Study design
The RCT study was conducted in China between February 2021 and March 2022 according to the amended Declaration of Helsinki. Participants who met the inclusion criteria were first contacted by visiting them in their room. Written and verbal consent was obtained from each participant (including their primary caregivers) after a full explanation of the research procedures. All participants could withdraw from this research at any time without adverse consequences. The research and procedures were approved by the ethical committee of the Third Affiliated Hospital of Soochow University (2021-CL002-01). The study was registered in the Chinese Clinical Trial Registry (http://www.chictr.org, ChiCTR2200056523). The CONSORT guidelines were followed during the course of the study.
Randomization
Participants were randomly assigned in equal proportions to the intervention (with an odd number) or control (with an even number) groups. The randomization sequence was generated by a statistician who does not know the content of this study through a computer-based randomizer (https://www.randomizer.org). Then, the printed sequence was loaded into an opaque envelope and passed to the recruitment team.
Participants
The participants (N = 82) were recruited from the spinal surgery department of a large general hospital in Changzhou. To be included in this research, participants must meet the following inclusion criteria: (1) aged between 18 and 65 years old; (2) SCI confirmed by magnetic resonance imaging (MRI), meeting the diagnostic criteria for NGB [16] and first admission; (3) American Spinal Injury Association (ASIA) Impairment Scale scores B, C, D; (4) injury level located in C5 ~ S5; (5) upper extremity (UE) motor scores [17] no less than grade 3; and (6) participants and their main caregivers have network equipment and are able to use it. Exclusion criteria included: (1) individuals with severe physical diseases; (2) abnormal urethral anatomy, urinary tract injury and serious urinary tract infection; (3) grievous urinary incontinence, bladder safety capacity less than 100 mL; and (4) cognitive, psychological and mental disorders.
Outcome measures
The demographic and disease-related questionnaire was designed based on a literature review to collect baseline data on participants at admission. Demographic information included age, sex, height, weight, educational experience, and marital status. Disease-related information included aetiologies of injury, levels of injury, and ASIA Impairment Scale score. All outcomes were measured by the same evaluator, who was blinded to participant group assignment. Except for patient self-efficacy (preintervention, 4 weeks postintervention, 8 weeks postintervention, 12 weeks postintervention), all other outcomes were measured at 12 weeks postintervention.
Primary outcomes
The primary outcomes were self-efficacy measured by the General Self-Efficacy Scale (GSES), self-management ability measured by the Self-Management Scale for Neurogenic Bladder Patients, and QOL measured by the MOS 36-Item Short Health Survey (SF-36).
The GSES includes 10 items rated on a 4-point Likert scale (1 = not at all true to 4 = exactly true), with total scores ranging from 1.0–4.0. The higher the score is, the higher the individual’s perceived self-efficacy. In our study, we selected the Chinese version (constructed by Zhang and Schwarzer) of the GSES (α = 0.91) [18]. Peter et al. used the Rasch analysis method to verify that the GSES is a reliable psychological measurement tool for persons with SCI [19].
The Self-Management Scale for Neurogenic Bladder Patients was developed by Chinese scholars Liu Yu et al. [20]. The 29-item scale consists of 3 dimensions, including knowledge (9 items), attitude (10 items) and behaviour (10 items). Each item of the knowledge dimension is scored on a 2-point scale (0 = no, 1 = yes). Each item of the attitude dimension is scored on a 5-point Likert scale (0.2 = strongly disagree to 1.0 = strongly agree). Each item of the behaviour dimension is scored on a 5-point Likert scale (0.2 = never to 1.0 = always). Reverse semantic items are reverse scored. The Cronbach's α coefficient and content validity index of the total scale were 0.725 and 0.900, respectively. A higher score reflects a higher self-management ability of neurogenic bladder persons.
The SF-36 [21] assesses 8 dimensions: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). The score for each subscale is the weighted sum of the items for that subscale, transformed into a 0-100 scale, where higher scores indicate better health and QOL [22]. Studies have shown that the SF-36 has is the most common tool for evaluating the objective QOL among persons with NGB after SCI [23].
Secondary outcomes
Secondary outcomes included the incidence of UTI, residual urine volume and bladder safety capacity.
The diagnostic criteria for UTI and bacteriuria were based on previous studies [24]. Incidence was defined as the number of UTI or bacteriuria cases in the population during the course of the study divided by the total number of people at risk of infection.
Residual urine volume was defined as the volume of urine remaining in the bladder after spontaneous voiding in persons with SCI. Residual urine volume was measured by urinary catheterization or B-mode ultrasonography.
Bladder safety capacity is defined as the maximum capacity within the bladder when the safety pressure does not exceed (≤ 40 cm H2O). Bladder safety capacity was measured by the modified bladder capacity measurement method.
Interventions
The duration of the intervention for each group of participants was 12 weeks from the time each subject agreed to participate in the study. The participants completed various examinations within one week after admission and then underwent surgery (decompression, internal fixation and fusion). The length of hospital (LOS) stay for each participant was generally controlled at approximately 1 month. All measures were performed by the same intervenor (different from the control group), who was blinded to participant group assignment.
