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

NCT06042634 | Completed

• 1 other identifier: online psychoeducation
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Dementia

Keywords

family caregivers; online; psychoeducation; self-efficacy

Outcome Measures

Primary Outcomes (8)

• 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

• Recruitment rate

  The proportion of eligible subjects and consented to join the study.

  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.

  Through study completion, an average of 6 months

• Completion rate

  The proportion of participants who attended at least 4 out of 6 sessions.

  Through study completion, an average of 6 months

• Class attendance

  The proportion of participants who attended the class in each session

  Through study completion, an average of 6 months

• Completion rate of study instrument

  The proportion of participants who completed the study instrument

  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

  On completion of intervention at 6 weeks

• 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 Outcomes (1)

• Caregiving self-efficacy

  Baseline and on completion of intervention at 6 weeks

Study Arms (2)

Online psychoeducation

EXPERIMENTAL

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

ACTIVE COMPARATOR

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

Interventions

Online psychoeducation BEHAVIORAL

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.

Online psychoeducation

Face-to-face psychoeducation BEHAVIORAL

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

Face-to-face psychoeducation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Nethersole School of Nursing, Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Hoi Man Chan, master

  Nethersole School of Nursing, Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor was blinded to group allocation of participants
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Student

Model Details: Parallel arm of 1:1 ratio

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 18, 2023
• Study Start: July 15, 2022
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR
• Time Frame: 2 years after completion of study and for 5 years

Locations

HK (1)