Promoting Well-being and Health in Heart Failure

Heart Failure Clinical Trial

Official title:

A Novel Behavioral Intervention to Promote Adherence in Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04829617
• Other study ID #: 2021P000882
• Status: Recruiting
• Phase: N/A
• Start date: November 29, 2021
• Est. completion date: June 30, 2026

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: Christohper M Celano, MD
• Phone: 617-726-6485
• Email: ccelano[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The focus of this study is to test the efficacy of a 12-week, phone-delivered Positive Psychology-Motivational Interviewing (PP-MI) intervention, with additional twice weekly PP and health behavior text messages for a total of 24 weeks (with interactive, algorithm-driven, goal-focused text messages in the final 12 weeks), compared to an attention-matched MI-based educational condition, in a randomized trial (NIH Stage II) of 280 patients with New York Heart Association class I-III Heart Failure (HF).

Description:

The investigators are proposing a study that will focus on testing the efficacy of a Positive Psychology-Motivational Interviewing (PP-MI) intervention, with additional twice weekly PP and health behavior text messages for a total of 24 weeks (with interactive, algorithm-driven, goal-focused text messages in the final 12 weeks) in patients with New York Heart Association class I-III HF. The investigators will enroll 280 HF patients, who will take part in a 12-week (with 24 weeks of supplemental text messages) health behavior intervention.

In this project, the investigators hope to do the following:

1. Examine the efficacy of a 12-week, phone-delivered PP-MI intervention for individuals with heart failure (HF) on health behavior adherence at 12 weeks (primary time point), 24 weeks, and 48 weeks.

2. Assess the intervention's impact on psychological outcomes, health-related quality of life (HRQoL), HF-specific quality of life, HF symptoms, and function.

3. Explore the intervention's impact on markers of cardiovascular health (e.g., blood pressure), as well as major adverse cardiac events, HF hospitalizations, and mortality.

Participants will undergo two visits (in-person or virtual) during which they will meet with study staff. During the first visit, participants will provide informed consent, answer questionnaires related to psychological and physical health and functioning, have their blood pressure and weight measured, and be asked to monitor their physical activity (using an accelerometer) for one week and medication adherence (using an electronic pill bottle) for two weeks. Participants will be given a urine collection container and asked to provide a urine sample within 4 hours of their first void and before eating breakfast on the day of Visit 2. At the second visit, the urine sample will be collected, and upon confirmation of adequate physical activity and medication adherence data, participants will be randomized to receive the PP-MI intervention or the MI-alone intervention.

Following randomization, all participants will be provided a treatment manual corresponding with their treatment condition, a Fitbit activity tracker, and other treatment materials. The appropriate intervention will be introduced, and the first exercise will be assigned.

Following the second visit, participants in both treatment conditions will complete twelve weekly phone sessions with a study trainer. The phone sessions primarily will include a review of the prior week's session content and a discussion of the rationale and assignment of the next week's exercise/assignment.

Participants in both treatment conditions will receive twice weekly text messages throughout the intervention (Weeks 1-12) and initial follow-up period (Weeks 13-24). During the intervention, these messages will provide information about the PP activity (PP-MI group) and health behavior goal (both groups) discussed that week. During Weeks 13-24, participants in the PP-MI condition will engage with twice weekly, automated, interactive text messages related to PP and health behavior goals. Individuals in the MI-alone group will receive identical messages related to setting health behavior goals as the PP-MI participants and will additionally receive a fixed test message providing education about health behavior adherence.

At Weeks 12, 24, and 48, participants will complete follow-up visits. One week prior to these visits, participants will be mailed an accelerometer and will wear it until their study visit. They will also be sent a container for urine collection, which they will bring to their follow-up visit. During these study visits, participants will be asked to answer questionnaires related to psychological and physical health and functioning, have their blood pressure, weight, and waist circumference measured, will perform a 6 minute walk test, and be asked about cardiovascular outcomes, including hospitalizations, cardiovascular procedures, and cardiac-specific hospitalizations.

Finally, participants will complete phone sessions every 6 months until study end to inquire about hospitalizations and adverse cardiac events.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

• 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.

