Exercise is Medicine (EIM): A Quality Improvement and Pragmatic Trial at Emory Seavey Internal Medicine Clinic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Change in Physical Activity
研究概览
简要总结
Implementation of physical activity promotion in routine health care delivery is low because of multiple barriers including insufficient health system support, care team coordination, and scarcity of community resources for referring patients and technology tools for sustaining lifestyle changes. This study is a pilot project to test the feasibility of implementing a physical activity promotion protocol, including routine evaluation of patient's physical activity levels and provision of educational material in the clinical workflow. Physically inactive adult patients with at least one documented cardiovascular disease risk factor will be invited to participate in physical activity intervention. Patients will be randomized to receive a wearable device or a smartphone app to objectively monitor their physical activity. Participants will be further randomized to receive automated motivational text messages, or a personalized motivational message, or no messages. Participants will be followed through the 12 week intervention period and an additional 12 weeks with no intervention.
详细描述
Improving and maintaining health-enhancing levels of physical activity (PA) leads to reductions in the metabolic, hemodynamic, body composition, epi-genetic and functional status risk factors that heavily contribute to the development of many non-communicable chronic diseases. As such, PA has a significant role, in many cases comparable or superior to drug interventions, in the prevention and treatment of more than 40 diseases such as obesity, heart disease, diabetes, hypertension, cancer, depression, anxiety, arthritis, and osteoporosis.
While conceptually simple, implementing clinical-community linkages for PA promotion is hindered by barriers at multiple levels such as inadequate training and self-efficacy among health care providers (HCPs), insufficient health system support and care team coordination, and scarcity of certified community resources for referring patients. The challenge for HCPs and health systems is how to operationalize, standardize, and implement PA promotion in a cost-effective and innovative fashion.
This study is a pilot project to test the feasibility of implementing a physical activity promotion protocol including routine evaluation of patient's physical activity levels and provision of educational material in the clinical workflow of the Seavey Internal Medicine Clinic at Emory University. Physically inactive adult patients with at least one documented cardiovascular disease risk factor (overweight/obesity, dyslipidemia, hypertension, diabetes) but cleared for self-directed exercise by their treating clinician will be invited to participate in physical activity intervention. Patients will be randomized to receive a wearable device (Garmin vivofit 3) or a smartphone app (Microsoft Band) to objectively monitor their physical activity. Participants will be further randomized to receive automated motivational text messages, or a personalized motivational message, or no messages. Participants will be followed through the 12 week intervention period and an additional 12 weeks with no intervention. The researchers will assess changes in objectively-measured physical activity (primary outcome) and explore impact on secondary outcomes including cardiovascular disease (CVD) risk factors (assessed routinely as part of clinical management), as well as self-reported mental health, quality of life and exercise self-efficacy using validated questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least one documented cardiovascular disease risk factor
- •Not meeting physical activity (PA) guidelines (aerobic and/or muscle-strengthening standards)
- •contemplating PA engagement
- •Non-wheelchair bound (other assist devices will be acceptable) or major physical limitations for PA
- •Cleared for independent PA by their health care provider
- •Willingness to participate and provide written informed consent
- •Report access to a mobile phone with data plan and/or computer with internet access
- •Agrees to not own/use a different PA wearable device during the study period.
排除标准
- •Documented unstable angina or myocardial infarction in the past 3 months without having finalized an initial cardiac rehabilitation program;
- •Documented end-stage renal disease or life-threatening disease;
- •Diagnosed major mental health disorder;
- •Alcohol or drug abuse.
结局指标
主要结局
Change in Physical Activity
时间窗: Baseline through Week 24
Physical activity will be measured through the Microsoft Band app or with the Garmin vivofit 3. The physical activity of the participants will be monitored during the 12 week intervention period (when some study arms will receive motivational messages) and through 12 additional weeks of follow up.
次要结局
- Change in weight(Baseline through Week 24)
- Change in Center for Epidemiologic Studies Depression Scale (CES-D) Score(Baseline, Week 12, Week 24)
- Change in blood glucose(Baseline through Week 24)
- Change in triglycerides(Baseline through Week 24)
- Change in total cholesterol(Baseline through Week 24)
- Change in hypertension status(Baseline through Week 24)
- Change in Social Support and Exercise Survey Score(Baseline, Week 12, Week 24)
- Change in hemoglobin A1c (HbA1c)(Baseline through Week 24)
- Change in Short-Form Patient Satisfaction Questionnaire (PSQ-18) Score(Baseline, Week 12, Week 24)
- Change in 12-Item Short-Form Health Survey (SF-12) Score(Baseline, Week 12, Week 24)
- Change in Eating Habits Confidence Survey Score(Baseline, Week 12, Week 24)
- Change in Exercise Confidence Survey Score(Baseline, Week 12, Week 24)
- Change in 36-Item Short-Form Health Survey (SF-36) Score(Baseline, Week 12, Week 24)
研究者
Sharon Horesh Bergquist
Assistant Professor
Emory University