Clinical trial NCT03378050: A Trial of a Multi-component Individualized Telephone-based Support Intervention for Adult-child Caregivers Caring for Parents With Dementia
Official title: Efficacy and Feasibility of a Multi-component Individualized Telephone-based Support Intervention for Adult-child Caregivers Caring for Parents With Dementia in China: Study Protocol of a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dementia
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, controlled trial (RCT) will be used to compare a 12-week intervention group with a waiting-list control group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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?

Eligibility criteria: 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).

Primary outcomes:
measure: Caregiver Burden
timeFrame: 12 weeks
Secondary outcomes:
measure: Caregiver Burden
timeFrame: Baseline, 6 weeks and 24 weeks
measure: Health Related Quality of Life
timeFrame: Baseline, 6 weeks, 12 weeks and 24 weeks
measure: Reciprocal Filial Piety
timeFrame: Baseline, 6 weeks, 12 weeks and 24 weeks
measure: BPSD
timeFrame: Baseline, 6 weeks, 12 weeks and 24 weeks
measure: Satisfaction with and benefits from the Intervention
timeFrame: 12 weeks and 24 weeks
Other outcomes:
Locations:
Study officials:
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