An interventional study of Online psychoeducation and Face-to-face psychoeducation in Dementia, sponsored by Chinese University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-21.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Supportive care
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:
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.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's enrollment of 60 is below the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The online psychoeducation was presented virtually via Zoom videoconferencing for synchronous group meeting. It has two core components: didactic teaching and active participation. The didactic teaching provided information support about dementia caregiving which was delivered via Powerpoint presentations. The programme allowed: (1) hands-on skill training opportunities to rehearse caregiving skills through simulation and written assignments; (2) sharing of caregiving experiences and learning vicariously from other participants through group discussion; (3) reflection on own caregiving approach; and (4) addressing negative emotions through practicing relaxation technique. Participants went through six-weekly psychoeducation sessions in a small group of five to eight. Each psychoeducation session consisted of didactic teaching and active participation which lasted for 120 minutes. Participants went through discussion, simulation and was given home assignment weekly.
Behavioral: Online psychoeducation
Face-to-face psychoeducation had the same content and flow of presentation as online psychoeducation. The only difference was the mode of delivery which was presented physically in the community center.
Behavioral: Face-to-face psychoeducation
Online psychoeducation aimed to enhance the knowledge and skill of family caregivers of people with dementia, who could not physically attend in-person class. Knowledge covering dementia caregiving including disease nature, communication skill, stress and coping, daily care, management of behavioral and psychological symptoms of dementia, and future planning. The intervention provided opportunities to practice through simulation and weekly home assignment. There was a total of 6 sessions and provided weekly. Each session lasted for 2 hours. Participants had discussion with peers and coached by a facilitator. Online psychoeducation wad delivered via Zoom videoconferencing.
Face-to-face psychoeducation has the same content and flow of presentation as online psychoeducation.
Sociodemographic background
Caregiver: Age, gender, marital status, relationship with care recipient, caregiving experience, education level, level of confidence in caregiving; Care recipient: age, gender, duration of dementia since diagnose, level of assistance required in activity daily living, stage of dementia
Time frame: Baseline
Recruitment rate
The proportion of eligible subjects and consented to join the study.
Time frame: Through study completion, an average of 6 months
Attrition rate
The proportion of consented subjects who dropped out of the study. The reasons for attrition such as refusal were recorded.
Time frame: Through study completion, an average of 6 months
Completion rate
The proportion of participants who attended at least 4 out of 6 sessions.
Time frame: Through study completion, an average of 6 months
Class attendance
The proportion of participants who attended the class in each session
Time frame: Through study completion, an average of 6 months
Completion rate of study instrument
The proportion of participants who completed the study instrument
Time frame: Through study completion, an average of 6 months
Satisfaction of intervention
Participants rated on the content, format and appropriateness of intervention on a 5-point Likert scale. The higher total score represented greater satisfaction with the intervention
Time frame: On completion of intervention at 6 weeks
Experience of online psychoeducation
Individual semi-structured interviews were conducted to explore the experience of online psychoeducation.
Time frame: On completion of intervention at 6 weeks
Caregiving self-efficacy
Participants completed the Revised Scale of Caregiving Self-efficacy. There are 15 questions in total and participant rated on a scale of 0-100 on each question. The mean score of 15 questions will be presented and the higher the score represented the higher level of caregiving self-efficacy.
Time frame: Baseline and on completion of intervention at 6 weeks
Plan to share: Yes — Upon request to the principal investigator, Jackie Chan Hoi Man via email: 1010155350@link.cuhk.edu.hk
Supporting information: Sap, Icf, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chinese University of Hong Kong