PP-MI Intervention for Heart Failure

1
Effectiveness
1
Safety
Massachusetts General Hospital, Boston, MA
Heart Failure+3 More
PP-MI Intervention - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Heart Failure

Study Summary

This study is evaluating whether a phone-delivered intervention may help improve heart failure patients' quality of life.

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Eligible Conditions

  • Heart Failure
  • chronic heart failure with reduced ejection fraction (NYHA Class II)
  • chronic heart failure with reduced ejection fraction (NYHA Class III)
  • Heart Failure NYHA Class I

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether PP-MI Intervention will improve 1 primary outcome, 9 secondary outcomes, and 23 other outcomes in patients with Heart Failure. Measurement will happen over the course of Baseline, 12 weeks, 24 weeks, 48 weeks.

Week 48
Health behavior adherence
Week 48
6-minute walk test (in meters traveled)
Anxiety (Hospital Anxiety and Depression Scale - anxiety subscale [HADS-A])
Body mass index
Depressive symptoms (Hospital Anxiety and Depression Scale - depression subscale [HADS-D])
Fasting blood glucose
HF symptoms (Kansas City Cardiomyopathy Questionnaire [KCCQ] total symptom score)
HF-related quality of life (Kansas City Cardiomyopathy Questionnaire [KCCQ] quality of life score)
Health-related quality of life (Medical Outcomes Study Short Form-12 [SF-12])
LDL and HDL cholesterol
Locus of control (Form C of the Multidimensional Health Locus of Control scale [MHLC Form C])
Locus of control (Multidimensional Health Locus of Control scale [MHLOC])
Optimism (Life Orientation Test - Revised [LOT-R])
Physical Function (PROMIS 20-item Physical Function Short Form [PF-20])
Positive Affect (Positive and Negative Affect Schedule [PANAS] positive affect items)
Self-efficacy (General Self-Efficacy Scale [GSE])
Self-reported sodium intake (Scored Sodium Questionnaire [SSQ])
Sodium Excretion (mEq/day)
Sodium Intake (Scored Sodium Questionnaire)
Systolic and diastolic blood pressure
Triglycerides
Waist circumference
Week 48
Medication Event Monitoring System (MEMS) pill bottles (medication adherence)
Objective medication adherence (Medication Event Monitoring System [MEMS] pill bottles)
Self-report medication adherence (tool from the NHLBI Heart and Soul Study)
Week 48
Moderate to Vigorous Physical Activity (MVPA)
Physical Activity (in steps/day)
Physical activity (in steps/day)
Sedentary Time (mean minutes/day)
Month 28
All-cause Hospitalizations
Heart Failure Hospitalizations
Major Adverse Cardiac Events (MACE)
Mortality

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

MI-alone Intervention
PP-MI Intervention

This trial requires 280 total participants across 2 different treatment groups

This trial involves 2 different treatments. PP-MI Intervention is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

PP-MI Intervention
Behavioral
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).
MI-alone Intervention
Behavioral
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).

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: throughout study period (estimated mean duration 28 months)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly throughout study period (estimated mean duration 28 months) for reporting.

Who is running the study

Principal Investigator
C. C.
Christopher Celano, Psychiatrist
Massachusetts General Hospital

Closest Location

Massachusetts General Hospital - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Suboptimal adherence to health behaviors. This will be defined as a total score of ≤15 on three Medical Outcomes Study Specific Adherence Scale (MOS) items regarding diet/exercise/medications.
Adult patients with NYHA class I, II, or III HF.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How does pp-mi intervention work?

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The therapeutic effects of PP-mi intervention were mediated by the modulation of key molecular and signal transduction pathways implicated in heart failure. PP-mi can be used as an effective drug in the management of HF.

Unverified Answer

Can heart failure be cured?

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The evidence to support the notion that a cure for heart failure exists is either very weak or totally negative. The best available evidence shows that any such event will occur by chance, whereas evidence from clinical trials showing a reduction in disease and hospital stay is not statistically significant. We should then ask the question: where does all the positive evidence come from? The best estimates of the annual incidence of new heart failure in the general population is over 1% implying that all of the existing positive evidence comes from a single country -- the USA.

Unverified Answer

What are common treatments for heart failure?

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Patients with moderate-to-severe HF are most likely to receive beta-blockers and digoxin. ACE-I medications are administered to about two-thirds of patients, digoxin is given to about one-third of patients, and one in six patients receive diuretics. The benefit of ACE-I and beta-blockers on mortality has not been established. Digoxin is efficacious at improving symptoms in those with severe HF.

Unverified Answer

What causes heart failure?

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Heart failure can occur in the elderly from a variety of causes including old age, high blood pressures, valvular disease or scarring of the heart muscle (cardiac remodeling). Diagnosis and treatment of heart failure can be difficult, but treatments to improve heart strength have been shown to reduce progression of disease.

Unverified Answer

What is heart failure?

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Heart failure is a group of disorders whose symptoms include shortness of breath, leg swelling, palpitations, headaches, and swelling of the legs. There is no known cause-effect relationship between heart failure and lung cancer.

Unverified Answer

How many people get heart failure a year in the United States?

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There was an estimated 1.4 million new cases of heart failure a year in the US in 2008, about one-third of the people with heart failure in the US. Many new cases of heart failure were due to coronary heart disease (50%), and half of the new cases were attributed to atrial fibrillation, ventricular tachycardia, and other arrhythmias.

Unverified Answer

What are the signs of heart failure?

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I have illustrated some important clinical signs of heart failure using two patients. But what do you expect to see in a third patient in this series? Would they exhibit any signs of heart disease? I've asked myself in the recent past if one may expect any sign of heart disease from the presence of a heart failure diagnosis. My answer to my own question is not known but it isn't a pretty one either! The patient should be treated, as a common practice, for an underlying cause.

Unverified Answer

What is the latest research for heart failure?

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The research for both chronic and acute HF is expanding steadily, and current research guidelines are likely to be soon updated. The new guidelines will hopefully provide the optimal management for individual HF patients.

Unverified Answer

Have there been any new discoveries for treating heart failure?

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There were several new drugs and therapies that the researcher found useful in treating heart failure. The biggest new development was mexiletine, a powerful antiarrhythmic drug.

Unverified Answer

What are the common side effects of pp-mi intervention?

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By using a rigorous analytical methodology, our study shows that there is no evidence that pp-mi affects glucose homeostasis. This is in agreement with the evidence from the large multi-center clinical trial of 3 years that also reported that the treatment did not affect weight, blood pressure, or lipid profile. Therefore, further study of PP-mi is not warranted at this time, and no clinical trial is on file with the FDA.

Unverified Answer

Is pp-mi intervention safe for people?

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The risk of developing dementia is substantial after cardiovascular mortality and can be significantly lowered following a single 2-hit genotype change at -636 promoter polymorphism of the SIRT1 gene. Further studies are needed to determine whether prevention of silent cardiovascular disease in older persons with this risk factor genotype would lead to reduction in cognitive decline. Clinically silent myocardial infarction and silent sudden arrhythmic death as well as other cardiovascular events, deaths, and strokes are also important triggers for cognitive decline.

Unverified Answer

What is pp-mi intervention?

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The study was not designed to show that participation in a p-mi program is efficacious in improving heart failure outcomes for the participants. There were no changes in the outcomes assessed in the participants and controls when they were enrolled or exited the study (12 months). Future, randomized clinical trials on longer length of follow up can provide the information needed to determine the true effects and benefits of the intervention.

Unverified Answer
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