Increasing Risk Perception of Physical Activity Using Patient-targeted Feedback: Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Risk perception of physical activity level
研究概览
简要总结
The aim of this study is to evaluate the efficiency of a minimal intervention on risk perception of physical inactivity in patients with known coronary heart disease (CHD) and patients at risk for CHD. Therefore half of the patients (intervention group) get a personal feedback on their individual level of physical activity measured by pedometers and self-report questionnaires plus information about the risk factor 'physical inactivity' for heart diseases. Following the hypotheses the feedback should increase the patients risk perception of physical inactivity and furthermore increase physical activity.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known coronary heart disease or at least 2 risk factors for coronary heart disease
- •Age: 18 years up to 75 years
- •Sufficient language skills
- •Access to a telephone
- •Willingness to participate in telephone interviews
- •"Informed consent"
排除标准
- •Life threatening health status
- •Severe somatic or/and psychological disorder that needs urgent treatment
- •Hospital stay within the last 7 days
- •Surgical intervention plus hospital stay for at least 3 days within the last 2 months
- •Myocardial infarction within the last 3 month
- •Musculoskeletal diseases, which have a strong influence on physical activity
- •Severe cognitive or/and visual difficulties
研究组 & 干预措施
Pedometer+physical-activity-feedback
At cardiac consultation patients receive a patient-targeted individual physical-activity-feedback.
干预措施: Patient-targeted individual physical-activity-feedback (Behavioral)
Pedometer+physical-activity-feedback
At cardiac consultation patients receive a patient-targeted individual physical-activity-feedback.
干预措施: Pedometer (Device)
Pedometer-only
Patients use a Pedometer in order to measure their daily step number
干预措施: Pedometer (Device)
结局指标
主要结局
Risk perception of physical activity level
时间窗: Outcome measure is assessed at one month follow-up
time of measurement: one month after cardiac consultation
次要结局
- Physical activity Level (Pedometer, time spent sitting, IPAQ)(Outcome measure is assessed at one month follow-up and three months follow-up)
- Somatic symptom severity (PHQ-15)(Outcome measure is assessed at one month follow-up and three months follow-up)
- Quality of life (EQ-5D)(Outcome measure is assessed at one month follow-up and three months follow-up)
- New York Heart Association Class(Outcome measure is assessed at one month follow-up and three months follow-up)
- Risk perception of physical activity level(Outcome measure is assessed at three months follow-up)
- Adherence to the pedometer(Outcome measure is assessed at one month follow-up and three months follow-up)
- Satisfaction and acceptance of the feedback(Outcome measure is assessed at one month follow-up and three months follow-up)
- Depression severity (PHQ-9)(Outcome measure is assessed at one month follow-up and three months follow-up)
- Anxiety severity (GAD-7)(Outcome measure is assessed at one month follow-up and three months follow-up)
- Canadian Cardiology Society Class(Outcome measure is assessed at one month follow-up and three months follow-up)
研究者
Dr. Sebastian Kohlmann
Dr. rer. nat. Dipl. Psych.
Universitätsklinikum Hamburg-Eppendorf