A Text Message Intervention to Promote Health Behaviors in Cardiac Risk Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Proportion of messages correctly delivered
研究概览
简要总结
This is a randomized pilot trial to examine the feasibility, acceptability, and preliminary efficacy of an adaptive text message intervention (TMI) to promote well-being and health behavior adherence in 60 patients with two or more cardiac risk conditions (hypertension, type 2 diabetes, or hyperlipidemia).
详细描述
The investigators have developed an adaptive text message intervention (TMI) that uses participant feedback for individual messages and progress towards health goals to deliver increasingly personalized positive psychology (PP) and health behavior text messages over time. The investigators aim to examine its feasibility, acceptability, and preliminary efficacy in a randomized, controlled pilot trial in 60 adults with two or more cardiac risk conditions (hypertension, type 2 diabetes, or hyperlipidemia).
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)
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
- •Cardiac risk conditions. Participants will have two or more of hypertension, type-2 diabetes, and hyperlipidemia. Patients will have met 2+ of 2017 AHA-ACC criteria for hypertension (SBP ≥130, DBP ≥80), 2018 ADA criteria for type-2 diabetes (e.g., A1C ≥6.5%), and 2013 AHA-ACC criteria for hyperlipidemia (e.g., LDL cholesterol ≥190), via medical record review, with confirmation by healthcare providers as needed.
- •Low physical activity or elevated sedentary leisure time (SLT). Low activity will be defined as ≤150 minutes/week of moderate to vigorous activity (MVPA), which is an ADA-recommended level of MVPA; elevated SLT will be ≥120 min/day, which is linked to adverse medical health. As initial screens for both MVPA and SLT, we will use the International Physical Activity Questionnaire (IPAQ). Patients reporting ≤150 min/week of MVPA or ≥120 min/day of SLT will wear accelerometers for 10 days to confirm low MVPA/high SLT (patients will indicate their leisure time hours to allow assessment of SLT during those hours).
- •Suboptimal diet. Participants must also report either fewer than 5 daily servings of fruit/vegetables (measured by the Behavioral Risk Factor Surveillance System's [BRFSS] Fruit and Vegetable Consumption Module) or have a score of ≥70 on the MEDFICTS scale for fat/cholesterol intake, representing high risk. We will require diet and activity deficits to ensure that a broad range of messages will be relevant to every participant as we explore the utility of individual messages and patterns of message selection in this initial study.
- •Ability to receive text messages. Participants must have a cellular phone that receives texts and that they use at least daily. We will remunerate them the cost of receiving the messages as needed.
- •Ability to read in English or Spanish. Text messages will be available in English and Spanish.
排除标准
- •Existing coronary artery disease (CAD; diagnosed via cardiac catheterization using standard coronary artery stenosis definitions or prior ACS).
- •An unrelated condition limiting physical activity.
- •Participation in programs focused on cardiac prevention or well-being (e.g., cardiac rehabilitation).
- •A cognitive disturbance precluding participation or informed consent, assessed using a six-item screen designed to assess suitability for research participation.
结局指标
主要结局
Proportion of messages correctly delivered
时间窗: 12 weeks
Proportion of adaptive TMI messages correctly selected/sent will be included as a measure of feasibility.
Rates of feedback to individual text messages
时间窗: 12 weeks
Rates of feedback to individual text messages will be included as a measure of feasibility.
Participant's mean ratings of message utility to measure acceptability of the text-message intervention
时间窗: 12 weeks
0-10 Likert scale score regarding the utility of that day's text message
次要结局
- Change in Life Orientation Test-Revised Score(Baseline, 12 weeks and 24 weeks)
- Change in Positive and Negative Affect Schedule (PANAS) Score(Baseline, 12 weeks and 24 weeks)
- Change in General Self-Efficacy Scale score(Baseline, 12 weeks and 24 weeks)
- Change in HADS-D Score(Baseline, 12 weeks and 24 weeks)
- Change in Multidimensional Scale of Perceived Social Support Score(Baseline, 12 weeks and 24 weeks)
- Change in self-report physical activity time measured by International Physical Activity Questionnaire(Baseline, 12 weeks and 24 weeks)
- Change in Moderate to vigorous physical activity (minutes) measured via accelerometer(Baseline, 12 weeks and 24 weeks)
- Change in physical activity (steps) measured via accelerometer(Baseline, 12 weeks and 24 weeks)
- Change in physical function measured by 6-minute test(Baseline, 12 weeks and 24 weeks)
- Change in Multidimensional Health Locus of Control Score(Baseline, 12 weeks and 24 weeks)
- Change in Behavioral Risk Factor Surveillance System [BRFSS] Fruit and Vegetable Consumption Module(Baseline, 12 weeks and 24 weeks)
- Change in physical function measured by PROMIS 20-item(Baseline, 12 weeks and 24 weeks)
- Change in HADS-A Score(Baseline, 12 weeks and 24 weeks)
- Change in MEDFICTS score(Baseline, 12 weeks and 24 weeks)
- Change in sedentary time measured via accelerometer(Baseline, 12 weeks and 24 weeks)
研究者
Jeff C. Huffman, MD
Director of Cardiac Psychiatry Research Program
Massachusetts General Hospital