Clinical trial NCT03988621: Improving Self-care of Heart Failure Caregivers
Official title: Improving Self-Care of Informal Caregivers of Adults With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure
Keywords: Self-care
Self-efficacy
Heart Failure
Stress
Support Systems
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2019-06-17
Enrollment: 343
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was based on the Transactional Model of Stress and Coping. Stressful experiences such as caregiving demand - circumstances that give rise to real or perceived stress - are construed as person-environment transactions. Primary appraisal of demand involves assessment of its significance, which results in perceived burden. Secondary appraisal involves assessment of the resources available to cope with it. These appraisals lead to the coping effort. Without successful coping, self-care is poor, which decreases health status in caregivers. The virtual support intervention \[ViCCY ("Vicky") - Virtual Caregiver Coach for You\] addressed both appraisal and coping.
Primary purpose: TREATMENT

Brief summary: Informal caregiving is demanding and stressful. Caregivers of adults with heart failure (HF) report significant stress and poor self-care. Health coaching, a support intervention, may relieve stress and promote self-care in HF caregivers. Few studies have tested the cost-effectiveness of support interventions for caregivers. Even less is known about the effect of caregiver support interventions on HF outcomes. We developed and tested a virtual support intervention (ViCCY ("Vicky")-Virtual Caregiver Coach for you), in HF caregivers. Using randomized controlled trial (RCT) design, we enrolled informal HF caregivers with poor self-care (Health Self-Care Neglect scale score\>=2), randomizing them 1:1 to an intervention or control group. Both groups received Health Information (HI) delivered through the Internet, but the ViCCY caregiver group also received 10 health coaching support sessions tailored to individual issues. The control group had access to the same HI resources over the same interval, using the same Internet program, but without coaching support. At baseline and 3, 6, 9, and 12 months, we collected self-reported data on self-care, stress, coping, and health status. At 6 months, we compared ViCCY to HI alone to assess intervention efficacy using intent-to-treat analysis. A sample of 250 caregivers (125/arm) was enrolled to provide \>90% power to detect significant differences between the groups on the primary outcome of self-care (Aim 1). We collected quality adjusted life years (QALYs) and health care resource use in caregivers over 12 months to assess cost-effectiveness of ViCCY (Aim 2). To explore the effect of caregiver outcomes on HF patients' outcomes (hospitalization rates, hospital days, mortality rates, QALYs) over a 12-month period (Aim 3) and knowing that not all HF patients would enroll, we consented a subgroup of 93 HF patients cared for by these caregivers to explore the effect of caregiver self-care on patient outcomes. If shown to be efficacious and cost-effective, our virtual health coaching intervention can easily scaled to support millions of caregivers worldwide. This application addresses the NINR strategic plan and is directly responsive to PA-18-150.

Detailed description: We used a randomized controlled trial (RCT) design, randomizing informal heart failure (HF) caregivers meeting our inclusion and exclusion criteria 1:1 to an intervention or control group. After collecting baseline data, we block randomized the caregivers to achieve equal distribution of key variables in each condition. We will block randomize on caregiver sex (male/female), relationship to patient (e.g., spouse), and race. Sex and relationship are factors known to influence perceived caregiving burden and receptivity to intervention. Race was included to assure group balance. The randomization sequence was generated a priori by a statistician independent of the study investigators using a randomly permuted blocks algorithm to ensure equal distribution of these variables in each study arm. The Project Manager notified study staff and participants of their group assignment (intervention or control) by telephone, email or message, as preferred by the individual. Investigators and all staff involved in collecting assessment data were blinded to group assignment until after the data were locked. The health coach providing the intervention and the caregiver participants were not be blinded. All baseline data were collected prior to randomizing. Timing of follow-up assessments were based on day of randomization.

The study intervention was provided to individual caregivers. All caregivers (both groups) were provided with access to an Internet site with excellent health information (HI). The virtual support intervention (ViCCY \["Vicky"\] - Virtual Caregiver Coach for You) was provided through tablet devices provided to caregivers in the intervention group. We provided tablets to all the caregivers, assuring that they had wireless network access so they can access the Internet site providing HI content. Caregivers in the control group received only HI but caregivers in the intervention group received 10 sessions of ViCCY over 6 months.

Eligibility criteria: Inclusion Criteria: Informal caregiver of adults with heart failure providing care at least 8 hours/week, reporting poor self-care on screening (Health Self-Care Neglect scale score \>=2 based on our pilot data), able to complete the protocol, e.g., adequate vision and hearing, and English speaking were required for enrollment.

Exclusion Criteria: Cognitive impairment (Telephone Interview for Cognitive Status \[TICS\] \<25), Participation in another clinical trial of a support intervention, Untreated major psychiatric illness (Use of anti-anxiety/antidepressant medicines was acceptable and will be adjusted in analysis if group imbalance is identified).

Primary outcomes:
measure: Change in the Health Self-Care Neglect (HSCN) Scale
timeFrame: The primary outcome was analyzed at 6 months (baseline compared to 6 months) but data were collected at 9- and 12-months to assess sustainability.
measure: Change in the Self-Care Inventory, Maintenance Scale
timeFrame: The primary outcome was analyzed at 6 months (baseline compared to 6 months) but data were collected at 9- and 12-months to assess sustainability.
Secondary outcomes:
measure: Change in the Perceived Stress Scale (PSS)
timeFrame: Main analysis was Baseline to 6 months. Data will be analyzed at 12 months to determine sustainability of intervention effect.
measure: Change in the Ways of Coping Questionnaire
timeFrame: The primary analysis was at 6 months (baseline compared to 6 months) but data were collected at 9- and 12-months to assess sustainability.
measure: Change in Health Status as Measured by the Short Form-36 (Physical and Mental Health Status)
timeFrame: Main analysis Baseline to 6 months. Sustainability assessed at 12 months.
measure: Change in the Caregivers' SF-6D (Short Form Six-dimension) Scores
timeFrame: Measured at baseline, 3, 6, 9, and 12 months; primary analysis baseline to 12 months
measure: Difference in Caregivers' Hospital and Provider Events
timeFrame: Data were collected at Baseline, 3, 6, 9, and 12 months. The primary analysis was done using the baseline to 12 month period.
Other outcomes:
measure: Difference in Patient Hospitalization Rate
timeFrame: Count of patient hospitalizations that occurred between 6 and 12 months (following the intervention, which ended at 6 months)
measure: Patient Hospitalization Days
timeFrame: Count of patient hospitalization days which occurred between 6 and 12 month timepoints
measure: Patient Mortality Rates
timeFrame: Patient mortality occurring between months 6-12 of the study (following the intervention period)
measure: Change in the Patients' Quality Adjusted Life Years (QALYs) Measured With the SF-6D (Short Form Six-dimension) Derived From the Short Form-36
timeFrame: QALYs were measured at baseline, 3, 6, 9, and 12 months. But this analysis focused on the baseline to 12 month period.
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Hospital Heart and Vascular Clinic
state: Pennsylvania
Study officials:
References:
citation: Riegel B, Quinn R, Hirschman KB, Thomas G, Ashare R, Stawnychy MA, Bowles KH, Aryal S, Wald JW. Health Coaching Improves Outcomes of Informal Caregivers of Adults With Chronic Heart Failure: A Randomized Controlled Trial. Circ Heart Fail. 2024 Jul;17(7):e011475. doi: 10.1161/CIRCHEARTFAILURE.123.011475. Epub 2024 Jun 21.