Exclusion Criteria:

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

• Medical conditions likely to lead to death within 6 months.

• Inability to participate in physical activity due to another medical condition (e.g., arthritis).

• Inability to read, write, or speak in English.

• Current participation in another intervention or program that has been designed to promote well-being or health behavior adherence.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure NYHA Class I
• Heart Failure NYHA Class II
• Heart Failure NYHA Class III

Intervention

Behavioral:
• PP-MI Intervention
The 12-week PP-MI intervention focuses on enhancing well-being (through PP) and promoting adherence to physical activity, diet, and medications (through MI). 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. The PP portion of the program will focus on the cultivation of well-being through the performance of easy-to complete activities (e.g., using a strength in a new way) and review of the positive feelings they generate. The MI portion of the program will focus on assisting participants to monitor health behavior adherence, resolve ambivalence to behavior change, set realistic health behavior goals, problem-solve barriers, and identify resources to complete behavior change. Finally, participants will receive twice weekly text messages (for 24 weeks) to encourage completion of PP activities and engagement in health behaviors.
• MI-alone Intervention
The time- and attention-matched MI-alone intervention focuses on providing education about heart failure (HF) and promoting adherence to physical activity, diet, and medications. Each week, participants will independently complete an activity related to HF education or adherence to a health behavior, then complete a phone session with a study trainer. HF educational topics will include the causes and types of HF, risk factors for cardiovascular disease, methods for monitoring risk factors and symptoms, and the importance of adherence to physical activity, diet, and medications. For each health behavior, study trainers will assist participants to monitor adherence, identify realistic behavior goals, problem-solve barriers, and identify resources to complete behavior change. Finally, participants will receive twice weekly text messages (for 24 weeks) that provide education and encourage engagement in health behaviors.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Moderate to Vigorous Physical Activity (MVPA)	MVPA (reported in mean minutes of MVPA/day) will be measured via an accelerometer and recorded in mean minutes/day.	Measured for 7 days at baseline, 12 weeks, 24 weeks, and 48 weeks
Other	Sedentary Time (mean minutes/day)	Sedentary time (mean minutes/day) will be measured via Actigraph accelerometer.	Measured for 7 days at baseline, 12 weeks, 24 weeks, and 48 weeks
Other	Self-reported sodium intake (Scored Sodium Questionnaire [SSQ])	The Scored Sodium Questionnaire (SSQ) measures the frequency with which individuals have consumed sodium-containing foods in the past month.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	Self-report medication adherence (tool from the NHLBI Heart and Soul Study)	Medication adherence will be measured with the self-report medication adherence tool from the NHLBI Heart and Soul Study.	Measured for 14 days at baseline, 12 weeks, 24 weeks, and 48 weeks
Other	Optimism (Life Orientation Test - Revised [LOT-R])	Optimism will be measured using the LOT-R, a frequently used 6-item instrument that assesses dispositional optimism.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	Self-efficacy (General Self-Efficacy Scale [GSE])	Self-efficacy will be measured using the General Self Efficacy scale (GSE), a validated measure of self-efficacy, given its links to improved adherence.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	Depressive symptoms (Hospital Anxiety and Depression Scale - depression subscale [HADS-D])	Depressive symptoms will be measured using the 7-item depression subscale of the HADS.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	Anxiety (Hospital Anxiety and Depression Scale - anxiety subscale [HADS-A])	Anxiety will be measured using the 7-item anxiety subscale of the HADS.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	Locus of control (Form C of the Multidimensional Health Locus of Control scale [MHLC Form C])	Locus of control will be measured using the 18-item MHLOC.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	Health-related quality of life (Medical Outcomes Study Short Form-12 [SF-12])	The SF-12 will be used to assess health-related quality of life. The SF-12 produces both mental and physical component scores, both of which will be assessed this trial.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	HF-related quality of life (Kansas City Cardiomyopathy Questionnaire [KCCQ] quality of life score)	HF-related quality of life will be assessed using the quality of life score from the KCCQ.