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Heart Failure Resilience Intervention for Caregivers (HEROIC)

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ClinicalTrials.gov Identifier: NCT03963583
Recruitment Status : Not yet recruiting
First Posted : May 24, 2019
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
Heart failure 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.

Condition or disease Intervention/treatment Phase
Heart Failure Caregivers Behavioral: HEROIC Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Heart Failure Resilience Intervention for Caregivers (HEROIC)
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HEROIC Intervention Group
This group will receive the HEROIC intervention.
Behavioral: HEROIC

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.

Experimental: Waitlist Control Group
The waitlisted group will receive usual care for caregivers for the first 16 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 16 weeks, they will begin the intervention.
Behavioral: HEROIC

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.




Primary Outcome Measures :
  1. Change in Goal Attainment of Preventive Health Behaviors as measured by the Goal Attainment Scale [ Time Frame: Baseline and 16 and 32 weeks post-intervention ]
    4-item, 5-point scale to measure self-perceived attainment of goals implementing health-promoting behaviors. Participants weight the importance and difficulty of each goal. Scores range from -2 to 2. Scores greater than zero indicate goal attainment, less than zero indicate negative progress.

  2. Change in Caregiver Burden as assessed by the Oberst Caregiving Burden Scale [ Time Frame: Baseline and 16 and 32 weeks post-intervention ]
    We will use the task difficulty and time caring subscales of the Oberst Caregiving Burden Scale, which include 15 likert scale items. Scores range from 15-75. Higher scores indicate great task difficulty and more time spent on each task, higher burden.

  3. Change in Quality of Life as assessed by the 36-Item Short Form Health Survey (SF-36) [ Time Frame: Baseline and 16 and 32 weeks post-intervention ]
    36-Item Short Form Health Survey (SF-36). There are 8 sub-scales. Items are scored on a 0-100 range, with total scores averaged for each subscale. The eight domains are also averaged to create an overall score from 0-100. Higher scores indicate a more favorable health state.


Secondary Outcome Measures :
  1. Change in Self-Efficacy as assessed by the Coping Self Efficacy Scale [ Time Frame: Baseline and 16 and 32 weeks post-intervention ]
    The coping self-efficacy scale has 13 items, each scored 0-10. Scores range from 0-130. Higher scores indicate higher coping self-efficacy.

  2. Change in Interleukin 6 levels (pg/mL) in sweat [ Time Frame: Baseline and 16 and 32 weeks post-intervention ]
    Participants will wear a non-occlusive sweatpatch to collect interleukin 6. Higher levels of interleukin 6 suggest increased activation of inflammatory response and decreased resilience to stress.

  3. Change in Interleukin 10 levels (pg/mL) in sweat [ Time Frame: Baseline and 16 and 32 weeks post-intervention ]
    Participants will wear a non-occlusive sweatpatch to collect interleukin 10. Higher levels of interleukin 10 suggest increased activation of the anti-inflammatory response and increased resilience to stress.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Caregiver of a patient who was hospitalized with a heart failure admission within 6 months
  • Agreement 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.

Exclusion Criteria:

  • Caregivers who themselves have a terminal diagnosis will be excluded as goal-setting at end of life may be different with a terminal diagnosis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03963583


Contacts
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Contact: Martha Abshire, PhD, BSN 443-340-6201 mabshir1@jhu.edu

Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Martha Abshire, PhD, BSN Johns Hopkins University School of Nursing

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03963583     History of Changes
Other Study ID Numbers: IRB00214452
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
Heart Failure
Caregivers
Resilience
Preventive Health Behaviors

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases