Clinical trial for Heart Failure
Official title Improving Self-Care of Caregivers of Adults in Homecare With Heart Failure and Cognitive Impairment
ClinicalTrials.gov ID: NCT07220798
What this study is testing
- What it's testing
- This RCT design will enroll 256 informal caregivers (spouse/partner or child) of HHC patients with HF/CI and 60 patients with HF and mild to moderate CI (60 dyads). After collecting baseline data, we will block randomize the caregivers 1:1 to the ViCCY intervention or comparator group, stratifying randomization by caregiver sex (male/female), relationship (spouse/partner or child), and race (white/other)- factors known to influence caregiving burden, perceived stress, and receptivity to the intervention.
- Time commitment: about 6 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 101
You may be able to join if
- Patient 1. Older adults (=\>50 years of age)
- Enrolled in Home Health Care
- Documented to have HF
- Mild to moderate CI on the BIMS or OASIS items
- Able to provide informed consent
You likely can't join if
- Patient Exclusion Criteria
- Dementia (ICD-10 code for dementia)
- Enrolled in hospice
- Non-English speaking
- Caregiver Exclusion Criteria 1. Non-English speaking
See the full eligibility criteria
- Patient 1. Older adults (=\>50 years of age)
- Enrolled in Home Health Care
- Documented to have HF
- Mild to moderate CI on the BIMS or OASIS items
- Able to provide informed consent
- Able to provide self-report data
- Caregiver 1. Adults (=\>18 years of age)
- Spouse/partner/child or other informal caregiver living with or in close proximity to the patient
- Caregiver of a home care patient who is currently receiving or recently received services and who has mild to severe cognitive impairment
- Reporting poor self-care on screening (Health Self-Care Neglect scale score =\>2)
- Reporting poor mental health on screening (screened with the PROMIS Global Mental Health 4a score \<12)
- Caregiving or supporting the patient at least 8 hours/week
- Able to complete the protocol, e.g., adequate vision and hearing, English speaking.
- Able to provide informed consent
- Able to use technology
- Patient Exclusion Criteria
- Dementia (ICD-10 code for dementia)
- Enrolled in hospice
- Non-English speaking
- Caregiver Exclusion Criteria 1. Non-English speaking
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 101 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.