Caregiver Burden, Cognitive Impairment, Heart Failure
Conditions
Keywords
heart failure, cognitive impairment, caregiver burden, caregiver stress, self-care, dyads
Brief 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 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.
Interventions
BEHAVIORALViCCY
The intervention group will receive 10 Health Coach sessions of ViCCY over 6-months.
Sponsors
Visiting Nurse Service of New York
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 101 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short Form Health Survey (SF-36) (Both) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-Care of Informal Caregiver Inventory (Caregiver) | Baseline, 3- and 6- and 12-months | Behaviors performed to maintain health |
| Perceived Stress Scale short form (Caregiver) | Baseline, 3- and 6- and 12-months | Demands exceed ability to cope |
| Brief-COPE (Caregiver) | Baseline, 3- and 6- and 12-months | Ability to respond to stressors with appropriate adaptive coping resources. |
| Dyadic Relationship Scale (Both) | Baseline, 3- and 6- and 12-months | Measure of strain in the dyadic relationship |
| HF Caregiver Questionnaire (Patient) | Baseline, 3- and 6- and 12-months | load experienced when caring for a loved one |
| Patient Health Questionnaire (PHQ-9) (Patient) | Baseline and 6-months | Measures signs and symptoms of depression. |
| Generalized Anxiety Disorder (GAD-7) (Patient) | Baseline and 6-months | Measures signs and symptoms of Anxiety. |
| HF Somatic Perception Scale (Patient) | Baseline and 6-months | Measures symptoms of Heart Failure. |
| Charlson Comorbidity Index (Patient) | Baseline and 6-months. | Captures patient Medications and Chronic Conditions. |
Countries
United States
Contacts
CONTACTBarbara Riegel, PhD, RN
CONTACTNicole Onorato, MPH
PRINCIPAL_INVESTIGATORBarbara Riegel, PhD, RN
VNS Health (formerly Visiting Nurse Service of New York)
Outcome results
None listed