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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout study period (estimated mean duration 28 months)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have heart failure but can still perform daily activities with little to moderate difficulty.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Health behavior adherence
Secondary outcome measures
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 moreOther outcome measures
6-minute walk test (in meters traveled)
All-cause Hospitalizations
Anxiety (Hospital Anxiety and Depression Scale - anxiety subscale [HADS-A])
+20 moreTrial 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).
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,201 Total Patients Enrolled
48 Trials studying Heart Failure
209,345 Patients Enrolled for Heart Failure
Christopher M Celano, MDPrincipal InvestigatorMassachusetts General Hospital
3 Previous Clinical Trials
70 Total Patients Enrolled
2 Trials studying Heart Failure
40 Patients Enrolled for Heart Failure
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Eligibility Criteria:
This trial includes the following eligibility 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.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.I cannot be physically active due to a condition like arthritis.You are already involved in another program that aims to improve health or behavior.
Research Study Groups:
This trial has the following groups:- Group 1: MI-alone Intervention
- Group 2: PP-MI Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are actively engaging in the experiment?
"Affirmative. According to clinicaltrials.gov, this research initiative is actively recruiting members; the trial was first posted on November 29th 2021 and last edited on December 21st 2021. The study requires 280 participants from 1 site for enrollment."
Answered by AI
Does this research endeavor still have spots available for participants?
"The details presented on clinicaltrials.gov show that this research is open to patient enrollment. The trial was first posted in November 2021 and the latest update took place in December of the same year."
Answered by AI
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