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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ViCCY Intervention | Experimental | The intervention group will receive 10 sessions of ViCCY over 6-months. |
|
| Usual Care | No Intervention | Usual Home Health Care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ViCCY | Behavioral | The intervention group will receive 10 Health Coach sessions of ViCCY over 6-months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 3- and 6- and 12-months |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Care of Informal Caregiver Inventory (Caregiver) | Behaviors performed to maintain health | Baseline, 3- and 6- and 12-months |
| Perceived Stress Scale short form (Caregiver) | Demands exceed ability to cope |
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Inclusion Criteria:
Patient Inclusion Criteria
Caregiver Inclusion Criteria
Exclusion Criteria:
Patient Exclusion Criteria
Caregiver Exclusion Criteria 1. Non-English speaking
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Barbara Riegel, PhD, RN | Contact | 215.898.9927 | briegel@nursing.upenn.edu | |
| Nicole Onorato, MPH | Contact | 212-609-5770 | Nicole.Onorato@vnshealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Barbara Riegel, PhD, RN | VNS Health (formerly Visiting Nurse Service of New York) | Principal Investigator |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D060825 | Cognitive Dysfunction |
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
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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.
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Investigators and all staff involved in collecting assessment data will be blinded to group assignment until after the data are locked. The coach providing the intervention, Dr. Hirschman (fidelity), and the caregiver participants will not be blinded.
| Baseline, 3- and 6- and 12-months |
| Brief-COPE (Caregiver) | Ability to respond to stressors with appropriate adaptive coping resources. | Baseline, 3- and 6- and 12-months |
| Dyadic Relationship Scale (Both) | Measure of strain in the dyadic relationship | Baseline, 3- and 6- and 12-months |
| HF Caregiver Questionnaire (Patient) | load experienced when caring for a loved one | Baseline, 3- and 6- and 12-months |
| Patient Health Questionnaire (PHQ-9) (Patient) | Measures signs and symptoms of depression. | Baseline and 6-months |
| Generalized Anxiety Disorder (GAD-7) (Patient) | Measures signs and symptoms of Anxiety. | Baseline and 6-months |
| HF Somatic Perception Scale (Patient) | Measures symptoms of Heart Failure. | Baseline and 6-months |
| Charlson Comorbidity Index (Patient) | Captures patient Medications and Chronic Conditions. | Baseline and 6-months. |
| D001523 |
| Mental Disorders |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |