvic muscle exercises in women with urinary incontinence. Urol Nurs. 1999;19(4):258–68.
BickD, Bishop J, Coleman T, Dean S, Edwards E, Frawley H, Gkini E, Hay-Smith J, Hemming K, Jones E, Oborn E. Antenatal preventative pelvic floor muscle exercise intervention led by midwives to reduce postnatal urinary incontinence (APPEAL): protocol for a feasibility and pilot cluster randomised controlled trial. Pilot and Feasibility Studies. 2022;8(1):1–0.
Wang X, Xu X, Luo J, Chen Z, Feng S. Effect of app-based audio guidance pelvic floor muscle training on treatment of stress urinary incontinence in primiparas: a randomized controlled trial. Int J Nurs Stud. 2020;104:103527.
Freyne J, Yin J, Brindal E, Hendrie GA, Berkovsky S, Noakes M. Push notifications in diet apps: influencing engagement times and tasks. Int J Human–Computer Interact. 2017;33(10):833–45.
Hui CY, Walton R, McKinstry B, Jackson T, Parker R, Pinnock H. The use of mobile applications to support self-management for people with asthma: a systematic review of controlled studies to identify features associated with clinical effectiveness and adherence. J Am Med Inform Assoc. 2017;24(3):619–32.
Okoshi T, Tsubouchi K, Tokuda H. Real-world large-scale study on adaptive notification scheduling on smartphones. Pervasive Mob Comput. 2018;50:1–24.
Tashakkori T. SAGE handbook of Mixed Methods in Social & Behavioural Research. 2 ed. USA: SAGE Publications, Inc; 2010.
Creswell JW, Creswell JD. Research design: Qualitative, quantitative, and mixed methods approaches. 5th ed. USA: Sage Publications, Inc; 2018.
Acocella I, Cataldi S. Using Focus Groups: Theory, Methodology, Practice. 1st ed. London: SAGE Publications Ltd; 2021.
Lawton R, Heyhoe J, Louch G, Ingleson E, Glidewell L, Willis TA, et al. Using the Theoretical Domains Framework (TDF) to understand adherence to multiple evidence-based indicators in primary care: a qualitative study. Implement Sci. 2016;11(1):113.
Sayer P. Interviews in qualitative research. Mod Lang J. 2011;94(4):670–1.
Lightfoot CJ, Wilkinson TJ, Yates T, Davies MJ, Smith AC. Self-Management Intervention through Lifestyle Education for Kidney health’(the SMILE-K study): protocol for a single-blind longitudinal randomised controlled trial with nested pilot study. BMJ open. 2022;12(11):e064916.
Moser A, Korstjens I, Series. Practical guidance to qualitative research. Part 3: Sampling, data collection and analysis. Eur J Gen Pract. 2018;24(1):9–18.
Karanicolas PJ, Farrokhyar F, Bhandari M. Blinding: who, what, when, why. how? Can J Surg. 2010;53(5):345.
Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin J, Doré C, Parulekar W, Summerskill W, Groves T, Schulz K, Sox H, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 Statement: Defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–7.
Teare MD, Dimairo M, Shephard N, Hayman A, Whitehead A, Walters SJ. Sample size requirements to estimate key design parameters from external pilot randomised controlled trials: a simulation study. Trials. 2014;15(1):264.
Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004;10(2):307–12.
Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharm Statistics: J Appl Stat Pharm Ind. 2005;4(4):287–91.
Birkett MA, Day SJ. Internal pilot studies for estimating sample size. Stat Med. 1994;13(23–24):2455–63.
Wittes J, Brittain E. The role of internal pilot studies in increasing the efficiency of clinical trials. Stat Med. 1990;9(1–2):65–72.
Donetto S, Pierri P, Tsianakas V, Robert G. Experience-based co-design and healthcare improvement: realizing participatory design in the public sector. Des J. 2015;18(2):227–48.
Ali SH, Foreman J, Capasso A, Jones AM, Tozan Y, DiClemente RJ. Social media as a recruitment platform for a nationwide online survey of COVID-19 knowledge, beliefs, and practices in the United States: methodology and feasibility analysis. BMC Med Res Methodol. 2020;20(1):116.

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The Pelvic (floor) Reminders (to) Explore Perinatal (women’s) Acceptability (of) Reminders (to) Exercise (PREPARE) study: protocol for a feasibility trial

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Abstract

Background

Methods

Discussion

Figures

Background

Methods

Inclusion and exclusion criteria

Study objectives

Intervention

Control group

Follow up and data collection

Consent process

Participants withdrawal

Recruitment

Randomisation and blinding

Data management

Setting of the study

Study duration

Outcome measures

Statistical analysis

Patient and public involvement

Discussion

Abbreviations

Declarations

Ethics approval and consent to participate

Consent for publication

Availability of data and materials

Competing interests

Funding

Authors’ contributions

Acknowledgements

References

Status:

Version 1