About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
PP-MI Intervention
BehavioralThe 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
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Other outcomes
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.
Sedentary Time (mean minutes/day)
Sedentary time (mean minutes/day) will be measured via Actigraph accelerometer.
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.
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.
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