A Feasibility Study of Online Psychoeducation for Family Caregivers of People With Dementia

Dementia Clinical Trial

Official title:

An Evidence-based Online Psychoeducation for Family Caregivers of People With Dementia: A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06042634
• Other study ID #: online psychoeducation
• Status: Completed
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: September 2023
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dementia

Intervention

Behavioral:
• Online 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
Face-to-face psychoeducation has the same content and flow of presentation as online psychoeducation.

Locations

Country	Name	City	State
Hong Kong	Nethersole School of Nursing, Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline
Primary	Recruitment rate	The proportion of eligible subjects and consented to join the study.	Through study completion, an average of 6 months
Primary	Attrition rate	The proportion of consented subjects who dropped out of the study. The reasons for attrition such as refusal were recorded.	Through study completion, an average of 6 months
Primary	Completion rate	The proportion of participants who attended at least 4 out of 6 sessions.	Through study completion, an average of 6 months
Primary	Class attendance	The proportion of participants who attended the class in each session	Through study completion, an average of 6 months
Primary	Completion rate of study instrument	The proportion of participants who completed the study instrument	Through study completion, an average of 6 months
Primary	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	On completion of intervention at 6 weeks
Primary	Experience of online psychoeducation	Individual semi-structured interviews were conducted to explore the experience of online psychoeducation.	On completion of intervention at 6 weeks
Secondary	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.	Baseline and on completion of intervention at 6 weeks