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	HF symptoms (Kansas City Cardiomyopathy Questionnaire [KCCQ] total symptom score)	HF symptoms will be measured using the KCCQ total symptom score.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	Systolic and diastolic blood pressure	Blood pressure (diastolic and systolic) will be measured by trained nurses using a standardized protocol.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	Body mass index	Height and weight (for calculation of body mass index) will be measured by trained nurses.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	Waist circumference	Waist circumference will be measured by trained nurses and/or dieticians.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	LDL and HDL cholesterol	Fasting lipids (including LDL and HDL cholesterol) will be measured via blood samples.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	Triglycerides	Fasting lipids (including triglycerides) will be measured via blood samples.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	Fasting blood glucose	Fasting blood glucose levels will be measured via a blood sample.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	6-minute walk test (in meters traveled)	A 6-minute walk test will be measured and monitored by trained nurses and/or dieticians to measure functional capacity.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	Major Adverse Cardiac Events (MACE)	MACE will be defined as mortality or hospitalization for HF or an acute coronary event (percutaneous coronary intervention or acute coronary syndrome). Data regarding hospitalizations and mortality will be obtained using a three-pronged approach consisting of systematic queries of participants, electronic health record review, and review of records from the National Death Index.	Throughout study period (estimated mean duration 28 months)
Other	All-cause Hospitalizations	We will record all-cause hospitalizations for all participants from enrollment to the end of the study data collection period, using systematic queries of participants and review of electronic health records from all Mass General Brigham-affiliated hospitals.	Throughout study period (estimated mean duration 28 months)
Other	Heart Failure Hospitalizations	We will record HF hospitalizations for all participants from enrollment to the end of the study data collection period, using systematic queries of participants and review of electronic health records from all Mass General Brigham-affiliated hospitals.	Throughout study period (estimated mean duration 28 months)
Other	Mortality	We will record vital status for participants from enrollment to the end of study data collection. Data regarding mortality will be obtained using electronic health record review and review of records from the National Death Index.	Throughout study period (estimated mean duration 28 months)
Primary	Health behavior adherence	Composite score of overall activity (measured by accelerometer in steps/day), sodium excretion (urine sodium in mEq/day), and medication adherence (Medication Event Monitoring System [MEMS] electronic pill bottle). This composite score will be created by calculating z scores for each individual outcome measure and then averaging them for each participant at each time point.	Baseline, 12 Weeks, 24 Weeks, 48 Weeks
Secondary	Physical activity (in steps/day)	Physical activity (steps) will be measured via an accelerometer. We will use established accelerometer protocols to measure the mean number of steps taken per day at each time point.	Measured for 7 days at baseline, 12 weeks, 24 weeks, and 48 weeks
Secondary	Objective medication adherence (Medication Event Monitoring System [MEMS] pill bottles)	Medication adherence will be measured using MEMS electronic pill bottles. Participants will receive a MEMS pill bottle at the initial study visit and will be asked to put one cardiac medication (loop diuretic, ACE inhibitor, beta blocker, or aspirin, in that order) in the bottle and then use it throughout the study period (48 weeks). Adherence will be measured by the percentage of appropriate bottle openings over a 2-week period at baseline and the follow-up time points.	Measured for 14 days at baseline, 12 weeks, 24 weeks, and 48 weeks
Secondary	Sodium Excretion (mEq/day)	Objective sodium intake will be assessed through the measurement of urinary sodium excretion. Participants will provide a sample of their second voiding of the day, and from this sample, urine sodium and urine creatinine will be measured.	Baseline, 12 weeks, 24 weeks, 48 weeks
Secondary	Positive Affect (Positive and Negative Affect Schedule [PANAS] positive affect items)	Positive affect will be measured using the 10 positive affect items from the PANAS, a well-validated scale used in numerous other behavioral intervention trials.	Baseline, 12 weeks, 24 weeks, 48 weeks
Secondary	Physical Function (PROMIS 20-item Physical Function Short Form [PF-20])	The PROMIS 20-item short form (PF-20) will be used to assess physical function.	Baseline, 12 weeks, 24 weeks, 48 weeks