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

Primary Purpose

Dementia

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Online psychoeducation
Face-to-face psychoeducation
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia focused on measuring family caregivers, online, psychoeducation, self-efficacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Nethersole School of Nursing, Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Online psychoeducation

Face-to-face psychoeducation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
Recruitment rate
The proportion of eligible subjects and consented to join the study.
Attrition rate
The proportion of consented subjects who dropped out of the study. The reasons for attrition such as refusal were recorded.
Completion rate
The proportion of participants who attended at least 4 out of 6 sessions.
Class attendance
The proportion of participants who attended the class in each session
Completion rate of study instrument
The proportion of participants who completed the study instrument
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
Experience of online psychoeducation
Individual semi-structured interviews were conducted to explore the experience of online psychoeducation.

Secondary Outcome Measures

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.

Full Information

First Posted
September 8, 2023
Last Updated
September 18, 2023
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT06042634
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 15, 2022 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
January 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: Is online psychoeducation feasible and acceptable to family caregivers of people with dementia? 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
family caregivers, online, psychoeducation, self-efficacy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel arm of 1:1 ratio
Masking
Outcomes Assessor
Masking Description
Outcomes assessor was blinded to group allocation of participants
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Online psychoeducation
Arm Type
Experimental
Arm Description
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.
Arm Title
Face-to-face psychoeducation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Online psychoeducation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Face-to-face psychoeducation
Intervention Description
Face-to-face psychoeducation has the same content and flow of presentation as online psychoeducation.
Primary Outcome Measure Information:
Title
Sociodemographic background
Description
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
Title
Recruitment rate
Description
The proportion of eligible subjects and consented to join the study.
Time Frame
Through study completion, an average of 6 months
Title
Attrition rate
Description
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
Title
Completion rate
Description
The proportion of participants who attended at least 4 out of 6 sessions.
Time Frame
Through study completion, an average of 6 months
Title
Class attendance
Description
The proportion of participants who attended the class in each session
Time Frame
Through study completion, an average of 6 months
Title
Completion rate of study instrument
Description
The proportion of participants who completed the study instrument
Time Frame
Through study completion, an average of 6 months
Title
Satisfaction of intervention
Description
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
Title
Experience of online psychoeducation
Description
Individual semi-structured interviews were conducted to explore the experience of online psychoeducation.
Time Frame
On completion of intervention at 6 weeks
Secondary Outcome Measure Information:
Title
Caregiving self-efficacy
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hoi Man Chan, master
Organizational Affiliation
Nethersole School of Nursing, Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nethersole School of Nursing, Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Upon request to the principal investigator, Jackie Chan Hoi Man via email: 1010155350@link.cuhk.edu.hk
IPD Sharing Time Frame
2 years after completion of study and for 5 years

Learn more about this trial

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

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