Ignite Creation Date:
2024-05-06 @ 1:41 PM
Last Modification Date:
2024-10-26 @ 1:18 PM
Study NCT ID:
NCT04090749
Status:
COMPLETED
Last Update Posted:
2023-12-22
First Post:
2019-09-12
Brief Title:
Caregiver Support in the Context of Multiple Chronic Conditions
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Caregiver Support in the Context of Multiple Chronic Conditions Randomized Waitlist Control Trial
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research is being done to learn whether services to the caregiver to provide emotional instrumental and social support can improve quality of life and other outcomes The Caregiver-Support program provides services that are not usually available to caregivers of persons with heart failure and other chronic conditions
Detailed Description:
Family caregivers who care for older adults living with multiple chronic conditions including heart failure HF provide substantial cost savings to the US healthcare system While caregiving can be meaningful and rewarding extensive research also demonstrates high rates of chronic disease fatigue and physiologic measures such as stress hormones among caregivers Family caregivers are often left juggling caregivers loved ones healthcare as well as caregivers own Unmet needs have been identified including increased stress financial strain and social isolation but interventions to address these needs in HF caregivers have had mixed results Due to the limited impact of many caregiver interventions experts have called for a greater understanding of the dynamic and contextual factors of family caregiving including resources needs and social support with an increased focus on individualization of interventions for high-risk caregivers to improve outcomesFollowing a mixed methods study to better understand these contextual factors and to address this gap between the evidence and uptake of proven strategies by caregivers the study team has developed a resilience-promoting intervention to improve quality of life for family caregivers of individuals with multiple chronic conditions including HF Caregiver-Support Caregiver-Support will help caregivers articulate statements of purpose in life set goals to address fatigue and caregiver burden provide instrumental support through a benefits check up and promote identification and increased connection with the caregivers social network
The first phase of the study will be an open label pilot N5 followed by a single-masked two-group randomized trial N40 to test the feasibility and gauge an initial effect size of the intervention Participants will be visited by study staff in participants homes for all data collection and intervention visits Participants will be randomized to receive either the immediate intervention group or the waitlist control group In the waitlist control group participants will receive usual care for the first 16 weeks which is limited to printed materials provided in the clinic and then begin the intervention
The intervention will consist of 5 in-home sessions with a nurse interventionist Each participant will receive each intervention component but interventionists will systematically tailor content to the participants goals based on protocols All participants will be reassessed at 16 weeks in person and 32 weeks by phone by a research assistant RA masked to treatment condition The primary outcome will be improvement in quality of life between baseline and 16 weeks Other endpoints include group differences in fatigue caregiver burden self-reported and physiological measures of resilience up through 32 weeks after the intervention The investigators will also examine the acceptability of the intervention using intervention compliance and participant satisfaction data
The first phase of the study will be an open label pilot N5 followed by a single-masked two-group randomized trial N40 to test the feasibility and gauge an initial effect size of the intervention Participants will be visited by study staff in participants homes for all data collection and intervention visits Participants will be randomized to receive either the immediate intervention group or the waitlist control group In the waitlist control group participants will receive usual care for the first 16 weeks which is limited to printed materials provided in the clinic and then begin the intervention
The intervention will consist of 5 in-home sessions with a nurse interventionist Each participant will receive each intervention component but interventionists will systematically tailor content to the participants goals based on protocols All participants will be reassessed at 16 weeks in person and 32 weeks by phone by a research assistant RA masked to treatment condition The primary outcome will be improvement in quality of life between baseline and 16 weeks Other endpoints include group differences in fatigue caregiver burden self-reported and physiological measures of resilience up through 32 weeks after the intervention The investigators will also examine the acceptability of the intervention using intervention compliance and participant satisfaction data
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5P30NR018093 | NIH | None | httpsreporternihgovquickSearch5P30NR018093 |