A Lifestyle-Based Mobile Health Strategy for Cardiovascular Disease Prevention in Graduates From Cardiac Rehabilitation: VIDA Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Change in fitness (peak VO2mL/kg/min) as measured by cardiopulmonary exercise test (CPET).
研究概览
简要总结
The purpose of this study is to understand the effects of a mobile health cardiovascular prevention program in patients who have recently graduated from cardiac rehabilitation. The mobile health program will focus on promoting healthy lifestyles through the use of a mobile application (app), mobile physical activity monitor and a system of remote health coaching.
By testing a novel mHealth intervention focused on lifestyle modification, this trial will address a critical evidence gap in the care of patients after they graduate from CR. Many patients who graduate from traditional CR struggle with unhealthy lifestyles, and these patients currently have no lifestyle-based care strategies to help them. The results of this study have the potential to lead to new sustainable and resource-efficient, lifestyle-based preventive care strategies for patients with stable CVD.
详细描述
This is a single-center, randomized trial designed to examine the hypothesis that a lifestyle-based mobile health cardiovascular disease (CVD) prevention program administered to graduates of a cardiac rehabilitation (CR) program will improve physical activity, body composition, fitness, and quality of life (QOL).
The investigators may enroll up to 52 men and women volunteers from a pool of graduates of the Duke Cardiac Rehabilitation Program who are initially eligible to participate in this study. Of the 52 men and women volunteers who may be initially consented, it is anticipated that a portion (potentially 30%) may drop out during the study timeline, and approximately 40 are expected to complete this study. Following informed consent and baseline testing, the participants will be randomized in a 3:1 fashion to receive VIDA's 12-week mHealth program focused on lifestyle modification through remote health coaching in order to improve physical activity, body composition, and fitness. The multi-domain mHealth intervention will mirror traditional CR programs by focusing primarily on a structured physical activity intervention within the context of a comprehensive lifestyle program. Physical activity will be monitored by Fitbits and will be integrated into VIDA's mHealth platform which will also include modules on physical activity, weight management, heart healthy diet, medication adherence, coping with a chronic disease, psychosocial management, and stress management/sleep. Health coaches will be used to guide patients through the 12-week program. All participants will undergo measures of physical activity, body composition, fitness, and QOL at baseline and at 12-weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Graduates of CR, who were originally enrolled in CR following myocardial infarction (MI), percutaneous coronary intervention (PCI), or coronary artery bypass graft (CABG) or with stable angina
- •Adequate clinical stability has been achieved in the judgment of the investigator to allow participation in study assessments and the intervention
- •Ability to participate in a mobile health program with access to smartphones utilizing Apple and Android platforms
- •Signed informed consent document indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the study
排除标准
- •Acute symptoms of coronary artery disease
- •Decompensated heart failure
- •Severe valvular heart disease
- •Severe pulmonary hypertension
- •End stage renal disease
- •Heart failure, New York Heart Association (NYHA) class IV
- •Cardiac transplantation
- •Terminal illness with life expectancy < 1 year
- •Impairment from stroke, injury or other medical disorder that precludes participation in the intervention
- •Dementia that precludes ability to participate in and follow study protocols
- •Enrollment in a clinical trial not approved for co-enrollment
- •Inability or unwillingness to comply with the study requirements
研究组 & 干预措施
Mobile Health Application Group
VIDA is a mobile technology that is well positioned to provide healthcare coaching. After completing the CR program, each participant will have access to the VIDA mobile phone platform for the 12-week intervention, and be instructed to download the app on his/her smart phone. VIDA will assign an individual professional health coach selected from a pool of well-trained and experienced health professionals-nutritionists, fitness trainers, nurses and health educators. Each coach will engage their patient in a productive and meaningful health mentorship on a daily basis. The coach and patient work as a team to successfully set goals and make small changes that add up to significant improvements in the patients' dietary choices, physical activity, medication management, as well as understanding of their health status.
Physical Activity: A goal of "total number of steps" to attain daily will be provided by the Duke study team to the patient and monitored using a Fitbit activity tracker.
干预措施: Mobile Health Application (Behavioral)
Usual Care Group
Participants randomized to the usual care control arm will follow standard care as ordered by their individual, treating physician. Participants in the UC control arm will not receive any specific lifestyle recommendations from study personnel. They may, however, receive any lifestyle recommendations deemed appropriate by their usual clinical care providers. All participants will be contacted by study personnel in order to schedule visits at baseline and 12-weeks for the outcome assessments.
结局指标
主要结局
Change in fitness (peak VO2mL/kg/min) as measured by cardiopulmonary exercise test (CPET).
时间窗: Baseline and 14-weeks
peak VO2mL/kg/min
次要结局
- Understand the feasibility and implementation of this novel mhealth treatment strategy.(14-weeks)
- Change in Physical Activity as measured using a Fitbit(Baseline and 14-weeks)
- Change in Quality of Life (QOL) as measured by Seattle Angina Questionnaire (SAQ).(Baseline and 14-weeks)
- Change in Medication Adherence as measured by Morisky Medication Adherence Scale (MMAS-8).(Baseline and 14-weeks)
- Change in Body Mass(Baseline and 14-weeks)
- Change in Body Mass Index(Baseline and 14-weeks)
- Change in waist circumference(Baseline and 14-weeks)