Researching Emotions And Cardiac Health: Phase III (REACH III)
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|ClinicalTrials.gov Identifier: NCT03220204|
Recruitment Status : Recruiting
First Posted : July 18, 2017
Last Update Posted : March 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Congestive Heart Failure Emotions Patient Compliance||Behavioral: PP-based health behavior intervention Behavioral: MI-based educational control condition||Not Applicable|
The investigators are proposing a study that will focus on the implementation of a novel PP-based health behavior intervention that is adapted for patients with HF. The MGH inpatient units, MGH Heart Center, and MGH primary care clinic outpatients will serve as the source of participants for the study, with patients who have a diagnosis of HF serving as potential participants. The investigators will enroll 60 HF patients, who will take part in a 12-week PP-based health behavior intervention.
In this project, the investigators hope to do the following:
- Test a 12-week, telephone-delivered health behavior intervention utilizing PP exercises and systematic goal-setting in a three-arm, randomized, controlled pilot trial in patients with mild to moderate HF (N=60).
- Determine whether this optimized intervention is feasible in a small cohort of HF patients.
- Explore potential benefits of the intervention on outcomes of interest (e.g., psychological health, functioning, and health behavior adherence) compared to a motivational interviewing- (MI) based education condition and treatment as usual (TAU).
Baseline information about enrolled participants will be obtained from the patients, care providers, and the electronic medical record as required for characterization of our population. This information will include data regarding medical history (history of prior acute coronary syndrome, coronary artery disease, coronary artery bypass graft, congestive HF, hypertension, diabetes mellitus, hyperlipidemia, and current smoking), current medical variables (renal function, left ventricular ejection fraction, NYHA class), medications, and sociodemographic data (age, gender, race/ethnicity, living alone).
Participants will undergo two in person visits during which they will meet with study staff in person (or if preferred over the phone). In their first visit, they will answer questionnaires related to psychological and physical health and functioning and will be asked to wear an accelerometer for one week to measure their baseline physical activity. At their second in-person visit, they will be randomized to receive (1) the PP-based health behavior intervention, (2) the MI-based educational condition, or (3) TAU. Participants in the TAU group will not receive any additional intervention but will complete follow-up phone calls at 12 and 24 weeks.
Following randomization, participants in the two treatment groups will be provided a treatment manual corresponding with their treatment condition with weekly exercises, along with a copy of the Learning to Live with Heart Failure guide. The appropriate intervention will be introduced, and the first exercise will be assigned. Finally, participants in both treatment groups will receive a personal step counter to use over the course of the study.
Following the second in-person visit, participants in the PP-based intervention and MI-based control condition groups will complete twelve 30- to 45-minute 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.
At Weeks 12 and 24, a member of the study staff will call participants to repeat the self-report questionnaires that were administered at baseline. At these two time points, participants also will be asked to wear an accelerometer for an additional 7 days to measure physical activity.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, single-blinded, controlled trial|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Participants and treating study staff will be aware of the participant's treatment condition. However, follow-up assessments will be performed by a study staff member that is masked to the participant's treatment condition.|
|Official Title:||A Positive Psychology Intervention to Promote Health Behaviors in Heart Failure: a Randomized, Controlled Pilot Trial|
|Actual Study Start Date :||September 1, 2017|
|Estimated Primary Completion Date :||November 1, 2019|
|Estimated Study Completion Date :||November 1, 2019|
Experimental: PP-based health behavior intervention
Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (b) a discussion of the rationale of the next week's PP exercise through a guided review of the PP manual, and (c) assignment of the next week's PP exercise. Additionally for the goal-setting portion, participants will (a) review their goals and 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.
Behavioral: PP-based health behavior intervention
The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence.
Experimental: MI-based educational control condition
Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics.
Behavioral: MI-based educational control condition
The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.
No Intervention: Treatment as Usual (TAU)
Participants in the TAU group will not receive any interventions between the baseline visit and follow-up visits.
- Feasibility of the PP-based health behavior intervention [ Time Frame: Change between baseline and 12 weeks ]Feasibility will be measured by examining the number of completed exercises.
- Changes in PANAS Scores (primary psychological outcome) [ Time Frame: Baseline, 12 weeks, and 24 weeks ]
The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with HF, will be used to measure positive affect.
For all secondary outcome measures, 12 weeks will be considered our primary study outcome timepoint.
- Changes in LOT-R Scores [ Time Frame: Baseline, 12 weeks, and 24 weeks ]Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism.
- Changes in SOM Scores [ Time Frame: Baseline, 12 weeks, and 24 weeks ]The State Optimism Measure (SOM) will be used to measure state optimism.
- Changes in HADS Scores [ Time Frame: Baseline, 12 weeks, and 24 weeks ]The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients.
- Changes in KCCQ Scores (primary functional outcome) [ Time Frame: Baseline, 12 weeks, and 24 weeks ]The Kansas City Cardiomyopathy Questionnaire is a well-validated questionnaire of health status in HF. The full scale will be used to measure HF-specific health-related QoL (HRQoL), and an eight-question subset of the KCCQ will be used as a measure of HF symptoms.
- Changes in SF-12 Scores [ Time Frame: Baseline, 12 weeks, and 24 weeks ]The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life. This is an instrument which has been used in multiple cardiac studies in the past.
- Changes in MOS Scores [ Time Frame: Baseline, 12 weeks, and 24 weeks ]Three Medical Outcomes Study Specific Adherence Scale (MOS) items assessing medication, diet, and exercise, will be measured individually and as a composite score.
- Changes in sodium intake (as measured with the SSQ) [ Time Frame: Baseline, 12 weeks, and 24 weeks ]The Scored Sodium Questionnaire (SSQ) is a self-report scale that assesses the frequency with which participants consume a variety of sodium-containing foods, ranging from "Rarely or Never Eaten" to "At Least Once Daily."
- Physical Activity (Actigraph; primary health behavior outcome) [ Time Frame: Baseline, 12 weeks, and 24 weeks ]ActiGraph GT3X+ step counters are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. We will measure both number of steps per day (primary physical health outcome) and average daily minutes engaging in moderate to vigorous physical activity.
- Feasibility of Actigraph [ Time Frame: Baseline, 12 weeks and 24 weeks ]Feasibility will be measured by examining the rates of use of the Actigraph.
- SRMA [ Time Frame: Baseline, 12 weeks and 24 weeks ]The Self-Reported Medication Adherence (SRMA) asks what percent of the time (in 10% increments) participants took all of their medications as prescribed in the past week and in the past 2 weeks.
- Acceptability of the exercises [ Time Frame: Weekly, up to 12 weeks ]Participants will provide ratings of ease and utility after each exercise, measured on a 10-point Likert scale.
- Immediate impact of the exercises [ Time Frame: Weekly, up to 12 weeks ]Participants will provide ratings of optimism and positive affect, before and after each exercise, measured on a 10-point Likert scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03220204
|Contact: Christopher Celano, MD||(617) firstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Christopher Celano, MD 617-726-6485 email@example.com|
|Principal Investigator:||Christopher Celano, MD||Massachusetts General Hospital|