Heart FailureiCare4Me HCNCT07220798
Improving Self-Care of Caregivers of Adults in Homecare With Heart Failure and Cognitive Impairment
A study testing ViCCY in people with Heart Failure and Cognitive Impairment, run by Visiting Nurse Service of New York at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 101 years
- Conditions the study is for
- Heart Failure, Cognitive Impairment, Caregiver Burden
- What is being tested?
- ViCCY
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2026to 28 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 101 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
- Patient Exclusion Criteria
- Dementia (ICD-10 code for dementia)
- Enrolled in hospice
- Non-English speaking
- Caregiver Exclusion Criteria 1. Non-English speaking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VNS Health
New York, New York, 10017
Barbara Riegel, PhD, RN, FAHA, FAAN, 215.898.9927, briegel@nursing.upenn.edu
Nicole Onorato, MPH, 2126095770, nicole.onorato@vnshealth.org
About this study
Official title: Improving Self-Care of Caregivers of Adults in Homecare With Heart Failure and Cognitive Impairment (iCare4Me Homecare)
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.
Read the detailed description
Purpose and Specific Aims
Cognitive Impairment (CI) has been reported to be as high as 78% in older adults with Heart Failure (HF). CI markedly increases the risk of adverse HF outcomes such as hospitalization and death, and patients with CI and HF are rarely able to manage without a caregiver. The high level of caregiving demands lead to an increase in stress and strained relationships with caregiving recipients, which can lead to poor coping and decreased mental health among caregivers. This study aims to test a self-care intervention (Virtual Caregiver Coach for You -ViCCY) targeting caregivers to support mental health and explore whether changes in caregiver mental health impacts patient outcomes. We will examine relationship strain as the primary mechanism for improvements in outcomes in patients and caregivers.
Aim 1: Test the efficacy of ViCCY vs. UC in improving outcomes of caregivers of home health care (HHC) patients with HF/CI.
Aim 2: Explore the effect of ViCCY on outcomes in HHC patients with HF/CI. At 6-months we will report differences in mental health measured with the SF-36 and its contributors of depression, anxiety, and somatic HF symptoms between patients whose caregivers are randomized to ViCCY compared to UC.
Aim 3: Describe the mechanisms by which outcomes are achieved.
Overview of Study Design and Methods
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.
Participant Recruitment and Data Collection
Participants will be (256) caregivers of community dwelling older adults with HF/CI and 60 dyads (caregivers and patients) with HF and mild to moderate CI.
Data Sources and Analysis
We will use an intent-to-treat approach with the primary outcomes assessed at baseline, 3- and 6-months, and 12-months. Efficacy will be analyzed at 6-months. We will summarize participant characteristics using descriptive statistics. Shapiro-Wilk and Levin's tests will be used to assess distributional assumptions of normality. Mixed effects regression models will be used to assess intervention efficacy. Outcomes will be assessed using pre-post self-reported survey data.
- Conditions
- Heart Failure, Cognitive Impairment, Caregiver Burden
- Being tested
- ViCCY
- Keywords
- heart failure, cognitive impairment, caregiver burden, caregiver stress, self-care, dyads
- Medical subject headings
- Heart Failure, Cognitive Dysfunction, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViCCYBehavioural
The intervention group will receive 10 Health Coach sessions of ViCCY over 6-months.
| Study group | Role | What they receive |
|---|---|---|
| ViCCY Intervention | Experimental | The intervention group will receive 10 sessions of ViCCY over 6-months. Receives: Behavioral: ViCCY |
| Usual Care | No intervention | Usual Home Health Care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Form Health Survey (SF-36) (Both)
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.
Measured: Baseline, 3- and 6- and 12-months
Secondary outcomes (9)
Self-Care of Informal Caregiver Inventory (Caregiver)
Behaviors performed to maintain health
Measured: Baseline, 3- and 6- and 12-months
Perceived Stress Scale short form (Caregiver)
Demands exceed ability to cope
Measured: Baseline, 3- and 6- and 12-months
Brief-COPE (Caregiver)
Ability to respond to stressors with appropriate adaptive coping resources.
Measured: Baseline, 3- and 6- and 12-months
Dyadic Relationship Scale (Both)
Measure of strain in the dyadic relationship
Measured: Baseline, 3- and 6- and 12-months
HF Caregiver Questionnaire (Patient)
load experienced when caring for a loved one
Measured: Baseline, 3- and 6- and 12-months
Patient Health Questionnaire (PHQ-9) (Patient)
Measures signs and symptoms of depression.
Measured: Baseline and 6-months
Generalized Anxiety Disorder (GAD-7) (Patient)
Measures signs and symptoms of Anxiety.
Measured: Baseline and 6-months
HF Somatic Perception Scale (Patient)
Measures symptoms of Heart Failure.
Measured: Baseline and 6-months
Charlson Comorbidity Index (Patient)
Captures patient Medications and Chronic Conditions.
