Phone Intervention for Heart Failure

Overseen By Christohper M Celano, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Cognitive deficits, Terminal illness, Physical activity limitations, others

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

Compensation: Varies

Number of Visits: 74

Duration: 12 weeks

280 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a phone-based program using Positive Psychology and Motivational Interviewing (PP-MI Intervention) can help individuals with certain types of heart failure improve their health habits. Participants will receive weekly phone sessions and texts for support. The study will compare this method to a similar program focusing solely on education about heart failure. Suitable candidates have heart failure impacting their daily life and face challenges in maintaining health routines like diet and exercise. As an unphased trial, this study provides a unique opportunity to explore innovative methods for enhancing heart health routines.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on phone-based interventions and text messages for heart failure patients.

What prior data suggests that this phone intervention is safe for heart failure patients?

Research has shown that the Positive Psychology-Motivational Interviewing (PP-MI) approach is generally safe for people with heart failure. Studies have found that this method improves health habits and overall well-being without causing serious side effects. Patients engage in activities that promote positive thinking and motivation to enhance heart health.

Motivational interviewing alone has also proven effective in improving self-care for heart failure patients. This technique encourages patients to maintain healthy routines, and research indicates it is well-tolerated with no major side effects reported.

Both treatments focus on providing psychological support and education, which are considered safe and helpful. While detailed information on side effects is limited, previous studies suggest these methods are unlikely to cause harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PP-MI intervention for heart failure because it combines Positive Psychology and Motivational Interviewing in a way that is new for this condition. Unlike traditional treatments that focus primarily on medication and lifestyle changes, this approach emphasizes mental well-being and motivation, helping patients set and achieve health goals through guided phone sessions. Additionally, the intervention includes consistent support through supplemental text messages, ensuring continuous engagement and adherence, which could lead to better overall outcomes for heart failure patients.

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

Research has shown that the Positive Psychology-Motivational Interviewing (PP-MI) approach, one of the interventions in this trial, can significantly help patients maintain healthy habits and manage their heart health. By combining positive thinking exercises with motivational conversations, individuals with heart failure adhere better to their treatment plans, potentially improving heart health.

The MI-alone intervention, another treatment arm in this trial, also proves beneficial. It aids patients with heart failure in managing symptoms and adhering to self-care routines. Evidence suggests that MI can enhance patients' quality of life by encouraging better self-care. Both methods show promise in helping patients manage heart failure more effectively. ^{1 2 6 7 8}

Who Is on the Research Team?

Christopher Celano, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults with mild to moderate Heart Failure (NYHA class I-III) who aren't sticking well to health behaviors like diet, exercise, or taking medications. It's not for those with severe cognitive issues, life-threatening conditions, language barriers in English, physical activity limitations due to other illnesses, or if they're already in a similar program.

Inclusion Criteria

I have heart failure but can still perform daily activities with little to moderate difficulty.

You do not follow recommended diet, exercise, or medication instructions well, as shown by a low score on a specific questionnaire.

Exclusion Criteria

You have a medical condition that is likely to cause death within the next 6 months.

I cannot read, write, or speak English.

I can understand and make decisions about my health care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

2 visits (in-person or virtual)

Treatment

Participants receive a 12-week, phone-delivered Positive Psychology-Motivational Interviewing (PP-MI) intervention with weekly phone sessions and twice weekly text messages

12 weeks

12 phone sessions

Initial Follow-up

Participants continue to receive twice weekly text messages and are monitored for health behavior adherence and psychological outcomes

12 weeks

Follow-up visits at 12 and 24 weeks

Extended Follow-up

Participants are monitored for long-term outcomes including cardiovascular health and hospitalizations

24 weeks

Follow-up visits at 48 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MI-alone Intervention
• PP-MI Intervention

Trial Overview

The study tests a 12-week phone-delivered Positive Psychology-Motivational Interviewing (PP-MI) intervention with supportive texts over 24 weeks against an educational program using Motivational Interviewing alone. The goal is to see which method better promotes well-being and health behavior adherence in heart failure patients.

How Is the Trial Designed?