Control group
The control group received routine standard admission and discharge education. After admission, the participants issued the guidance manual for bladder function training in persons with SCI (http://www.spinalcordessentials.ca), followed by routine education and guidance such as intermittent catheterization, drinking plan, voiding diary, common urinary system complications, bladder retraining, daily management knowledge of bladder dysfunction (including the treatment of urinary incontinence symptoms) and follow-up recommendations. The participants were followed up by telephone every 2 weeks after discharge and home visits were conducted at weeks 8 and 12 (rehabilitation assessment and continuous care support).
Intervention group
The intervention group received a self-efficacy-centred self-management program. The program was constructed based on two rounds of evidence-based and one round of expert meeting consultation. Based on the practical evidence of self-efficacy enhancement measures in patients with SCI (second round of evidence-based results) as a framework, combined with the practical evidence of rehabilitation management in persons with neurogenic bladder (first round of evidence-based results), the self-efficacy-centred self-management program of this study was preliminarily constructed. Finally, through expert meeting consultation, the preliminary intervention program of this study was improved. The self-efficacy-centred self-management program of this study included three phases.
Phase 1: Admission to preoperation
“One-to-one” bedside interview with participants and their primary caregivers. First, the treatment, nursing needs and psychological status of the participants were understood. Second, the knowledge of SCI related diseases and treatment, bladder training skills, prevention and nursing measures of secondary complications after other common SCI, and self-efficacy theory were introduced.
Participants and their primary caregivers watched videos showing better rehabilitation effects of persons with SCI to inspire participants’ confidence in rehabilitation treatment.
Participants and their primary caregivers received the content of voiding diaries and drinking plans, laying the foundation for the participant’s bladder training management in the next phase.
Help participants establish small goals for staged rehabilitation (goal setting); jointly establish rehabilitation action plans with participants (behaviour engagement); evaluate, feedback and supervise participants’ action plans (evaluation feedback).
Participants were encouraged to join the communication WeChat group of neurogenic bladder participants (wherein relevant rehabilitation nursing information was regularly communicated).
Phase 2: Postoperation to discharge
“One-to-one” bedside education course (multimedia) with participants and their primary caregivers. The course content includes the importance of rehabilitation nursing for persons with SCI, how to carry out rehabilitation training and nursing of bladder dysfunction, prevention and nursing of common complications of bladder training, and how to establish a reasonable rehabilitation attitude after SCI.
Daily guidance and supervision on the implementation of the participant’s voiding diary and drinking plan.
Guide participants and their primary caregivers to conduct clean intermittent catheterization training on urethral models (if necessary).
Instruct and supervise the participant’s daily behaviour training (timed voiding, delayed voiding, conscious voiding, etc.).
Three groups of participants, researchers and nursing staff (peer mentorship) were formed to form peer support. Nursing staff provided full rehabilitation guidance and support to participants. Researchers carried out quality control and evaluation, and timely feedback during this process.
Participants meeting before discharge. The meeting focused on how to manage negative emotions, how to accept life with symptoms, and special guidance for discharge.
Phase 3: Postdischarge guidance
Participants were followed up by telephone every 2 weeks after discharge and home visits were conducted at weeks 8 and 12.
Internet meeting. In weeks 7 and 11, participants were invited to watch a bladder self-management video through a conference software (Tencent Meeting).
Participants were encouraged to submit, on a biweekly basis, photo-based voiding diary and water drinking records and to respond promptly.
Sample size determination
The sample size was calculated using PASS 15 (NCSS, LLC., Kaysville, Utah, USA) and was guided by the estimates of minimal clinically important differences in self-efficacy in patients with SCI. The required minimal clinically important difference (2.9) and standard deviation (4.25) were determined by comprehensive analysis of data reported from relevant studies [25]. For the Tests for Two Means in a Repeated Measures Design procedure, with a power of 0.80, a significance level of 95%, a Rho of 0.65, and 4 Repeated Measurements, 25 subjects per group are needed. Given an expected a dropout rate of approximately 10% over the course of the trial, 3 additional subjects were assed to each group. Therefore, the total number of subjects required was 56. A total of 82 subjects participated in this research.
Statistical analysis
The data obtained were analysed using Statistical Package for Social Science 26.0 (IBM SPSS Inc., Armonk, NY, USA). Descriptive statistics, including frequencies, means, and standard deviations, were calculated for participant baseline characteristics. The Shapiro-Wilk test was performed to test the normality of continuous data. Normally distributed baseline data (age, BMI) were compared using an independent samples t-test. Nonnormally distributed data were compared using the chi-square test. For each outcome variable measured, between-group differences were assessed using the independent samples t-test or the Mann-Whitney U-test for continuous data and the chi-square test for categorical data. To highlight any significant changes in participants’ self-efficacy, repeated measures analysis of variance (ANOVA) and further comparative analysis were performed in each group. The statistical significance level was set at 0.05.