A Positive Psychology Intervention to Promote Health Behaviors in Heart Failure: a Randomized, Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Feasibility of the PP-based Health Behavior Intervention
研究概览
简要总结
The focus of this study is to examine the feasibility, acceptability, and preliminary impact of a 12-week, telephone-delivered, positive psychology (PP)-based health behavior intervention in a group of patients with mild to moderate heart failure (HF), compared to a motivational interviewing- (MI-) based education condition and treatment as usual (TAU).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with NYHA class I, II, or III HF admitted to an MGH inpatient unit or outpatients at the MGH Heart Center or MGH-affiliated primary care clinic. Patients with NYHA class IV HF have ongoing HF symptoms at rest, making it difficult for them to increase physical activity and other health behaviors; therefore, they will not be included. HF diagnosis will be confirmed via chart review and with the patient's treatment team as needed.
- •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. The MOS has been used in multiple prior studies assessing adherence in cardiac patients, including our own studies in this population. This threshold score on the MOS will ensure that all participants will have the potential to improve their health behaviors.
排除标准
- •Cognitive deficits impeding a participant's ability to provide informed consent or participate, assessed via a 6-item cognitive test that is sensitive and specific for screening for cognitive impairment in research participants.
- •Medical conditions precluding interviews or likely to lead to death within 6 months.
- •Inability to speak English, inability to read or write, inability to walk, or lack of a telephone.
结局指标
主要结局
Feasibility of the PP-based Health Behavior Intervention
时间窗: Change between baseline and 12 weeks
Feasibility will be measured by examining the number of completed exercises for individuals randomized to the Positive Psychology (PP)-based intervention.
次要结局
- Acceptability of the Exercises(12 weeks)
- Change in PANAS Scores (Primary Psychological Outcome)(Baseline, 12 weeks, and 24 weeks)
- Changes in MOS SAS Scores(Baseline, 12 weeks, and 24 weeks)
- Changes in HADS-Anxiety Subscale Scores(Baseline, 12 weeks, and 24 weeks)
- Immediate Impact of the Exercises(Weekly, up to 12 weeks)
- Changes in LOT-R Scores(Baseline, 12 weeks, and 24 weeks)
- Change in HADS-Depression Subscale Scores(Baseline, 12 weeks, and 24 weeks)
- Changes in Self-Reported Medication Adherence (SRMA)(Baseline, 12 weeks and 24 weeks)
- Changes in SOM Scores(Baseline, 12 weeks, and 24 weeks)
- Changes in Sodium Intake (as Measured With the SSQ)(Baseline, 12 weeks, and 24 weeks)
- Changes in KCCQ Scores (Primary Functional Outcome)(Baseline, 12 weeks, and 24 weeks)
- Changes in SF-12 Scores(Baseline, 12 weeks, and 24 weeks)
- Feasibility of Actigraph(Baseline, 12 weeks and 24 weeks)
- Change in Moderate to Vigorous Physical Activity(Baseline, 12 weeks, and 24 weeks)
- Change in Physical Activity(Baseline, 12 weeks, and 24 weeks)
研究者
Christopher Celano
Assistant Psychiatrist
Massachusetts General Hospital