Heart Failure Clinical Trial
Official title:
A Novel Behavioral Intervention to Promote Adherence in Heart Failure
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).
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. |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
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 |
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