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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-22

Study Completion Date

2027-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dementia Informal Caregivers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

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

Study Groups

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Daily-Activity-Focused, Strategy-Based Educational Program

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.

Group Type EXPERIMENTAL

Daily-Activity-Focused, Strategy-Based Educational Program

Intervention Type 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.

Usual Support Program

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.

Group Type ACTIVE_COMPARATOR

Usual Carer support

Intervention Type 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.

Interventions

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Daily-Activity-Focused, Strategy-Based Educational Program

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No