Clinical trial NCT07019441: A Daily-Activity-Focused, Strategy-Based Educational Programme for Informal Dementia Carers
Official title: A Daily-Activity-Focused, Strategy-Based Educational Programme for Informal Dementia Carers
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Dementia
Informal Caregivers
Keywords: informal carers
dementia
carer education
daily activities
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Using the change in carer burden as the outcome, 45 dyads in each group, which would allow for a 10% estimated dropout, will give a power of 80%, an effect size of 0.25, and an alpha value of 0.05.

Daily-Activity-Focused, Strategy-Based Educational Program. Our pilot studies indicate that the proposed Educational Program will have one face-to-face education session and three follow-up telephone support sessions. Strategies to assist 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.

Usual Carer support. 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.

Data collection. The demographic information of the participating healthcare professionals, care-recipients and carers will be collected before the program. Medical and functional data on the care-recipients will be collected. The outcome measures used will be administered to the carers before and immediately after the program.

Outcome measures. The primary outcome measures include (1) Zarit Burden Inventory (ZBI). The secondary outcome measures include (2) Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale (ADCS-ADL); and (3) Adult Carer Quality of Life Questionnaire (AC-QoL). Other secondary outcome measures include the number of Emergency Department visits, hospital admissions and length of stay, aged care facility admissions and length of stay. They will be recorded six months after the program.

Statistical analysis. Descriptive statistics will be reported for all data collected. Two-way repeated-measure analysis of variance (ANOVA) will be used to compare the primary outcomes collected pre- and post-program between the two groups. The difference in the secondary outcomes between the two groups will be compared.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Zarit Burden Inventory
timeFrame: From enrollment to the end of program at 7 weeks
Secondary outcomes:
measure: Adult Carer Quality of Life Questionnaire
timeFrame: From enrollment to the end of program at 7 weeks
measure: Alzheimer's Disease Cooperative Study- Activities of Daily Living Scale
timeFrame: From enrollment to the end of program at 7 weeks
Other outcomes:
measure: Number of Emergency Department visits
timeFrame: Six months after the educational program
measure: Number of hospital admissions
timeFrame: Six months after the educational program
measure: length of hospital stay
timeFrame: Six months after the educational program
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Karen P. Y. Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.