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临床试验/NCT06042634
NCT06042634已完成不适用

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

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Completion rate

研究概览

简要总结

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?

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

Outcomes assessor was blinded to group allocation of participants

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Completion rate

时间窗: Through study completion, an average of 6 months

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

Sociodemographic background

时间窗: Baseline

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

Attrition rate

时间窗: Through study completion, an average of 6 months

The proportion of consented subjects who dropped out of the study. The reasons for attrition such as refusal were recorded.

Completion rate of study instrument

时间窗: Through study completion, an average of 6 months

The proportion of participants who completed the study instrument

Class attendance

时间窗: Through study completion, an average of 6 months

The proportion of participants who attended the class in each session

Recruitment rate

时间窗: Through study completion, an average of 6 months

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

Satisfaction of intervention

时间窗: On completion of intervention at 6 weeks

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

时间窗: On completion of intervention at 6 weeks

Individual semi-structured interviews were conducted to explore the experience of online psychoeducation.

次要结局

  • Caregiving self-efficacy(Baseline and on completion of intervention at 6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chan Hoi Man Jackie

Doctoral Student

Chinese University of Hong Kong

研究点 (1)

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