Clinical trial NCT04829617: Promoting Well-being and Health in Heart Failure
Official title: A Novel Behavioral Intervention to Promote Adherence in Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Heart Failure NYHA Class I
Heart Failure NYHA Class II
Heart Failure NYHA Class III
Keywords: Positive Psychology
Physical Activity
Low-Sodium Diet
Medication Adherence
Motivational Interviewing
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, single-blinded, controlled trial
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Health behavior adherence
timeFrame: Baseline, 12 Weeks, 24 Weeks, 48 Weeks
Secondary outcomes:
measure: Physical activity (in steps/day)
timeFrame: Measured for 7 days at baseline, 12 weeks, 24 weeks, and 48 weeks
measure: Objective medication adherence (Medication Event Monitoring System [MEMS] pill bottles)
timeFrame: Measured for 14 days at baseline, 12 weeks, 24 weeks, and 48 weeks
measure: Sodium Excretion (mEq/day)
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Positive Affect (Positive and Negative Affect Schedule [PANAS] positive affect items)
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Physical Function (PROMIS 20-item Physical Function Short Form [PF-20])
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
Other outcomes:
measure: Moderate to Vigorous Physical Activity (MVPA)
timeFrame: Measured for 7 days at baseline, 12 weeks, 24 weeks, and 48 weeks
measure: Sedentary Time (mean minutes/day)
timeFrame: Measured for 7 days at baseline, 12 weeks, 24 weeks, and 48 weeks
measure: Self-reported sodium intake (Scored Sodium Questionnaire [SSQ])
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Self-report medication adherence (tool from the NHLBI Heart and Soul Study)
timeFrame: Measured for 14 days at baseline, 12 weeks, 24 weeks, and 48 weeks
measure: Optimism (Life Orientation Test - Revised [LOT-R])
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Self-efficacy (General Self-Efficacy Scale [GSE])
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Depressive symptoms (Hospital Anxiety and Depression Scale - depression subscale [HADS-D])
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Anxiety (Hospital Anxiety and Depression Scale - anxiety subscale [HADS-A])
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Locus of control (Form C of the Multidimensional Health Locus of Control scale [MHLC Form C])
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Health-related quality of life (Medical Outcomes Study Short Form-12 [SF-12])
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: HF-related quality of life (Kansas City Cardiomyopathy Questionnaire [KCCQ] quality of life score)
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: HF symptoms (Kansas City Cardiomyopathy Questionnaire [KCCQ] total symptom score)
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Systolic and diastolic blood pressure
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Body mass index
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Waist circumference
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: LDL and HDL cholesterol
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Triglycerides
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Fasting blood glucose
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: 6-minute walk test (in meters traveled)
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Major Adverse Cardiac Events (MACE)
timeFrame: Throughout study period (estimated mean duration 28 months)
measure: All-cause Hospitalizations
timeFrame: Throughout study period (estimated mean duration 28 months)
measure: Heart Failure Hospitalizations
timeFrame: Throughout study period (estimated mean duration 28 months)
measure: Mortality
timeFrame: Throughout study period (estimated mean duration 28 months)
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Christopher M Celano, MD
role: PRINCIPAL_INVESTIGATOR
References: