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

NCT07019441 | Enrolling By Invitation

• 1 other identifier: HongKongPU_Dementia carer edu
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dementia; Informal Caregivers

Keywords

informal carers; dementia; carer education; daily activities

Outcome Measures

Primary Outcomes (1)

• Zarit Burden Inventory

  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'.

  From enrollment to the end of program at 7 weeks

Secondary Outcomes (2)

• 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

Other Outcomes (3)

• Number of Emergency Department visits

  Six months after the educational program

• Number of hospital admissions

  Six months after the educational program

• length of hospital stay

  Six months after the educational program

Study Arms (2)

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.

Other: Daily-Activity-Focused, Strategy-Based Educational Program

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.

Other: Usual Carer support

Interventions

Daily-Activity-Focused, Strategy-Based Educational Program OTHER

The proposed Educational Program will have one face-to-face education session and three follow-up telephone support sessions. Strategies to assist the people with dementia with daily activities, developed from our prior work, have been compiled into a Strategies Package. Healthcare professionals will deliver the program and work collaboratively with the carers to identify issues that arise during caregiving and problem-solve using the strategies included in the package. Carers are provided with support and are encouraged to locate an appropriate strategy using the Strategies Package to help them assist in a daily task in which they want their care recipient to engage.

Daily-Activity-Focused, Strategy-Based Educational Program

Usual Carer support OTHER

This group will receive emotional support from trainers on the caring issues raised. It will include the same number of sessions as in the experimental group.

Usual Support Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong, Hong Kong

Location

Related Publications (2)

• Burridge G, Amato C, Bye R, Basic D, Ni Chroinin D, Hill S, Howe K, Liu KPY. Strategies adopted by informal carers to enhance participation in daily activities for persons with dementia. Australas J Ageing. 2024 Dec;43(4):683-691. doi: 10.1111/ajag.13341. Epub 2024 May 28.

  PMID: 38804160 BACKGROUND

• Amato C, Burridge G, Basic D, Huynh D, Gibbons E, Ni Chroinin D, Liu KPY. Assistance provided in daily tasks and difficulty experienced by caregivers for people living with dementia. Aust Occup Ther J. 2021 Jun;68(3):236-245. doi: 10.1111/1440-1630.12720. Epub 2021 Feb 2.

  PMID: 33533025 BACKGROUND

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

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

Study Officials

• Karen P. Y. Liu, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blind assessors will collect data and they do not have any knowledge about participants' group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: June 13, 2025
• Study Start: April 22, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)