Group I: PP-MI Intervention Experimental Treatment 1 Intervention

Participants will receive a 12-week, Positive Psychology-Motivational Interviewing (PP-MI) intervention. Each week, participants will complete a PP activity and work towards one or more health behavior goals, then complete a phone session with a study trainer. Each weekly session will include PP and goal setting portions. In the PP portion, a study trainer will (a) review the week's PP exercise, (b) discuss the rationale of the next week's PP exercise through a guided review of the PP-MI manual, and (c) assign the next week's PP exercise. Additionally for the goal-setting portion, the trainer will (a) review their goals and health behaviors from the prior week, (b) discuss techniques for improving health behavior adherence (e.g., monitoring physical activity, reading nutrition labels), and (c) set goals for the next week. Finally, participants will receive supplemental text messages throughout the 12 weeks of the intervention and during the initial follow-up period (Week 13-24).

Group II: MI-alone Intervention Active Control 1 Intervention

This condition will mirror the MI component of the PP-MI intervention. During the first three sessions, participants will learn about the causes and types of HF, risk factors for cardiovascular disease, and methods for monitoring risk factors and symptoms. Then participants will complete nine sessions related to physical activity, a low sodium diet, and medication adherence. Weekly tasks (e.g., brainstorming barriers) will be assigned, completed between calls, and reviewed at the following call. Finally, participants will receive supplemental text messages throughout the 12 weeks of the intervention and during the initial follow-up period (Week 13-24).

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

Motivational interviewing (MI) has been shown to positively impact self-care outcomes for heart failure patients, making it a valuable tool in both hospital and clinic settings.

MI techniques, which include open-ended questions and reflective listening, can be effectively applied even in brief interactions, and clinicians are encouraged to seek feedback to enhance their MI skills for better patient support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Evidence-Based Motivational Interviewing Strategies in the Care of Patients with Heart Failure. Judice Jones, N., Richard, A.[2022]

An 8-week phone-based positive psychology intervention was developed for patients hospitalized with acute cardiac conditions, focusing on exercises related to optimism, kindness, and gratitude.

A small pilot trial indicated that this intervention was feasible and well-accepted among patients, suggesting potential for improving psychological well-being in cardiac patients, which could lead to better cardiovascular outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a positive psychology intervention for patients with acute cardiovascular disease. Huffman, JC., Mastromauro, CA., Boehm, JK., et al.[2022]

A 2-day virtual training program in motivational interviewing (MI) for 30 clinicians from Veterans Affairs medical centers was effective, with participants reporting high satisfaction and confidence in applying new skills to their practice.

The virtual format of the training removed barriers such as travel and cost, making it particularly beneficial for clinicians in rural areas, and participants indicated they were actively using MI techniques three months after the training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Synchronous Motivational Interviewing Training for Geographically Dispersed Interprofessional Learners. Bryan, JL., Saxon, LC., Mesidor, MM., et al.[2023]

The MITI-HF study is testing a nurse-led motivational interviewing intervention over 90 days to improve self-care in heart failure patients, addressing behavioral and motivational challenges.

The primary goal is to measure changes in self-care maintenance, with the expectation that motivational interviewing will enhance patients' internal motivation and ability to manage their health effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational Interviewing Tailored Interventions for Heart Failure (MITI-HF): study design and methods. Masterson Creber, R., Patey, M., Dickson, VV., et al.[2018]

In a study of 230 heart failure patients, those with nonischemic heart failure and fewer medications were identified as less likely to benefit from motivational interviewing (MI) for improving self-care, indicating a need for alternative treatments for these individuals.

Patients living alone and those with higher baseline self-care management were also at risk for not responding to MI, suggesting that personal circumstances and initial self-care levels should be considered when tailoring interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of Patients Who Do Not Respond to Motivational Interviewing for Heart Failure Self-care. Stawnychy, MA., Zeffiro, V., Iovino, P., et al.[2022]

A randomized controlled trial involving 21 patients with implantable cardioverter defibrillators (ICDs) showed that a positive psychology intervention (Quality of Life Therapy) was feasible and well-accepted, with 71% attendance and 80% completion of homework assignments.

Participants in the Quality of Life Therapy group found their sessions significantly more helpful compared to those in the Heart Healthy Education group, suggesting that positive psychological approaches may enhance the well-being of ICD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation, feasibility, and acceptability of quality of life therapy to improve positive emotions among patients with implantable cardioverter defibrillators. Carroll, AJ., Christon, LM., Rodrigue, JR., et al.[2021]

The Web-based e-learning platform for brief motivational interviewing (MOTIV@CŒUR) was found to be feasible and highly acceptable among cardiovascular care nurses, with 77% completing the training within the designated time frame.

