Improving Self-care of Heart Failure Caregivers

NCT03988621 | Completed Phase 2 Results DMC

• 1 other identifier: 1R01NR018196
• Study Type: interventional
• Target: 343
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Self-care; Self-efficacy; Heart Failure; Stress; Support Systems

Outcome Measures

Primary Outcomes (2)

• Change in the Health Self-Care Neglect (HSCN) Scale

  The Health Self-Care Neglect (HSCN) scale measures an individual's neglect of self-care behaviors. It consists of 9 yes or no questions. Scores range from 0-9. Higher scores indicating more self-care neglect.

  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.

• Change in the Self-Care Inventory, Maintenance Scale

  The Self-Care Inventory is a 20 item inventory with 3 embedded scales (self-care maintenance, monitoring, and management). The outcome used in this study was the 8-item Self-Care Maintenance Scale. Responses are added and standardized to range from 0-100. A higher score indicates better self-care.

  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 (5)

• Change in the Perceived Stress Scale (PSS)

  Main analysis was Baseline to 6 months. Data will be analyzed at 12 months to determine sustainability of intervention effect.

• Change in the Ways of Coping Questionnaire

  The primary analysis was at 6 months (baseline compared to 6 months) but data were collected at 9- and 12-months to assess sustainability.

• Change in Health Status as Measured by the Short Form-36 (Physical and Mental Health Status)

  Main analysis Baseline to 6 months. Sustainability assessed at 12 months.

• Change in the Caregivers' SF-6D (Short Form Six-dimension) Scores

  Measured at baseline, 3, 6, 9, and 12 months; primary analysis baseline to 12 months

• Difference in Caregivers' Hospital and Provider Events

  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 (4)

• Difference in Patient Hospitalization Rate

  Count of patient hospitalizations that occurred between 6 and 12 months (following the intervention, which ended at 6 months)

• Patient Hospitalization Days

  Count of patient hospitalization days which occurred between 6 and 12 month timepoints

• Patient Mortality Rates

  Patient mortality occurring between months 6-12 of the study (following the intervention period)

Study Arms (2)

Intervention

EXPERIMENTAL

Caregivers randomized to the intervention ViCCY received 10 sessions of virtual health coaching by trained health coaches over 6 months with content based on the theoretical framework (the Transactional Model of Stress and Coping) and prior research. In addition, they received the same health information as that provided to the caregivers in the control arm. Sessions were provided through tablets. We helped caregivers gain the knowledge and skills needed to achieve self-identified health goals through self-care using motivational interviewing. We focused on identifying personal values, solving problems, and transforming goals into action. ViCCY was standardized in a treatment manual. Because stress does not affect all people equally, the intervention was tailored to individual appraisals and the factors most likely to influence demand and perceived burden.

Behavioral: ViCCY

Control

NO INTERVENTION

The control group received Health Information (HI) delivered through the internet.

Interventions

ViCCY BEHAVIORAL

Virtual Caregiver Coach for You

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania Hospital Heart and Vascular Clinic

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• 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.

  PMID: 38904103 RESULT

• Riegel B, Quinn R, Hirschman KB. A longitudinal comparative analysis of sustained benefit of a self-care intervention for caregivers of adults with heart failure. BMC Nurs. 2025 Nov 22;24(1):1501. doi: 10.1186/s12912-025-04123-4.

  PMID: 41272616 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

Limitations include enrollment from a single center although the center receives referrals from a diverse northeastern region of the US. Attrition was larger than anticipated and intervention engagement was variable. Although the sample enrolled was predominately White, female, and well-educated, it was large and diverse in many ways with almost 40% from groups who did not identify as White and almost 15% men.

Results Point of Contact

• Title: Barbara Riegel, PhD, RN, Professor
• Organization: University of Pennsylvania

briegel@nursing.upenn.edu

2158989927

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator was blinded to the assignment of participant to the two different arms in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: June 17, 2019
• Study Start: August 23, 2019
• Primary Completion: April 19, 2023
• Study Completion: October 19, 2023
• Last Updated: February 20, 2025
• Results First Posted: October 26, 2024

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting 6 months after publication of our major trial data, we will share data with Penn trainees.
• Access Criteria: The Principal Investigator will personally review requests from students for use of the data. She will approve requests based on the importance of the questions asked. She will personally oversee progress in analysis and the publication of abstracts and articles based on the data.

Locations

US (1)