Improving Self-care of Heart Failure Caregivers

Improving Self-Care of Informal Caregivers of Adults With Heart Failure

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 have developed and pilot tested a virtual support intervention (ViCCY ("Vicky")-Virtual Caregiver Coach for you), that we propose to evaluate among HF caregivers. Using randomized controlled trial (RCT) design, we will enroll 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 will receive standard care augmented with Health Information (HI) delivered through the Internet, but the ViCCY caregiver group will also receive 10 front-loaded coaching support sessions tailored to individual issues. The control group will have 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 will collect self-reported data on self-care, stress, coping, and health status. At 6 months, we will compare ViCCY to HI alone to assess intervention efficacy using intent-to-treat analysis. Our pilot data suggest that addition of support provided by the health coach will make ViCCY more efficacious than HI alone. A sample of 250 caregivers (125/arm) will provide >90% power to detect significant differences between the groups on the primary outcome of self-care (Aim 1). We will collect 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 will participate, we will consent a subgroup of the HF patients cared for by these caregivers (at least 40 dyads). 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Behavioral: ViCCY

Detailed Description

We will use 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 will block randomize the caregivers to achieve equal distribution of key variables in each condition. We will block randomize on caregiver sex (male/female) and relationship to patient (e.g., spouse) - factors shown to influence perceived caregiving burden and receptivity to intervention. The randomization sequence will be 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 will notify the study staff and participants of their group assignment (intervention or control) by telephone, email or message, as preferred by the individual. Although balance in sample size can be achieved with block randomization, the groups may not be fully comparable on other factors. Initial comparison of the groups will allow us to control for important covariates in the analyses. Investigators and all staff involved in collecting assessment data will be blinded to group assignment until after the data are locked. The nurse providing the intervention and the caregiver participants will not be blinded. All baseline data will be collected prior to randomizing. Timing of follow-up assessments will be based on day of randomization.

The study intervention will be provided to individual caregivers. All caregivers (both groups) will be provided with access to an Internet site with excellent health information (HI). In addition, we have developed and pilot tested a virtual support intervention (ViCCY ["Vicky"] - Virtual Caregiver Coach for You), that we will provide on tablet devices to caregivers in the intervention group. We will provide tablets to all the caregivers, assuring that they have wireless network access so they can access the Internet site providing HI content. Caregivers in the control group will receive only HI but caregivers in the intervention group will receive 10 front-loaded sessions of ViCCY over 6 months.

• Study Type: Interventional
• Enrollment (Actual): 342
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Gladys L Thomas, LMSW,MBA; Phone Number: 215-898-5089; Email: glthomas@nursing.upenn.edu
• Study Contact Backup: Name: Barbara Riegel, PhD, RN; Phone Number: 215-898-9927; Email: briegel@nursing.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Hospital Heart and Vascular Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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, English speaking, and living within 50 miles of the research office in case home visits are required for enrollment or Internet set-up.

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 is acceptable and will be adjusted in analysis if group inbalance is identified), and plans to move out of the area imminently.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Caregivers randomized to the intervention ViCCY will receive 10 front-loaded sessions of virtual health coaching by trained registered nurses over 6 months with content based on the theoretical framework (based on the Transactional Model of Stress and Coping) and prior research. Sessions are provided using tablets. Initially, sessions are weekly but the frequency decreases over time as needed. We help caregivers gain the knowledge and skills needed to achieve self-identified health goals through self-care using motivational interviewing. We focus on identifying personal values, solving problems, and transforming goals into action. ViCCY is standardized in a treatment manual. Because stress does not affect all people equally, the intervention is tailored to individual appraisals and the factors most likely to influence demand and perceived burden.	Behavioral: ViCCY; Virtual Health Coaching for You
No Intervention: Health Information; The Health Information (HI) group will receive health resource information delivered through the internet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Health Self-Care Neglect Scale	Self-care refers to those behaviors undertaken to maintain health. The scale is a 9- item dichotomous scale with demonstrated reliability (alpha 0.76) and content validity. Scores range from 0-9 with higher scores indicating more self-care neglect.	The primary outcome will be analyzed at 6 months (baseline compared to 6 months)
Change in the Self-Care Inventory	30 items scored 0-100. A higher score indicates better self-care. This theoretically-derived instrument has construct validity. The self-care confidence scale is embedded within this instrument.	The primary outcome will be analyzed at 6 months (baseline compared to 6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Perceived Stress Scale	The Perceived Stress Scale, a 14-item instrument that provides a global rating of an individual's belief in the severity and frequency of stressful experiences during the last month. The Perceived Stress Scale includes 14 items designed to assess symptoms of stress and global measures of the degree of stress experienced in the past month. Each item is scored from 0 (never) to 4 (very often), with total sum scores ranging from 0 to 56; higher scores indicate higher perceived stress. Cronbachs alpha of the scale ranges from 0.84 to 0.86, and was 0.91 for older African American and European American females.	Baseline, 3, 6, 9, and 12 months.
Change in the Ways of Coping questionnaire	This 42-item questionnaire measures the use of five different coping styles: avoidance, problem-focused, seeking social support, self-blame, and wishful thinking. The original scale has been used widely since developed by Lazarus in 1985. The short version (30 items) uses a 4-point Likert-scale response format (0 = not used to 3 = used a great deal). Scores range from 0-90 with higher scores indicating greater coping. It is reliable (alpha 0.95) and has construct validity. This instrument has been used numerous times in studies with older adult caregivers.	Baseline, 3, 6, 9, and 12 months.
Change in Health Status (physical and mental health status)	Medical Outcomes Study Short Form (SF-36): measure of physical and mental health.The SF-36 has 36 items formatted in scales of varied format (3-, 5- and 6-pt scales and dichotomous [yes/no] scales). Each component score is standardized a 0-100 point scale. Reliability is varied samples is typically 0.80. Convergent and divergent validity have been demonstrated in various populations, including caregivers. A benefit of using the SF-36 is that it is one of the common data elements.	Baseline, 3, 6, 9, and 12 months.
Change in the Medical Outcomes Study short form 6-dimension (SF-6D)	derived from the SF-36 and used in the cost-effectiveness analysis	Baseline, 3, 6, 9, and 12 months
Difference in hospital and provider events	measure of acute care resource use	Baseline, 3, 6, 9, and 12 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2019
• Primary Completion (Actual): April 19, 2023
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: May 22, 2019
• First Submitted That Met QC Criteria: June 13, 2019
• First Posted (Actual): June 17, 2019

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Heart Failure; Stress; Self-efficacy; Self-care; Support Systems
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 1R01NR018196 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Plan to share the data internally with doctoral students and post-doctoral trainees instead of sharing the data widely with external sources. Internal sharing will allow our trainees to complete meaningful studies using secondary analysis techniques and to finish their programs in a timely fashion.
• IPD Sharing Time Frame: Starting 6 months after publication of our major trial data, we will share data with Penn trainees.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No