Post-training assessments showed a significant increase in nurses' self-reported clinical use of confidence interventions, indicating that the training effectively enhanced their perceived skills in brief motivational interviewing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Web-Based E-Learning Platform for Brief Motivational Interviewing by Nurses in Cardiovascular Care: A Pilot Study. Fontaine, G., Cossette, S., Heppell, S., et al.[2018]

Motivational interviewing (MI) is an effective communication technique that helps patients engage in discussions about changing their health behaviors by addressing their ambivalence.

MI practitioners use specific skills and strategies to create a gap between a patient's current behaviors and their personal goals, facilitating a more productive conversation about health changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivating Behavioral Change. Tooley, EM., Kolahi, A.[2022]

Motivational interviewing (MI) techniques, such as reflection, genuine empathy, and individualized problem solving, were found to significantly improve self-care in heart failure patients by fostering openness to goal setting and enhancing self-efficacy.

The study identified that the effectiveness of MI in promoting behavioral change is linked to the development of discrepancy and self-efficacy, which are key principles of MI, suggesting that these techniques can effectively engage patients in their self-care management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanisms of change in self-care in adults with heart failure receiving a tailored, motivational interviewing intervention. Riegel, B., Dickson, VV., Garcia, LE., et al.[2019]

This study will evaluate the effectiveness of motivational interviewing (MI) in improving self-care maintenance among 240 heart failure patients and their caregivers, with outcomes assessed at multiple time points up to 12 months.

The trial will compare MI interventions for patients only versus both patients and caregivers against standard care, aiming to determine if involving caregivers enhances self-care and overall patient outcomes, which is crucial given the rising prevalence of heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MOTIVATional intErviewing to improve self-care in Heart Failure patients (MOTIVATE-HF): Study protocol of a three-arm multicenter randomized controlled trial. Vellone, E., Paturzo, M., D'Agostino, F., et al.[2018]

Over 70% of the 186 surveyed Physician Assistant (PA) programs in the U.S. include at least one course on motivational interviewing (MI), indicating a recognition of its importance in helping patients change health behaviors.

Despite the inclusion of MI training, many programs lack comprehensive instruction on key aspects like 'change talk,' and underutilize effective teaching methods such as role-play and standardized patient exercises, suggesting areas for improvement in PA education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Motivational Interviewing in the Physician Assistant Curriculum. Halbach, P., Keller, AO.[2019]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4733398/

Motivational interviewing to improve self-care for patients ...

Abbreviations: SD: standard deviation; HFSPS: heart failure somatic perception scale; KCCQ: Kansas City Cardiomyopathy Questionnaire, QOL: quality of life, CSS: ...

2.

researchprotocols.org

researchprotocols.org/2023/1/e44629/

Motivational Interviewing for Enhancing Self-care in ...

Effectiveness of nurse-led heart failure self-care education on health outcomes of heart failure patients: a systematic review and meta-analysis ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0885392421005327

A Motivational Interviewing Intervention Improves Physical ...

Heart failure (HF) patients experience high burden of physical symptoms during their disease trajectory. Objective. To evaluate the effects of Motivational ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02894502

MOTIVATional intErviewing to Improve Self-care in Heart ...

The aims of this study will be to evaluate the effect of motivational interviewing (MI) to improve self-care in heart failure (HF) patients and caregiver ...

5.

journals.lww.com

journals.lww.com/jcnjournal/fulltext/2024/03000/the_effectiveness_of_a_motivational_interviewing.3.aspx

The Effectiveness of a Motivational Interviewing...

The Effectiveness of a Motivational Interviewing Intervention on Mutuality Between Patients With Heart Failure and Their Caregivers. A Secondary Outcome ...

6.

link.springer.com

link.springer.com/article/10.1007/s40271-019-00387-6

Motivational Interviewing as a Strategy to Impact Outcomes ...

Motivational Interviewing as a Strategy to Impact Outcomes in Heart Failure Patients: A Systematic Review. Systematic Review; Published: 10 ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02177656

Motivational Interviewing Tailored Intervention for Patients ...

Quality of Life will be measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ), a 23-item questionnaire that quantifies disease- ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4386995/

MOTIVATIONAL INTERVIEWING TAILORED ...

Primary Outcome: Self Care of Heart Failure Index · Secondary Outcome: Kansas City Cardiomyopathy Questionnaire (KCCQ) · Heart Failure Somatic Perception Scale ( ...