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Phone Intervention for Heart Failure

N/A

Recruiting

Led By Christopher M Celano, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult patients with NYHA class I, II, or III HF.

Be older than 18 years old

Must not have

Inability to read, write, or speak in English.

Cognitive deficits impeding a participant's ability to provide informed consent or participate, assessed via a 6-item cognitive test.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up throughout study period (estimated mean duration 28 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a 12-week phone intervention to see if it is better than an educational intervention at improving heart health for people with heart failure.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the interventions involve psychological support and education rather than medication, typical medical side effects are not expected. However, participants may experience emotional discomfort or stress during counseling sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot read, write, or speak English.

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I can understand and make decisions about my health care.

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I cannot be physically active due to a condition like arthritis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout study period (estimated mean duration 28 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~throughout study period (estimated mean duration 28 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout study period (estimated mean duration 28 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Health behavior adherence

Secondary study objectives

Objective medication adherence (Medication Event Monitoring System [MEMS] pill bottles)

Physical Function (PROMIS 20-item Physical Function Short Form [PF-20])

Physical activity (in steps/day)

+2 more

Other study objectives

6-minute walk test (in meters traveled)

All-cause Hospitalizations

Anxiety (Hospital Anxiety and Depression Scale - anxiety subscale [HADS-A])

+20 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PP-MI InterventionExperimental Treatment1 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 InterventionActive Control1 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).

0 / 4Eligibility criteria met