Values-Affirmation + Education for Heart Failure

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Miriam Hospital

Disqualifiers: Class IV heart failure, Alzheimer's, dementia, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a values affirmation approach can help people with heart failure adhere better to their medication routine. Participants will receive either this special support along with their usual care or just the usual care. The trial seeks individuals who have heart failure, are currently in cardiac rehab, and can read and understand English. By testing the feasibility and acceptability of this method, the trial aims to discover better ways to support heart failure patients in managing their health. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative approaches in heart failure care.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this values affirmation intervention is safe for adults with heart failure?

Research shows that activities like the one under study, called values affirmation, can lead to positive outcomes, such as increased patient involvement in their own care. However, existing studies do not specifically address the safety of this values affirmation activity. Since it does not involve medication, it is generally considered safe. There are no reports of physical side effects, as it focuses on personal reflection rather than medication. Prospective participants should discuss any concerns with the research team or their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Values Affirmation approach for heart failure because it offers a unique, psychological twist to traditional care. Unlike standard treatments that focus solely on medications or lifestyle changes, this method encourages patients to reflect on their personal values, which can enhance motivation and adherence to their care plan. By integrating personal values with usual care, this technique aims to improve both mental and physical health outcomes, offering a more holistic approach to managing heart failure.

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

This trial will compare the effectiveness of two approaches for heart failure management: Values Affirmation combined with Usual Care, and Usual Care alone. Research has shown that reflecting on personal values can help people with heart failure adhere to their medication regimens. Studies have found that this method, known as values affirmation, can boost motivation and consistency in taking medication. Additionally, educating patients is crucial for managing heart failure, as it helps them understand their condition and treatment. Education programs have successfully improved health outcomes for heart failure patients. Together, these approaches aim to enhance medication adherence and overall health. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for older adults with heart failure who are currently enrolled in cardiac rehabilitation and can read and understand English. It's not open to those with the most severe heart failure (NYHA class IV), Alzheimer's, dementia, severe cognitive impairment, current suicidality or psychosis, or those already in another medication-monitoring study.

Inclusion Criteria

I am currently enrolled in a cardiac rehabilitation program.

Patients who can read and understand English

I have heart failure.

Exclusion Criteria

Current participation in another medication-monitoring clinical or research protocol

I have the most severe form of heart failure.

You have been diagnosed with Alzheimer's, dementia, or severe memory problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a baseline assessment including 30 days of medication monitoring using electronic medication monitoring devices

4 weeks

Intervention

Participants in the intervention group complete a values-affirmation intervention with tailored education, while control participants continue with usual care

4 weeks

Follow-up

Participants are monitored for changes in medication adherence and other outcomes post-intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Usual Care
• Values Affirmation

Trial Overview The study is testing a new approach called 'Values Affirmation' combined with usual care against just usual care alone. The aim is to see if this intervention helps patients stick to their heart medication better during cardiac rehab.

How Is the Trial Designed?

Group I: Values Affirmation + Usual Care Experimental Treatment 1 Intervention

Group II: Usual Care Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

The Miriam Hospital

Lead Sponsor

Trials

252

Recruited

39,200+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

A study involving 12 heart failure patients revealed that their personal values significantly influence their self-care decisions and adherence, highlighting the importance of understanding these values in managing heart failure.

Patients often face conflicts between their values and their physical abilities, leading to nonadherence in self-care; therefore, supporting patients in finding alternative ways to align their self-care with their values is crucial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Views of Patients With Heart Failure on Their Value-Based Self-care Decisions: A Qualitative Study. Karimi-Dehkordi, M., Clark, AM.[2021]

A review of 19 randomized controlled trials on therapeutic patient education for heart failure revealed that while major elements of program descriptions were present, critical information such as patients' educational needs and evaluation methods were often missing.

Improving the precision of program descriptions in future studies could enhance the effectiveness of therapeutic patient education for heart failure patients, suggesting a need for standardized reporting formats.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic patient education in heart failure: do studies provide sufficient information about the educational programme? Albano, MG., Jourdain, P., De Andrade, V., et al.[2014]

A study evaluating 39 online educational resources about heart failure medications found that most had acceptable quality, with a median score of 61% on the EQIP tool, but only 5% were rated as high quality.

The readability of these resources was generally too high for many patients, with a median grade level of 8, while only 10% met the recommended 6th-grade reading level, which could hinder understanding for those with lower literacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Online Written Medication Educational Resources for People Living With Heart Failure. Ladhar, S., Koshman, SL., Yang, F., et al.[2022]

Patient education about heart failure and its treatment is crucial for improving compliance, which directly impacts prognosis.

Implementing therapeutic education in community hospitals can enhance patient knowledge and involvement, leading to reduced hospitalization duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Educating patients about heart failure in community hospitals: it is possible...]. Jourdain, P., Funck, F., Bellorini, M., et al.[2017]

In a study of 495 heart failure patients, 67% reported experiencing adverse drug events (ADEs) in the past month, with common symptoms including dry mouth and dizziness.

Patients who believed they had more disease symptoms and held negative beliefs about their medications were at a higher risk of experiencing ADEs, suggesting that addressing these perceptions could improve patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-reported adverse drug events and the role of illness perception and medication beliefs in ambulatory heart failure patients: A cross-sectional survey. De Smedt, RH., Denig, P., van der Meer, K., et al.[2011]

A study found that heart failure patients generally lack essential knowledge for effective self-care, particularly regarding medications, weight monitoring, and understanding heart failure itself.

Despite older age and higher education correlating with better knowledge, overall awareness was low across all demographics, highlighting the need for innovative educational strategies by healthcare providers to improve patient self-care and health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What do patients know about their heart failure? Artinian, NT., Magnan, M., Christian, W., et al.[2021]

A structured heart failure education program significantly improved patients' knowledge about their condition and enhanced their self-management skills compared to a single lecture, as shown in a randomized controlled trial.

