Heart Failure Resilience Intervention for Caregivers

NCT03963583 | Completed Results

• 2 other identifiers: IRB002778141K12HD085845
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Heart failure (HF) patients with supportive caregivers have better physical health, emotional health, and quality of life. But caregivers have an increased risk of caregivers' own worsening health and often feel a sense of burden related to caregiving. However, caregivers receive very little support to balance caring for the patient with caring for themselves. Therefore, this research will provide a program for caregivers of advanced heart failure patients to build on the caregiver's strengths, sense of purpose, and set goals for healthy lifestyle changes. The investigators believe that caregivers who receive the program will have better quality of life, less sense of burden, and a healthier lifestyle.

Conditions

Heart Failure; Caregivers

Keywords

Heart Failure; Caregivers; Resilience; Preventive Health Behaviors

Outcome Measures

Primary Outcomes (3)

• Goal Attainment of Preventive Health Behaviors as Measured by the Goal Attainment Scale

  The Goal Attainment Scale is a self-reported attainment of goals implementing health-promoting behaviors, reported on a 5-point scale. Scores are converted to t-scores (0-100). 50 indicates the population mean with a standard deviation of 10. Higher scores indicate higher goal attainment.

  Baseline, 12 and 24 weeks

• Caregiver Burden as Assessed by the Oberst Caregiving Burden Scale

  Investigators will use the task difficulty and time caregiving subscales of the Oberst Caregiving Burden Scale. Both sub-scales include 15 likert scale items each. Scores range from 15-75 for the task difficulty and 15-75 for the time caregiving sub-scales. Higher scores indicate great task difficulty; higher scores indicate more time spent caregiving. Sub-scales are not combined in a total score.

  Baseline, 12 and 24 weeks

• Quality of Life as Assessed by the Neurological Quality of Life(Neuro-QOL)

  9-Item Neurological Quality of Life (Neuro-QOL). Items are scored on a 1-5 range, with total summary score calculated range of 9-45. Higher scores indicate a more favorable quality of life.

  Baseline, 12 and 24 weeks

Secondary Outcomes (1)

• Self-Efficacy as Assessed by the Coping Self Efficacy Scale

  Baseline, 12 and 24 weeks

Study Arms (2)

HEROIC Intervention Group

EXPERIMENTAL

This group will receive the HEROIC intervention.

Behavioral: HEROIC

Waitlist Control Group

EXPERIMENTAL

The waitlisted group will receive usual care for caregivers for the first 12 weeks, which is normally limited to inclusion in some clinical assessment and teaching during patient visits. Waitlisted participants will receive monthly study postcards to encourage retention. After 12 weeks, they will begin the intervention.

Behavioral: HEROIC

Interventions

HEROIC BEHAVIORAL

The HEROIC intervention will include individualized, nurse-led sessions focused on; 1. a whole-person assessment including preventive health behaviors, personal goals, and purpose in life 2. discussion of caregiving in the context of the caregiver's identified 'purpose' which supports meaning-making and provides rationale for goal-setting 3. co-development of a plan to address caregiver goals to improve preventive health behaviors and/or reduce caregiver burden 4. 'walking meetings' to model the importance of exercise while discussing incremental action plans to help caregivers achieve goals.

HEROIC Intervention Group; Waitlist Control Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Caregivers of patients served by the HF Bridge Clinic will be included if
• the patient was hospitalized within 6 months
• the caregiver agrees to work on goals that increase preventive health behaviors and/or decrease burden
• caregivers live with the patient or visit them to provide care more than 3 times per week
• the caregiver is 50 years or older and e) the caregiver is the spouse/partner or child of the patient.

You may not qualify if:

• Caregivers who
• themselves have a terminal diagnosis
• or are cognitively impaired based on Mini-Mental State Examination (MMSE) screening will be excluded as response to the intervention may vary in these groups.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Johns Hopkins School of Nursing

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Martha Abshire Saylor
• Organization: Johns Hopkins University School of Nursing

mabshir1@jhu.edu

4433406201

Study Officials

• Martha Abshire Saylor, PhD

  Johns Hopkins University School of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 24, 2019
• Study Start: April 1, 2022
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: November 24, 2025
• Results First Posted: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Immediately following publication. No end date
• Access Criteria: The data may be used for any purpose. We will establish an online weblink.

Locations

US (1)