NCT07220798 · Visiting Nurse Service of New York
Improving Self-Care of Caregivers of Adults in Homecare With Heart Failure and Cognitive Impairment
(iCare4Me HC)
What this study is about
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).
View original scientific description
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. We will encourage caregivers to use their own devices but provide tablet devices with wireless network access if needed. The intervention group will receive 10 sessions of ViCCY over 6 months.
Interventions
BEHAVIORAL
ViCCY
The intervention group will receive 10 Health Coach sessions of ViCCY over 6-months.
Primary outcome measures
Short Form Health Survey (SF-36) (Both)
Time frame: Baseline, 3- and 6- and 12-months
Mental health is a state of mental well-being that enables people to cope with the stresses of life, realize their abilities, learn well and work well. The SF-36 provides standardized scores and national norms for comparison. The SF-36 is valid in many populations and caregivers. It is one of the common data elements.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patient Inclusion Criteria
- 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 Inclusion Criteria
- 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
Exclusion criteria
- Patient Exclusion Criteria
- Dementia (ICD-10 code for dementia)
- Enrolled in hospice
- Non-English speaking
- Caregiver Exclusion Criteria 1. Non-English speaking
Where
- New York, New York
Collaborators
University of Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 12, 2026 · Source of record for eligibility and locations