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

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}

Research Team

Jia-Rong Wu

Principal Investigator

University of Kentucky

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.

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
• 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.

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.

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Health literacy and adherence to treatment of patients with heart failure. [2020]

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]

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

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

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]

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]

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]

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]

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]

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

Heart failure family-based education: a systematic review. [2018]