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Improving Self-Care of Caregivers of Adults in Homecare With Heart Failure and Cognitive Impairment

Improving Self-Care of Caregivers of Adults in Homecare With Heart Failure and Cognitive Impairment (iCare4Me Homecare)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 101 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 months
  • Procedures mentioned: Pills, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Outcomes will be assessed using pre-post self-reported survey data."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ViCCY, a program to help caregivers take better care of themselves. It is for caregivers of adults in home health care who have heart failure and problems with memory or thinking. Caregivers are placed by chance into the ViCCY group, with 10 sessions over 6 months, or a comparison group.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Patients: Age 50 or older, enrolled in home health care, and have heart failure, which means the heart does not pump as well as it should.
  • Patients: Have mild to moderate memory or thinking problems on a screening test.
  • Patients: Can agree to join the study and answer questions about themselves.
  • Caregivers: Age 18 or older and a spouse, partner, child, or other informal caregiver who lives with or near the patient.
  • Caregivers: Care for someone who gets or recently got home care and has mild to severe memory or thinking problems.
  • Caregivers: Screening tests show poor self-care and poor mental health.
  • Caregivers: Give care or support for at least 8 hours each week.
  • Caregivers: Can agree to join, use technology, speak English, and complete study tasks, including having enough sight and hearing.

Who can't join

  • Patients: Have a recorded diagnosis of dementia, a condition that affects memory and thinking.
  • Patients: Receive hospice care, which focuses on comfort near the end of life.
  • Patients and caregivers: Do not speak English.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Patient Inclusion Criteria 1. Older adults (=\>50 years of age) 2. Enrolled in Home Health Care 3. Documented to have HF 4. Mild to moderate CI on the BIMS or OASIS items 5. Able to provide informed consent 6. Able to provide self-report data * Caregiver Inclusion Criteria 1. Adults (=\>18 years of age) 2. Spouse/partner/child or other informal caregiver living with or in close proximity to the patient 3. Caregiver of a home care patient who is currently receiving or recently received services and who has mild to severe cognitive impairment 4. Reporting poor self-care on screening (Health Self-Care Neglect scale score =\>2) 5. Reporting poor mental health on screening (screened with the PROMIS Global Mental Health 4a score \<12) 6. Caregiving or supporting the patient at least 8 hours/week 7. Able to complete the protocol, e.g., adequate vision and hearing, English speaking. 8. Able to provide informed consent 9. Able to use technology Exclusion Criteria: * Patient Exclusion Criteria 1. Dementia (ICD-10 code for dementia) 2. Enrolled in hospice 3. Non-English speaking * Caregiver Exclusion Criteria 1. Non-English speaking

Study sites (1)

NY