Improving Self-care of Heart Failure Caregivers

Sponsor
University of Pennsylvania (Other)
Overall Status
Recruiting
CT.gov ID
NCT03988621
Collaborator
(none)
290
Enrollment
1
Location
2
Arms
52.3
Anticipated Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: ViCCY
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
290 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The proposed study is 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] addresses both appraisal and coping.The proposed study is 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] addresses both appraisal and coping.
Masking:
Single (Investigator)
Masking Description:
The investigator will be blinded to the assignment of participant to the two different arms in the study.
Primary Purpose:
Treatment
Official Title:
Improving Self-Care of Informal Caregivers of Adults With Heart Failure
Actual Study Start Date :
Aug 23, 2019
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

  1. Change in the Health Self-Care Neglect Scale [The primary outcome will be analyzed at 6 months (baseline compared to 6 months)]

    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.

  2. Change in the Self-Care Inventory [The primary outcome will be analyzed at 6 months (baseline compared to 6 months)]

    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.

Secondary Outcome Measures

  1. Change in the Perceived Stress Scale [Baseline, 3, 6, 9, and 12 months.]

    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.

  2. Change in the Ways of Coping questionnaire [Baseline, 3, 6, 9, and 12 months.]

    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.

  3. Change in Health Status (physical and mental health status) [Baseline, 3, 6, 9, and 12 months.]

    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.

  4. Change in the Medical Outcomes Study short form 6-dimension (SF-6D) [Baseline, 3, 6, 9, and 12 months]

    derived from the SF-36 and used in the cost-effectiveness analysis

  5. Difference in hospital and provider events [Baseline, 3, 6, 9, and 12 months]

    measure of acute care resource use

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1University of Pennsylvania Hospital Heart and Vascular ClinicPhiladelphiaPennsylvaniaUnited States19104

Sponsors and Collaborators

  • University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Barbara Riegel, PHD, RN, Investigator, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT03988621
Other Study ID Numbers:
  • 1R01NR018196
First Posted:
Jun 17, 2019
Last Update Posted:
Oct 7, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Barbara Riegel, PHD, RN, Investigator, University of Pennsylvania
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 7, 2021