A Trial of a Multi-component Individualized Telephone-based Support Intervention for Adult-child Caregivers Caring for Parents With Dementia

Yale University

Status: Withdrawn

Conditions: Dementia

Treatments: Other: Usual Care; Behavioral: HEART

Study type: Interventional

Funder types: Other

Identifiers

NCT03378050

Yu12.17

Details and patient eligibility

About

This is the first randomized controlled trial exploring the implementation of a multi-component individualized telephone-based support intervention for adult-child caregivers caring for parents with dementia in China. Results hold the potential to inform the further development of family caregiver supportive services.

Full description

The objectives of this study are to evaluate the efficacy and feasibility of a multi-component individualized telephone-based support intervention (HEART) for adult-child caregivers caring for parents with dementia in China.

The primary hypothesis to test is whether the HEART is more efficacious in reducing caregiver burden than the follow-up as usual (FU) in dementia adult-child caregivers.

Secondary hypotheses include the following:

1. The HEART is more efficacious in improving health related quality of life than the FU in dementia adult-child caregivers.
2. The HEART is more efficacious in protecting reciprocal Filial Piety than the FU in dementia adult-child caregivers.
3. The HEART is more efficacious in relieving CR's behavioral and psychological symptoms of dementia (BPSD) than the FU in dementia adult-child caregivers.
4. The HEART group has a higher satisfaction with the intervention than the FU group.

In addition, two research questions will be answered by qualitative data from process evaluation for the feasibility of the HEART intervention. The research questions are as follows:

1. To what extent can the HEART intervention be delivered as planned?
2. What are the barriers to and facilitators of the HEART intervention?

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary caregivers being adult children (age 18 or older) who have spent at least 2 hours per day over the last 3 months caring for a parent with a diagnosis of dementia.
• Must have telephone access.
• Caregivers will not end their primary caregiving role within 6 months of study enrollment.

Exclusion criteria

• Cognitive impairment or intellectual disability.
• Those who are providing care for another relative with chronic physical or mental diseases.
• Pregnant women (Because it is unlikely that this group would be primary caregivers except in exceptional circumstances, the consideration of which was beyond the scope of this research).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Intervention group

Experimental group

Description:

The intervention group will receive a multi-component individualized support intervention "HEART", which will consist of 12 sessions in four stages.

Treatment:

Behavioral: HEART

Control group

Active Comparator group

Description:

Participants is the control group will be placed on a waiting list for 12 weeks. They will receive the intervention, after they complete the 12-week follow-up assessment. Caregivers in the control group will receive 12 week follow-up as usual (FU) including two brief "check-in" calls and an outcome measures call during the study period.

Treatment:

Other: Usual Care