Both the education and control groups experienced improvements in disease status during rehabilitation, but those in the education program maintained better medication adherence and more frequently documented their self-tests six months later.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Patient education in heart failure improves disease-related knowledge and behavior during cardiac rehabilitation]. Glatz, J., Muschalla, B., Karger, G.[2014]

Empowering patients with heart failure involves providing education and support to help them understand their condition and engage in their care.

Improving patient-provider communication and shared decision-making is essential for enhancing the care delivery systems for individuals living with heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empowering People Living with Heart Failure. Wohlfahrt, P., Stehlik, J., Pan, IZ., et al.[2021]

In a study of 261 heart failure patients, common adverse drug events (ADEs) included dizziness (26%) and dry mouth (24%), with nearly half of the patients perceiving these ADEs as serious and significantly impacting their daily lives.

Patients expressed a strong belief in healthcare providers' ability to manage ADEs, but many felt that these issues were chronic and caused emotional distress, highlighting the need for better communication between patients and providers regarding ADE management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived adverse drug events in heart failure: patients' perception and related factors. De Smedt, RH., Haaijer-Ruskamp, FM., Groenier, KH., et al.[2011]

In a study of 38 individuals with varying levels of heart failure, therapeutic value emerged as the most significant factor influencing self-management decision making, highlighting its importance in patient care.

As heart failure progressed, patients experienced fewer decision influences, particularly regarding task difficulty, suggesting that more advanced stages of the disease may simplify decision-making processes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management decision influences in heart failure: a preliminary investigation. Hicks, FD., Holm, K.[2017]

A heart failure education class significantly reduced hospital admissions and emergency department visits for patients, with a decrease from 96% to 35% in the 90 days following the class compared to the 90 days prior (p < 0.01).

Participants reported increased confidence and improved self-management skills in handling their heart failure, suggesting that educational interventions can enhance patient quality of life and potentially lower healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a heart failure educational intervention for patients with recent admissions for acute decompensated heart failure. Stahlman, S., Huizar-Garcia, S., Lipscomb, J., et al.[2023]

In a study of 133 heart failure patients, 83% reported that their knowledge expectations regarding device implantation were not met, highlighting a significant gap in patient education.

Key factors influencing whether patients' knowledge expectations were fulfilled included access to information from healthcare professionals, educational level, and the patients' own expectations, suggesting that improved communication and tailored educational approaches could enhance patient understanding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients are expecting to learn more: A longitudinal study of patients with heart failure undergoing device implantation. Ingadottir, B., Thylén, I., Ulin, K., et al.[2021]

A study of 80 patients with chronic heart failure showed that care based on the Ottawa Decision Support Framework significantly reduced anxiety levels and improved treatment compliance after three months of nursing care.

The framework also led to a notable improvement in self-care abilities and quality of life, while maintaining a low complication rate of 2.5% and a readmission rate of 2.75%, indicating its effectiveness in managing chronic heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Ottawa Decision-Making Supportive Framework-Based Nursing Care in the Outcome of Patients with Chronic Heart Failure. Teng, Y., Liu, T., Li, X., et al.[2023]

A study involving 152 heart failure patients showed that guided education using a specific questionnaire significantly improved patients' knowledge scores from 59% to 78.5%, which was linked to better self-care and a trend towards improved quality of life.

Patients receiving guided education had a lower rate of death or hospital admissions (13.6%) compared to those receiving standard education (29.7%), indicating that tailored educational interventions can lead to better health outcomes in heart failure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a heart failure knowledge questionnaire and its use in guiding the educational intervention. Sánchez-Ramos, JG., Lerma-Barba, MD., Segura-Rodríguez, D., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05310877

Values-Affirmation Intervention Targeting Medication ... Values-Affirmation Intervention Targeting Medication Adherence in Older Adults With Heart Failure · Study Overview · Contacts and Locations · Participation ...

2. withpower.com withpower.com/trial/phase-heart-failure-8-2022-0421f

Values-Affirmation + Education for Heart Failure Additionally, patient education is highlighted as a crucial part of heart failure therapy, aiming to enhance self-management and improve the disease's ...

3. reporter.nih.gov reporter.nih.gov/search/Fy6cHdAzCUycPtSqWPe6CA/project-details/10617355

Development of a Values-Affirmation Intervention ... - NIH RePORTER This application proposes to develop a novel values-affirmation intervention to improve medication adherence in HF patients enrolled in cardiac rehabilitation.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11057052/

A clinical study of heart failure education intervention - PMC Heart failure education intervention demonstrates effectiveness in improving the therapeutic outcomes for HF patients and reduced nonvalvular ejection fraction.

5. ahajournals.org ahajournals.org/doi/10.1161/hcq.0000000000000025

Evidence for Therapeutic Patient Education Interventions to ... AF indicates atrial fibrillation; CVD, cardiovascular disease; HF, heart failure; and TPE, therapeutic patient education. Evidence Findings.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8678693/

Effect of Values Affirmation on Reducing Racial Differences in ... A values affirmation intervention was associated with higher patient activation overall but did not improve adherence or blood pressure among ...

7. smartpatients.com smartpatients.com/trials/NCT05575375

Values-Affirmation + Education Intervention Targeting ... The goals of this study are to determine the (1) feasibility and (2) acceptability of the study procedures through a pilot randomized controlled trial of a ...

8. reporter.nih.gov reporter.nih.gov/project-details/11063200

golbus, jessica rachel - NIH RePORTER Development of a Values-Affirmation Intervention Targeting Medication Adherence in Older Adults with Heart Failure Completing Cardiac Rehabilitation. 323 ...