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Family-focused Literacy Strategies for Heart Failure (FamLit_HF Trial)
N/A
Recruiting
Research Sponsored by Jia-Rong Wu
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years of age or older
Confirmed diagnosis of heart failure (HF), either systolic or diastolic HF
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
FamLit_HF Trial Summary
This trial will test a new intervention to help people with heart failure who don't take their medications as prescribed. The hope is that by coaching patients and their care partners, they will be able to build skills to overcome their individual barriers to adherence. This could lead to improved medication adherence, fewer hospitalizations, and a better quality of life.
Who is the study for?
This trial is for adults with heart failure who've been on stable heart medication for at least 3 months, can manage their own meds, and have a care partner involved in their care. Participants must be willing to use an electronic pillbox and attend coaching sessions. Excluded are those with terminal illnesses, substance abuse issues, recent hospitalizations, communication barriers or cognitive impairments.Check my eligibility
What is being tested?
The study tests 'FamLit', a nurse-led intervention using simple language to improve how patients with heart failure and their care partners handle medication adherence. The goal is to enhance adherence, reduce hospital visits and improve life quality by addressing individual barriers together.See study design
What are the potential side effects?
Since the intervention involves educational strategies rather than medications or medical procedures, there may not be direct side effects like those associated with drugs; however participants might experience stress or anxiety from changes in routine or increased focus on medication adherence.
FamLit_HF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have been diagnosed with heart failure.
Select...
I manage and take my own medications.
FamLit_HF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Medication adherence
Self-reported medication adherence.
Secondary outcome measures
Patient hospitalization
Positive Affect
Quality of life - Minnesota Living with Heart Failure
Other outcome measures
Caregiver Burden
Communication
Health Literacy
+3 moreFamLit_HF Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Patients - FamLitExperimental Treatment1 Intervention
Patients with a confirmed diagnosis of heart failure.
Group II: Care Partners - FamLitExperimental Treatment1 Intervention
Care partners of patients with a confirmed diagnosis of heart failure.
Group III: Care Partners - Attention OnlyActive Control1 Intervention
Care partners of patients with a confirmed diagnosis of heart failure.
Group IV: Patients - Attention OnlyActive Control1 Intervention
Patients with a confirmed diagnosis of heart failure.
Find a Location
Who is running the clinical trial?
National Institute of Nursing Research (NINR)NIH
580 Previous Clinical Trials
10,376,233 Total Patients Enrolled
34 Trials studying Heart Failure
12,286 Patients Enrolled for Heart Failure
Jia-Rong WuLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have difficulty communicating in English.You have a caregiver who helps with your heart failure care.You don't consistently take your medications as prescribed.I understand and can consent to my treatment.I can be reached by phone.You have another serious illness that cannot be cured.I have a terminal illness or severe kidney disease with less than 1 year to live.I have a caregiver who helps me at least 3 times a week.You have a serious mental illness that causes you to lose touch with reality.I am 18 years old or older.I am willing to undergo treatments with a partner.I have been diagnosed with heart failure.I am willing to involve a care partner in my medication routine.I have participated in a self-care program in the last year.I manage and take my own medications.I have been on stable heart failure medications for over 3 months.You currently have problems with drinking too much alcohol or using drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Care Partners - Attention Only
- Group 2: Patients - FamLit
- Group 3: Patients - Attention Only
- Group 4: Care Partners - FamLit
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.
Are individuals currently being enrolled into this project?
"Confirmed. Clinicaltrials.gov records show that this study, initially posted on December 1st 2022, is not presently recruiting patients. However, there are currently 780 other medical trials across the world attempting to enroll participants at this time."
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