Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-29 @ 8:52 AM
Study NCT ID:
NCT03378050
Status:
WITHDRAWN
Last Update Posted:
2021-04-20
First Post:
2017-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of a Multi-component Individualized Telephone-based Support Intervention for Adult-child Caregivers Caring for Parents With Dementia
Sponsor:
Yale University
Organization:
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study Never Began
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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?
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?
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: