Improving Self-care of Heart Failure Caregivers

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03988621
• Other study ID #: 1R01NR018196
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 23, 2019
• Est. completion date: May 31, 2024

Study information

• Verified date: June 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 342
• Est. completion date: May 31, 2024
• Est. primary completion date: April 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Behavioral:
• ViCCY
Virtual Health Coaching for You

Locations

Country	Name	City	State
United States	University of Pennsylvania Hospital Heart and Vascular Clinic	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	Difference in hospital and provider events	measure of acute care resource use	Baseline, 3, 6, 9, and 12 months