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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
Must not have
Non-English speaking or any other communication barrier
Cognitive impairment affecting understanding and giving informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with heart failure.
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I manage and take my own medications.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have difficulty communicating in English.
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I understand and can consent to my treatment.
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I have a terminal illness or severe kidney disease with less than 1 year to live.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Medication adherence
Self-reported medication adherence.
Secondary study objectives
Patient hospitalization
Positive Affect
Quality of life - Minnesota Living with Heart Failure
Other study objectives
Caregiver Burden
Communication
Health Literacy
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
606 Previous Clinical Trials
10,378,388 Total Patients Enrolled
34 Trials studying Heart Failure
12,286 Patients Enrolled for Heart Failure
Jia-Rong WuLead Sponsor

Media Library

FamLit Clinical Trial Eligibility Overview. Trial Name: NCT05548413 — N/A
Heart Failure Research Study Groups: Care Partners - Attention Only, Patients - FamLit, Patients - Attention Only, Care Partners - FamLit
Heart Failure Clinical Trial 2023: FamLit Highlights & Side Effects. Trial Name: NCT05548413 — N/A
FamLit 2023 Treatment Timeline for Medical Study. Trial Name: NCT05548413 — N/A
~186 spots leftby Jun 2027
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