Family-focused Literacy Strategies for Heart Failure

(FamLit_HF Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Jia-Rong Wu

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Jia-Rong Wu

Disqualifiers: Cognitive impairment, Recent hospitalization, Terminal illness, Psychotic illness, Alcohol dependence, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

People with heart failure who do not take their medications as prescribed are at high risk of complications leading to hospitalization, death and poor quality of life. In the proposed intervention, nurses will use easy-to-understand language to coach patients and their care partners to help them work together and build skills to overcome their individual barriers to adherence in order to 1) improve and sustain patient medication adherence; 2) reduce hospitalization; 3) improve quality of life. If effective, this intervention will support long-term medication adherence, thus reducing hospitalizations related to heart failure and quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have been on stable doses of heart failure medications for at least 3 months, suggesting you may need to continue your current medications.

What data supports the effectiveness of the treatment Family-focused Literacy Strategies for Heart Failure?

Research shows that self-management programs for heart failure patients, especially those designed for low literacy levels, can reduce hospitalizations and improve survival rates. Additionally, involving family members in care and improving health literacy can enhance heart failure knowledge and self-care behaviors. ^{1 2 3 4 5}

How is the FamLit treatment different from other heart failure treatments?

The FamLit treatment is unique because it focuses on involving family members and addressing literacy levels to improve self-management and adherence in heart failure patients, unlike traditional treatments that may not consider these aspects. ^{4 6 7 8 9}

Eligibility Criteria

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.

Inclusion Criteria

You have a caregiver who helps with your heart failure care.

You don't consistently take your medications as prescribed.

I can be reached by phone.

Exclusion Criteria

I have difficulty communicating in English.

I understand and can consent to my treatment.

You have another serious illness that cannot be cured.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Initial assessment and randomization of participants into intervention or control groups

1 day

1 visit (in-person)

Intervention

FamLit intervention or attention-control group sessions focusing on medication adherence or general health issues

3 months

1 in-person session, bi-weekly phone boosters

Follow-up

Participants are monitored for medication adherence, hospitalization, and quality of life

12 months

Monthly phone interviews

Treatment Details

Interventions

• Attention Control (Behavioral Intervention)
• FamLit (Behavioral Intervention)

Trial Overview 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.

Participant Groups

Group I: Patients - FamLit Experimental Treatment 1 Intervention

Patients with a confirmed diagnosis of heart failure.

Group II: Care Partners - FamLit Experimental Treatment 1 Intervention

Care partners of patients with a confirmed diagnosis of heart failure.

Group III: Care Partners - Attention Only Active Control 1 Intervention

Care partners of patients with a confirmed diagnosis of heart failure.

Group IV: Patients - Attention Only Active Control 1 Intervention

Patients with a confirmed diagnosis of heart failure.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Jia-Rong Wu Lexington, KY

Who Is Running the Clinical Trial?

Jia-Rong Wu Lead Sponsor

National Institute of Nursing Research (NINR) Collaborator

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Health literacy and adherence to treatment of patients with heart failure. [2020] To relate the level of functional health literacy with adherence and barriers to non-adherence, rehospitalization, readmission and death in patients with heart failure.

2. United States pubmed.ncbi.nlm.nih.gov

Relationship of Health Literacy of Heart Failure Patients and Their Family Members on Heart Failure Knowledge and Self-Care. [2022] We explored the relationships among patients' and family members' (FMs) health literacy, heart failure (HF) knowledge, and self-care behaviors using baseline data from HF patients and their FMs ( N = 113 pairs) in a trial of a self-care intervention. Measures included Rapid Estimate of Adult Literacy in Medicine, Atlanta HF Knowledge Test, a heart failure Medication Adherence Scale, and sodium intake (24-hr urine and 3-day food record). Patients with low health literacy (LHL) were more likely to have lower HF knowledge ( p

3. Ireland pubmed.ncbi.nlm.nih.gov

Development and pilot testing of a disease management program for low literacy patients with heart failure. [2019] Development and pilot testing of a disease management program for low literacy patients with heart failure.

4. England pubmed.ncbi.nlm.nih.gov

A heart failure self-management program for patients of all literacy levels: a randomized, controlled trial [ISRCTN11535170]. [2022] Self-management programs for patients with heart failure can reduce hospitalizations and mortality. However, no programs have analyzed their usefulness for patients with low literacy. We compared the efficacy of a heart failure self-management program designed for patients with low literacy versus usual care.

5. England pubmed.ncbi.nlm.nih.gov

Comparison of a one-time educational intervention to a teach-to-goal educational intervention for self-management of heart failure: design of a randomized controlled trial. [2021] Heart failure (HF) is common, costly and associated with significant morbidity and poor quality of life, particularly for patients with low socioeconomic status. Self-management training has been shown to reduce HF related morbidity and hospitalization rates, but there is uncertainty about how best to deliver such training and what patients benefit. This study compares a single session self-management HF training program against a multiple session training intervention and examines whether their effects differ by literacy level.

6. Spain pubmed.ncbi.nlm.nih.gov

[Protocolo para la evaluación de una intervención de alfabetización en salud sobre morbimortalidad y calidad de vida en pacientes con insuficiencia cardíaca.] [2023] Heart failure (HF) is a complex clinical syndrome that impairs the ability to achieve proper filling or ejection, in which patients have typical symptoms and signs. It is a major Public Health problem with a high incidence and prevalence associated with high morbidity and mortality. The management of the patient with HF is complex, requiring in its treatment the work of specialized multidisciplinary teams in which the management of cardiac-healthy habits and self-care will play a leading role. Knowing the health literacy (HL) level of patients is a fundamental piece that will help us to provide a holistic attention, based on individual needs, promoting in this way the empowerment of the patient. Our aim will be to evaluate the effectiveness of an HL intervention for improving quality of life and decreasing morbidity/mortality.

7. United States pubmed.ncbi.nlm.nih.gov

Relationship between literacy, knowledge, self-care behaviors, and heart failure-related quality of life among patients with heart failure. [2022] We sought to examine the relationship between literacy and heart failure-related quality of life (HFQOL), and to explore whether literacy-related differences in knowledge, self-efficacy and/or self-care behavior explained the relationship.

8. United States pubmed.ncbi.nlm.nih.gov

Family partnership intervention: a guide for a family approach to care of patients with heart failure. [2019] While family focused care is recommended in standards of care for heart failure (HF), little data exist to guide the structure, content, and delivery of family care. The purpose of this article is to describe what is known about the impact of HF, and to examine a family based approach to improve self-management and adherence in HF. A scientific and theoretical background was used to formulate a family based approach to HF care, the Family Partnership Intervention (FPI), and to determine the feasibility and acceptability of the intervention to family members and HF patients. The components of the intervention are described as well as examples of how it was used. Lessons learned in implementing the intervention during a pilot study are addressed.

9. Ireland pubmed.ncbi.nlm.nih.gov

Heart failure family-based education: a systematic review. [2018] To systematically review evidence for the efficacy of family-based education for heart failure (HF) patients and carers.