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HEROIC Program for Caregivers of Heart Failure Patients (HEROIC Trial)
N/A
Waitlist Available
Led By Martha Abshire Saylor, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 and 24 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial will provide a program for caregivers of advanced heart failure patients to help improve their quality of life, sense of burden, and health.
Who is the study for?
This trial is for caregivers aged 50 or older of advanced heart failure patients who were hospitalized within the last 6 months. Caregivers must be willing to work on health goals, live with or visit the patient frequently, and be a spouse/partner or child of the patient. Those with terminal illnesses or cognitive impairment are excluded.
What is being tested?
The HEROIC program is being tested to see if it can improve quality of life, reduce burden, and promote healthier lifestyles among caregivers of heart failure patients by focusing on their strengths and setting personal health goals.
What are the potential side effects?
Since this intervention involves a supportive program rather than medication, traditional side effects are not expected; however, participants may experience emotional responses as they engage in self-care practices.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 12 and 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 and 24 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Caregiver Burden as assessed by the Oberst Caregiving Burden Scale
Change in Goal Attainment of Preventive Health Behaviors as measured by the Goal Attainment Scale
Change in Quality of Life as assessed by the Neurological Quality of Life(Neuro-QOL)
Secondary study objectives
Change in Self-Efficacy as assessed by the Coping Self Efficacy Scale
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Waitlist Control GroupExperimental Treatment1 Intervention
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.
Group II: HEROIC Intervention GroupExperimental Treatment1 Intervention
This group will receive the HEROIC intervention.
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Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,817 Previous Clinical Trials
8,161,714 Total Patients Enrolled
35 Trials studying Heart Failure
7,821 Patients Enrolled for Heart Failure
Johns Hopkins UniversityLead Sponsor
2,327 Previous Clinical Trials
14,874,569 Total Patients Enrolled
24 Trials studying Heart Failure
9,979 Patients Enrolled for Heart Failure
Martha Abshire Saylor, PhDPrincipal InvestigatorJohns Hopkins University School of Nursing
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Eligibility Criteria:
This trial includes the following eligibility criteria:- If you are a caregiver and have a serious illness or memory problems, you cannot participate because the treatment may work differently for you.I am a caregiver, over 50, helping a patient frequently and willing to work on health goals.I was hospitalized for heart failure in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Waitlist Control Group
- Group 2: HEROIC Intervention Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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