Measured: Baseline and 6-months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2025
- Study start28 May 2026
- Primary completion28 Apr 2030 (estimated)
- Study completion28 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is based on both the Transactional Model of Stress and Coping and the Dyadic Health Behavior Change model. The stressor for caregivers is the demand of caregiving. This stressor commonly causes stress in the relationship. The response to this stressor is influenced by appraisal of the stress, resources, problem management, and support resources, factors used in the ViCCY intervention. In patients, caregiver stress, combined with the stress of illness, accentuates cognitive, affective, and somatic symptoms, thereby impairing mental health. Interdependence is captured in the Dyadic Health Behavior Change model, which emphasizes the individual contributions of both the patient and the caregiver while simultaneously recognizing the synergy of the relationship.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Visiting Nurse Service of New York
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Barbara Riegel, PhD, RN, Principal investigator, VNS Health (formerly Visiting Nurse Service of New York)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220798
- Sponsor's protocol ID
- 1R01AG094822
- Acronym
- iCare4Me HC
- Status last verified
- Aug 2026
- First submitted
- 22 Oct 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Self-Care of Caregivers of Adults in Homecare With Heart Failure and Cognitive Impairment (iCare4Me Homecare)
- ClinicalTrials.gov ID
- NCT07220798
- Acronym / sponsor ID
- iCare4Me HC / 1R01AG094822
- Conditions
- Heart Failure, Cognitive Impairment, Caregiver Burden
- Keywords
- heart failure, cognitive impairment, caregiver burden, caregiver stress, self-care, dyads
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- Visiting Nurse Service of New YorkUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- 28 May 2026 (actual)
- Primary completion
- 28 Apr 2030 (estimated)
- Study completion
- 28 Apr 2030 (estimated)
- First posted
- 24 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Purpose and Specific Aims
Cognitive Impairment (CI) has been reported to be as high as 78% in older adults with Heart Failure (HF). CI markedly increases the risk of adverse HF outcomes such as hospitalization and death, and patients with CI and HF are rarely able to manage without a caregiver. The high level of caregiving demands lead to an increase in stress and strained relationships with caregiving recipients, which can lead to poor coping and decreased mental health among caregivers. This study aims to test a self-care intervention (Virtual Caregiver Coach for You -ViCCY) targeting caregivers to support mental health and explore whether changes in caregiver mental health impacts patient outcomes. We will examine relationship strain as the primary mechanism for improvements in outcomes in patients and caregivers.
Aim 1: Test the efficacy of ViCCY vs. UC in improving outcomes of caregivers of home health care (HHC) patients with HF/CI.
Aim 2: Explore the effect of ViCCY on outcomes in HHC patients with HF/CI. At 6-months we will report differences in mental health measured with the SF-36 and its contributors of depression, anxiety, and somatic HF symptoms between patients whose caregivers are randomized to ViCCY compared to UC.
Aim 3: Describe the mechanisms by which outcomes are achieved.
Overview of Study Design and Methods
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.
Participant Recruitment and Data Collection
Participants will be (256) caregivers of community dwelling older adults with HF/CI and 60 dyads (caregivers and patients) with HF and mild to moderate CI.
Data Sources and Analysis
We will use an intent-to-treat approach with the primary outcomes assessed at baseline, 3- and 6-months, and 12-months. Efficacy will be analyzed at 6-months. We will summarize participant characteristics using descriptive statistics. Shapiro-Wilk and Levin's tests will be used to assess distributional assumptions of normality. Mixed effects regression models will be used to assess intervention efficacy. Outcomes will be assessed using pre-post self-reported survey data.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is based on both the Transactional Model of Stress and Coping and the Dyadic Health Behavior Change model. The stressor for caregivers is the demand of caregiving. This stressor commonly causes stress in the relationship. The response to this stressor is influenced by appraisal of the stress, resources, problem management, and support resources, factors used in the ViCCY intervention. In patients, caregiver stress, combined with the stress of illness, accentuates cognitive, affective, and somatic symptoms, thereby impairing mental health. Interdependence is captured in the Dyadic Health Behavior Change model, which emphasizes the individual contributions of both the patient and the caregiver while simultaneously recognizing the synergy of the relationship.
| Arm | Type | Receives |
|---|---|---|
| ViCCY Intervention | Experimental | Behavioral: ViCCYThe intervention group will receive 10 sessions of ViCCY over 6-months. |
| Usual Care | No intervention | –Usual Home Health Care. |
Who may qualify
- Ages
- 18 to 101 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patient Inclusion Criteria
- Caregiver Inclusion Criteria
Key exclusion criteria (5 listed)
- Patient Exclusion Criteria
- Caregiver Exclusion Criteria 1. Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ViCCYThe intervention group will receive 10 Health Coach sessions of ViCCY over 6-months. | Behavioural | ViCCY Intervention |
Primary outcome
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.
9 secondary outcomes
Self-Care of Informal Caregiver Inventory (Caregiver)
Time frame: Baseline, 3- and 6- and 12-months
Perceived Stress Scale short form (Caregiver)
Time frame: Baseline, 3- and 6- and 12-months
Brief-COPE (Caregiver)
Time frame: Baseline, 3- and 6- and 12-months
Dyadic Relationship Scale (Both)
Time frame: Baseline, 3- and 6- and 12-months
HF Caregiver Questionnaire (Patient)
Time frame: Baseline, 3- and 6- and 12-months
Patient Health Questionnaire (PHQ-9) (Patient)
Time frame: Baseline and 6-months
Generalized Anxiety Disorder (GAD-7) (Patient)
Time frame: Baseline and 6-months
HF Somatic Perception Scale (Patient)
Time frame: Baseline and 6-months
Charlson Comorbidity Index (Patient)
Time frame: Baseline and 6-months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Barbara Riegel, PhD, RN principal investigator
VNS Health (formerly Visiting Nurse Service of New York)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ViCCY in people with Heart Failure and Cognitive Impairment, run by Visiting Nurse Service of New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbara Riegel, PhD, RN (215.898.9927, briegel@nursing.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Form Health Survey (SF-36) (Both) (time frame: Baseline, 3- and 6- and 12-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.