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HEROIC Program for Caregivers of Heart Failure Patients (HEROIC Trial)
N/A
Recruiting
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
HEROIC Trial 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.Check my eligibility
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.See study design
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.
HEROIC Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Change in Self-Efficacy as assessed by the Coping Self Efficacy Scale
HEROIC 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?
Johns Hopkins UniversityLead Sponsor
2,263 Previous Clinical Trials
14,823,120 Total Patients Enrolled
21 Trials studying Heart Failure
4,725 Patients Enrolled for Heart Failure
National Institutes of Health (NIH)NIH
2,700 Previous Clinical Trials
7,508,519 Total Patients Enrolled
35 Trials studying Heart Failure
7,841 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have been approved for this research project?
"Affirmative. The information on clinicaltrials.gov confirms that this research study, which was posted on April 1st 2022, is recruiting patients. 41 test subjects are needed from a single medical institution."
Answered by AI
Does this research endeavor have any open slots for participants?
"Affirmative. According to the information provided by clinicaltrials.gov, this medical study is open for recruitment as of June 10th 2022, when it was last updated. The trial initially began on April 1st and they are searching for 41 volunteers at a single site."
Answered by AI
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