Clinical trial NCT06042634: A Feasibility Study of Online Psychoeducation for Family Caregivers of People With Dementia
Official title: An Evidence-based Online Psychoeducation for Family Caregivers of People With Dementia: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: family caregivers
online
psychoeducation
self-efficacy
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel arm of 1:1 ratio
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to evaluate the feasibility and acceptability of online psychoeducation in the family caregivers of people with dementia living in the community. The main objectives it aims to answer are:

1. Is online psychoeducation feasible and acceptable to family caregivers of people with dementia?
2. What is the preliminary effect of online psychoeducation on caregiving self-efficacy in family caregivers of people with dementia?

Detailed description: This study employed a quasi-experimental pretest-posttest design to compare online psychoeducation with conventional face-to-face psychoeducation. This study also included a qualitative study as process evaluation to explore the participants' experiences with the online psychoeducation.

Caregivers of people with dementia were recruited from two sources: elderly community centers and Facebook. Printed flyers were physically displayed in the elderly community centers and advertisements were posted on Facebook. Interested participants approached the principal investigator through telephone and were screened for eligibility. Informed consent was collected physically at the elderly community centers or via Google Forms.

The feasibility study required 30 participants per arm to test the intervention before a future definitive trial. Therefore, with two groups in this study, the total sample size was set at 60.

Participants recruited from the elderly community centers were allocated to the face-to-face group, whilst participants recruited from Facebook were allocated to the online group. The rationale for having a non-randomized design was to prevent potential contamination occurring due to information sharing among the participants. Participants were informed of the group allocation at the time of recruitment.

The sociodemographic data and outcomes were collected by an research assistant. All participants were also asked to complete the satisfaction questionnaire at T1. Questions for the satisfaction questionnaire and caregiving self-efficacy questionnaire were read out to participants.

Quantitative data were analyzed using the IBM SPSS Statistics version 26.0. Descriptive statistics were used to summarize the demographic data and the feasibility outcomes including recruitment rate, attrition rates, completion rate of intervention, participants' satisfaction score and completion rate of instrument. Chi-square test for the categorical variables and independent T-test for the continuous variables were used to examine the homogeneity of the participants in the two intervention groups. Analysis of Covariance was performed to examine between group differences in Revised Scale of Caregiving Self-Efficacy (RSCSE) score, with the respective pretest score as covariate. Paired T-test was also performed to examine within group differences in RSCSE score. Effect size was measured by dividing the mean difference within the group by the pooled standard deviation and reported as Cohen's d value. The cut-off points of small, medium and large effect size were 0.2, 0.5 and 0.8 respectively. All analysis was considered significant at p≤ 0.05 (2-tailed).

The audio-recorded interviews were transcribed verbatim for qualitative content analysis. The transcripts were managed with the support of Nvivo 14 for systematic organization of the data. The authors read the transcripts multiple times to get familiar with the data. They then coded the data and developed initial themes independently. Critical discussion and revision on the themes and subthemes were carried out until a consensus was reached. The main themes and subthemes were refined and named collaboratively. Illustrative quotes were selected through critical discussion between authors. The first author translated the quotes to English while the other authors helped with verification and proofreading.

Eligibility criteria: Inclusion Criteria:

* cognitively competent (i.e. Mini Mental State Examination ≥23)
* taking care of a family member diagnosed with dementia of mild to moderate stage and required assistance in physical activities of daily living (ADL) (i.e. score ≥2 on the ADL scale
* at least 5 hours of caregiving per week in the past month
* had low caregiving self-efficacy (i.e. score ≤3 on the Caregiving Competence Scale

Exclusion Criteria:

* currently participating in any other psychosocial interventional program
* had psychiatric illnesses and had active treatment
* did not had access to the Internet on any type of electronic device such as smart phone or laptop.

Primary outcomes:
measure: Sociodemographic background
timeFrame: Baseline
measure: Recruitment rate
timeFrame: Through study completion, an average of 6 months
measure: Attrition rate
timeFrame: Through study completion, an average of 6 months
measure: Completion rate
timeFrame: Through study completion, an average of 6 months
measure: Class attendance
timeFrame: Through study completion, an average of 6 months
measure: Completion rate of study instrument
timeFrame: Through study completion, an average of 6 months
measure: Satisfaction of intervention
timeFrame: On completion of intervention at 6 weeks
measure: Experience of online psychoeducation
timeFrame: On completion of intervention at 6 weeks
Secondary outcomes:
measure: Caregiving self-efficacy
timeFrame: Baseline and on completion of intervention at 6 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Nethersole School of Nursing, Chinese University of Hong Kong
Study officials:
affiliation: Nethersole School of Nursing, Chinese University of Hong Kong
name: Hoi Man Chan, master
role: PRINCIPAL_INVESTIGATOR
References: