Developing a Positive Psychology Intervention to Promote Health Behaviors in Heart Failure: proof-of Concept Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 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 our customized positive psychology (PP)-based health behavior intervention in a group of patients with mild to moderate heart failure (HF).
详细描述
The investigators are proposing a study that will specifically and innovatively focus on the development of a novel positive psychology intervention that is adapted for patients with HF. The MGH inpatient units and MGH Heart Center outpatients will serve as the source of subjects for the study, with patients who have a diagnosis of HF serving as potential subjects. The investigators will enroll 10 HF patients, who will take part in an 10-week PP-based health behavior intervention.
In this project, the investigators hope to do the following:
- Test an 10-week, telephone-delivered health behavior intervention utilizing PP exercises and systematic goal-setting in a brief, non-randomized, proof-of-concept trial (N=10).
- Determine whether this initial intervention is feasible in a small cohort of HF patients.
- Explore potential benefits of the intervention on outcomes of interest (e.g., optimism, positive affect).
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 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 under go an initial visit during which they will meet with study staff in person (or if preferred over the phone).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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. 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 SAS) items regarding diet/exercise/medications. The MOS SAS 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 SAS 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: 10 weeks
Feasibility will be measured by examining the number of completed exercises.
次要结局
- Changes in HADS-Anxiety Subscale Scores(Change in score from Baseline to 10 weeks)
- Change in HADS-Depression Subscale Scores(Change in score from Baseline to 10 weeks)
- Changes in Daily Sodium Intake (as Measured With the SSQ)(Change in score from Baseline to 10 weeks)
- Change in Physical Activity(Baseline and 10 weeks)
- Changes in PANAS Scores(Change in score from Baseline to 10 weeks)
- Changes in LOT-R Scores(Change of score from Baseline to 10 weeks)
- Changes in KCCQ Scores(Change in score from Baseline to 10 weeks)
- Changes in SF-12 Scores(Change in score from Baseline to 10 weeks)
- Acceptability of the Exercises: Utility Score(Weeks 1-10)
- Changes in MOS SAS Scores(Change in score from Baseline to 10 weeks)
- Acceptability of the Exercises: Ease Score(Weeks 1-10)
- Immediate Impact of the Exercises: Optimism Rating(Weeks 1-10)
- Self-Reported Medication Adherence (SRMA)(Change in score from Baseline to 10 weeks)
- Change in Moderate to Vigorous Physical Activity (Actigraph)(Change in MVPA from Baseline to 10 weeks)
- Feasibility of Actigraph(Baseline and 10 weeks)
- Immediate Impact of the Exercises: Positive Affect Rating(Weeks 1-10)
研究者
Christopher Celano
Assistant in Psychiatry
Massachusetts General Hospital