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临床试验/NCT07019441
NCT07019441Enrolling By Invitation不适用

A Daily-Activity-Focused, Strategy-Based Educational Programme for Informal Dementia Carers

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年4月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
90
试验地点
1
主要终点
Zarit Burden Inventory

研究概览

简要总结

This study will assess the impact of the Dementia Carer Education Programme on the caregiving burden of informal dementia carers.

Ninety informal dementia carers along with their care-recipients will be recruited and randomised to the experimental and control groups. All recruited dementia carers in the experimental group will receive the Dementia Carer Education Programme and the control group will receive usual carer support, both including one face-to-face education session and four follow-up sessions over 7 weeks. Caregiving burden will be assessed after receiving the programme. Statistical analysis of caregiving burden will follow the intention-to-treat principle, employing paired t-tests and linear modelling.

详细描述

Objective. To investigate the effectiveness of a Daily-Activity-Focused, Strategy-Based Educational Program for informal carers when helping people with dementia with daily activities using a randomised controlled trial design.

Participants. This part will recruit 'trainers' to deliver the program. Six healthcare professionals will recruit a total of 15 carers. A total of 90 carers will then be recruited.

Block randomisation will be used to randomise carers of each participating healthcare professional such that an equal number of carers are assigned to the 'Daily-Activity-Focused, Strategy-Based Educational Program' experimental or the 'usual carer support' control groups. Training will be provided to all participating healthcare professionals to deliver either the experimental or control program to carers.

All six healthcare professionals will have over five years of experience working with people with dementia and their carers.

Dyads (care-recipients and their carers) will be recruited. The inclusion criteria will be as follows: (1) the care-recipient has dementia; (2) the carer is the primary carer and assumes responsibility for the care-recipient; (3) the carer is at least 18 years old; and (4) primary care takes place at home. The exclusion criteria will be as follows: (1) the care-recipient's impairments in daily activities are primarily due to medical conditions other than dementia, such as stroke, and (2) the carer has a cognitive impairment that may hinder their understanding of and engagement with the programs.

研究设计

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

盲法说明

Blind assessors will collect data and they do not have any knowledge about participants' group assignment.

入排标准

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

入选标准

  • •the care-recipient has dementia;
  • •the carer is the primary carer and assumes responsibility for the care-recipient;
  • •the carer is at least 18 years old; and
  • •primary care takes place at home.

排除标准

  • •the care-recipient's impairments in daily activities are primarily due to medical conditions other than dementia, such as stroke, and
  • •the carer has a cognitive impairment that may hinder their understanding of and engagement with the programs.

研究组 & 干预措施

Daily-Activity-Focused, Strategy-Based Educational Program

Experimental

The intervention / experimental group will have one face-to-face education session, three follow-up telephone support sessions and a final home visit or phone call. Strategies to assist people with dementia with daily activities are compiled into the Carer Strategies Package. Healthcare professionals will deliver the program and work collaboratively with the informal carers to identify issues that arise during caregiving and problem-solve using the strategies included in the package.

干预措施: Daily-Activity-Focused, Strategy-Based Educational Program (Other)

Usual Support Program

Active Comparator

The control group will receive emotional support from healthcare professionals on the caring issues raised. They will be provided with resource information about dementia and care. It will also include the same number of sessions as the experimental group in which carers will discuss the caring difficulties and possible solutions with the healthcare professionals as well as access to online resources.

干预措施: Usual Carer support (Other)

结局指标

主要结局

Zarit Burden Inventory

时间窗: From enrollment to the end of program at 7 weeks

Zarit Burden Interview (ZBI) is a 22-question, paper-based self-reported questionnaire developed to be used with carers of people with dementia within the community. The overall score interpretation ranges from zero to 88, from 'little or no burden' to 'severe burden'.

次要结局

  • Adult Carer Quality of Life Questionnaire(From enrollment to the end of program at 7 weeks)
  • Alzheimer's Disease Cooperative Study- Activities of Daily Living Scale(From enrollment to the end of program at 7 weeks)

研究者

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

LIU Karen

Prof.

The Hong Kong Polytechnic University

研究点 (1)

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