Family-focused Literacy Strategies for Heart Failure

(FamLit_HF Trial)

Overseen By Jia-Rong Wu, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jia-Rong Wu

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

328 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help people with heart failure adhere to their medication routines. Nurses will use simple language to coach patients and their care partners, aiming to improve medication adherence, reduce hospital visits, and enhance quality of life. The trial involves two groups: one receives the new coaching method called the Family-focused and Literacy-sensitive Intervention (FamLit), and the other receives standard attention. It suits those with heart failure who struggle with taking their medications as prescribed and have someone who regularly assists with their care. As an unphased trial, this study offers a unique opportunity to contribute to innovative strategies that could significantly improve patient care.

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 prior data suggests that this intervention is safe for heart failure patients and their care partners?

Research has shown that health literacy programs, like the one in this trial, are generally safe. Studies suggest that efforts to improve understanding of heart failure and medication use pose no physical risks. Instead, they often help patients manage their conditions better.

Past studies reported no negative effects directly linked to these educational programs. These programs aim to provide simple, clear information to help people take their medicine as prescribed and improve their overall quality of life.

While evidence shows no safety concerns, discussing any questions with the trial team is always a good idea to ensure comfort and understanding. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FamLit approach because it introduces family-focused literacy strategies to support heart failure management. Unlike traditional treatments that primarily involve medication or lifestyle changes, FamLit emphasizes education and communication among patients and their care partners. This method aims to enhance understanding and management of the condition by improving health literacy, which could lead to better adherence to treatment plans and overall outcomes. By involving family members, this approach fosters a supportive environment, potentially reducing hospital readmissions and improving quality of life for patients.

What evidence suggests that this trial's interventions could be effective for heart failure?

Research has shown that the FamLit program, one of the interventions in this trial, emphasizes family involvement and clear communication to help patients with heart failure take their medication more consistently. Studies have found that patients in such programs develop better medication-taking habits. This is crucial because adhering to prescribed medication can reduce hospital visits and enhance the quality of life for heart failure patients. By involving family members and using simple language, the program aids patients in following their medication plans more reliably. This approach has shown promise in supporting long-term medication use and reducing heart failure complications. Meanwhile, the trial will evaluate the Attention Control intervention, another arm of this study, for its comparative effectiveness. ^{6 7 8 9 10}

Who Is on the Research Team?

Jia-Rong Wu

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Attention Control
• FamLit

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.

How Is the Trial Designed?

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.

Who Is Running the Clinical Trial?

Jia-Rong Wu

Lead Sponsor

Trials

1

Recruited

330+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

The Family Partnership Intervention (FPI) was developed to enhance self-management and adherence in heart failure patients by involving their families in the care process, addressing a gap in existing heart failure care standards.

A pilot study was conducted to assess the feasibility and acceptability of the FPI among family members and heart failure patients, providing insights into effective family-based approaches for managing heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family partnership intervention: a guide for a family approach to care of patients with heart failure. Clark, PC., Dunbar, SB.[2019]

The study aims to evaluate the effectiveness of a health literacy (HL) intervention in improving the quality of life and reducing morbidity and mortality in heart failure patients, highlighting the importance of patient empowerment in managing this complex condition.

This research will be conducted as a two-arm randomized controlled trial across five hospitals in Spain, focusing on patients diagnosed with heart failure, which underscores the need for tailored interventions based on individual health literacy levels.

NCBI (Pubmed)

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.] Mancebo-Salas, N., Cobo-Sánchez, JL., Arroyo-Toca, B., et al.[2023]

Patients with low health literacy (LHL) had significantly lower heart failure (HF) knowledge, which was associated with poorer medication adherence and higher sodium intake, indicating a potential risk for worse health outcomes.

When both patients and their family members had low health literacy, the lowest levels of HF knowledge and medication adherence were observed, suggesting that improving health literacy in both groups is crucial for effective self-care interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship of Health Literacy of Heart Failure Patients and Their Family Members on Heart Failure Knowledge and Self-Care. Wu, JR., Reilly, CM., Holland, J., et al.[2022]

Family-based education for heart failure patients and their carers can significantly improve knowledge about heart failure, as well as enhance self-care behaviors and adherence to dietary and treatment plans, based on a systematic review of six trials.

While there were positive outcomes in patient quality of life and reduced carer burden, the overall evidence is modest and highlights the need for more rigorous future research to strengthen these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart failure family-based education: a systematic review. Srisuk, N., Cameron, J., Ski, CF., et al.[2018]

A disease management program tailored for low literacy patients with heart failure was found to be acceptable and led to significant improvements in self-care behaviors, such as daily weight monitoring, increasing from 32% to 100% participation.

Although patients' heart failure knowledge did not improve, there was a notable reduction in heart failure-related symptoms, with an average improvement of 9.9 points on the Minnesota Living with Heart Failure scale over three months, indicating better overall health status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and pilot testing of a disease management program for low literacy patients with heart failure. DeWalt, DA., Pignone, M., Malone, R., et al.[2019]

In a study of 605 heart failure patients, those with adequate literacy levels reported significantly better heart failure-related quality of life (HFQOL) scores compared to those with low literacy, indicating that literacy impacts health outcomes.

While patients with higher literacy had better knowledge, self-efficacy, and self-care behaviors related to heart failure, these factors did not explain the link between low literacy and poorer HFQOL, suggesting that other unmeasured factors may contribute to this relationship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between literacy, knowledge, self-care behaviors, and heart failure-related quality of life among patients with heart failure. Macabasco-O'Connell, A., DeWalt, DA., Broucksou, KA., et al.[2022]

A heart failure self-management program tailored for patients with low literacy significantly reduced the risk of hospitalizations or death, with an adjusted incidence rate ratio of 0.53, indicating a strong efficacy in this population.

The program improved daily weight monitoring among participants, with 79% of intervention patients reporting this practice compared to only 29% in the control group, highlighting the program's effectiveness in promoting self-care behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A heart failure self-management program for patients of all literacy levels: a randomized, controlled trial [ISRCTN11535170]. DeWalt, DA., Malone, RM., Bryant, ME., et al.[2022]

In a study of 100 heart failure patients, low functional health literacy was linked to poor medication adherence, with 41.1% of participants not following their treatment plans, and 55.9% of these individuals having inadequate literacy.

Patients with inadequate literacy faced higher rates of rehospitalization and death, indicating that improving health literacy could be crucial for better health outcomes in heart failure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health literacy and adherence to treatment of patients with heart failure. Oscalices, MIL., Okuno, MFP., Lopes, MCBT., et al.[2020]

This study is evaluating the effectiveness of a single-session versus a multiple-session self-management training program for heart failure patients, focusing on how these interventions impact hospitalization and mortality rates, particularly among patients with varying literacy levels.

The trial involves 660 participants with heart failure symptoms, and aims to determine which training method is more beneficial for improving self-care behaviors and quality of life, while also addressing the specific needs of patients with low literacy.

NCBI (Pubmed)

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. DeWalt, DA., Broucksou, KA., Hawk, V., et al.[2021]

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