Setting and study design
This research is a randomized clinical trial with two groups and a pre-test and post-test design conducted based on the CONSORT checklist, (Figure1). For this purpose, Consolidated Standards of Reporting Trials checklist was employed to report the findings of the study, (S1, CONSORT checklist).
This study aimed to investigate the effects of FCEM on depression, anxiety, and stress among the family caregivers of patients with COVID-19. The four-stage of FCEM in four online sessions through WhatsApp was provided to the intervention group from the patient's discharge until 2 weeks later. Consequently, the demographic information questionnaire and Depression Anxiety Stress Scale-21 were employed to collect the data, before and five days after the FCEM sessions.
Populations, inclusion, and exclusion criteria
The statistical polulation includes 70 family caregivers from Torbat-e Heydariyeh with inclusion criteria participated in the study from April to July 2020. Inclusion criteria for patients include patients with confirmed COVID-19 who were treated and discharged, aged 18-60 years old, and with no underlying diseases other than COVID-19. Exclusion criteria of patients include dying of patient, presence of other diseases, and readmission. The following inclusion criteria were used for family caregivers: family member caring for a patient with COVID-19, family caregiver’s access to communication devices such as mobile phones, personal computers, and tablets equipped with WhatsApp, reading and writing skills, and not being a member of the healthcare team. Exclusion criteria for family caregivers include ages less than 18 and more than 60 years, absence in more than one educational session, and unwillingness to continue the study.
Instruments of measurement:
Data collection instruments include a demographic information questionnaire with six items (age, sex, marital status, living place, patient-caregiver relationship, and education) and the DASS-21 that assessed depression, anxiety, and stress among family caregivers of patients with COVID-19. This questionnaire was first presented by Lovibond PF and Lovibond SH in 1995[21]. The 21-item questionnaire is on a Likert scale, and each of the three DASS-21 scales contains seven items. Stress assesses fear, shortness of breath, tremors, dry mouth, palpitation, difficulty in starting work, and difficulty in relaxing. Anxiety evaluates autonomic arousal, situational anxiety, skeletal muscle effects, and subjective experience of apprehension distress. Depression measures self-depreciation, life devaluation, hopelessness, dysphoria, the feeling of indifference/sedentary, and anhedonia [22]. Two research team members (Mehdipour and Najafi)reviewed and approved the validity and reliability of the DASS-21 [23, 24]. Besides, the quality content validity method was used to determine the validity of the DASS-21. The DASS-21 was provided to 10 faculty members of Torbat-e Heydariyeh University of Medical Sciences for evaluation, and the ultimate instrument was used once required suggestions and modifications were implemented. To confirm the reliability (internal consistency) of the study, we tested the DASS-21 tool on 10 subjects and the obtained Cronbach's alpha coefficient was 0.81. The total score of each DASS-21 subscale is obtained through the item scores related to that subscale. Each item is scored from zero (did not apply to me at all) to three (applied to me very much). Since this questionnaire is a short form of the original version (42 items), the final score of each subscale must be doubled. The DASS-21 and demographic information questionnaire were prepared online and the link was sent electronically to the family caregivers of patients with COVID-19 by WhatsApp Messenger.
Sample size and randomization:
The necessary sample size was estimated as a result of a pilot study on 20 family caregivers (10 individuals in each group) with a 95 percent confidence interval and 80 percent test power. Thirty-four family caregivers were included in each group by using the following formula:
Concerning 10 percent dropout, 38 family caregivers were considered in each group. Three family caregivers from the intervention group (two family caregivers due to unwillingness to continue the study and one family caregiver due to absence in educational sessions) and three from the control group (due to unwillingness to resume the study) were excluded from the study and finally, 35 families in each group were examined.
The primary caregivers were randomly assigned to control and intervention groups. Eligible patients were divided into two groups of intervention or control based on a random sequence of letters A and B, generated by SPSS software, written on small cards, and retained in a sealed envelope. Then, one card would be picked out of the envelope at the beginning of each week to decide if we should conduct the intervention during that week or it is time for the control. Accordingly, all eligible inpatients would be allocated to either the control or intervention group. Furthermore, this approach would rule out the possibility of information dissemination among those patients who are accidentally in the ward
Pre-intervention
In the intervention group, an introductory session was held with family caregivers at the time of patients' discharges from the health clinic of the hospital. First, online FCEM sessions were arranged based on participants’ agreements. Then, the priorities, educational needs, and skills required to care for the patient with COVID-19 were assessed through a checklist. The important educational problems and needs of caregivers, including the disease identification, personal hygiene, methods of prevention and transmission of infection, drug use, nutrition and excretion, daily life activities, mental and psychological issues were extracted. After reviewing the needs and skills required, the researcher designed the educational content according to the literature and ideas of the research team and infectious disease specialists.
Intervention
The educational content of the online sessions was designed through a checklist based on the needs of the research units. Then, the FCEM was presented as online group discussions in five groups of seven individuals in four 40-60 minute sessions through WhatsApp and other applications used for this purpose. The FCEM was provided to the intervention group from the patient's discharge until 2 weeks later during the lockdown. The intervention, was performed in four steps consist of perceived threat, problem-solving, educational participation and evaluation, (Supplementary material 1).
Post-intervention
The intervention and control groups were evaluated five days after the FCEM sessions. The researcher made a telephone call to the caregivers as a reminder and discuss any potential issues., the link to the DASS-21 was resent to the caregivers electronically.
Control:
The ptients in the control group would only experience face-to-face training (recommendation for medication and quarantine) during discharge and they used the pamphlets available in the ward, which was the same for the intervention group. All educational contents of the FCEM sessions were provided to the control group after the research.
Statistical analysis
The obtained information was statistically analyzed with SPSS version 16. Descriptive statistics (frequency distribution, mean, standard deviation) were used to describe and categorize the data. On the other hand, inferential statistics including Chi-square, independent t- and Mann-Whitney tests were used to assess the hypothesis. Paired t-test was employed to make within-group comparison. Finally, Kolmogorov-Smirnov test was implemented to examine normal distribution of quantitative variables. The 95-percent confidence level and the significance level of 0.05 were considered in all the tests.