A Pilot Feasibility Study to Promote Physical Activity Motivation in Cardiovascular Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Percentage of approached patients included
研究概览
简要总结
This study investigates the feasibility of an app based intervention, which uses questionnaires and personalized motivational messages to achieve change in physical activity and sedentary behaviour of cardiovascular patients. The questionnaires and messages are based on behaviour change theories, such as the transtheoretical model. The intervention will take place over eight weeks. One week before and during the last week, physical activity will be measured via accelerometers. A comprehensive questionnaire will be given before and at the end of the intervention and Feasibility measures will be evaluated at the end as well, including an optional qualitative interview with the participants.
详细描述
Cardiovascular diseases are the leading cause of death and disability worldwide. They are mainly caused by lifestyle risk factors, such as physical inactivity, which is also the fourth leading risk factor for mortality. Regular physical activity is crucial for the prevention and treatment of cardiovascular diseases. Nevertheless, success in achieving long-term adherence to physical activity recommendations after an acute cardiac event or even after exercise-based cardiac rehabilitation is rather low. Furthermore, even though most research has focused on physical activity, engaging in reduced amounts of sedentary behavior is also crucial, as it represents an important cardiovascular risk even after adjusting for physical activity. Health behavior change theories, such as the transtheoretical model, and empirical evidence highlight the importance of motivation and motivational factors in the behavior maintenance or change process. Thus, the main goal of the present study is to assess preliminary effectiveness of an intervention mostly based on the transtheoretical model to promote cardiovascular patients' motivation to be physically active and to engage in reduced amounts of sedentary behavior. Most intervention components will be delivered digitally to the participants' smartphones via a study specific app. Furthermore, weekly questionnaires allow the investigators' to individualize the intervention components and investigate associations not only between-subjects, but also within-subjects over time, which is essential and has been neglected in the literature. The primary objective is to assess study feasibility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Cardiovascular disease patients
- •Participating in cardiovascular rehabilitation OR having received the recommendation from a cardiologist to participate in cardiovascular rehabilitation and having refused
- •Signing the informed consent form
- •Owning a smartphone with internet access
排除标准
- •Age under 18 years
- •Having a contraindication for physical activity
- •Existing or suspected non-fulfilment of the participation requirements
- •Inability to follow the procedures of the study (e.g., by not speaking German, being unable to read or write, or severe cognitive impairment)
- •Being in palliative care
- •Being pregnant
- •Having an assisted living situation
- •Stroke patients
研究组 & 干预措施
Intervention group
This Group will be using the iPAL App for 8 Weeks
干预措施: iPAL App (Behavioral)
结局指标
主要结局
Percentage of approached patients included
时间窗: Approx. 5 Months
The goal is to include at least 10% of approached patients.
Completion of study assessments
时间窗: Participants may fill out study questionnaires weekly during the 8-week intervention or not.
The goal is that, on average participants complete at least 4 out of 9 of the questionnaires of the study. Excluding dropouts.
Dropout rate
时间窗: Participants can dropout at any time during the study (during 9 weeks for each participant)
The goal is that the dropout rate is lower than 50%
次要结局
- Self-efficacy(Weekly right before, during and right after the 8-week intervention for each participant.)
- Overall satisfaction(Last questionnaire of the study for each participant (post questionnaire right after the 8 intervention weeks; 9 weeks after study start))
- Affect(Weekly right before, during and right after the 8-week intervention for each participant.)
- Usability(Last questionnaire of the study for each participant (post questionnaire right after the 8 intervention weeks; 9 weeks after study start))
- Needs assessment(Last questionnaire of the study for each participant (post questionnaire right after the 8 intervention weeks; 9 weeks after study start))
- Processes of change(Weekly right before, during and right after the 8-week intervention for each participant.)
- Temptation(Weekly right before, during and right after the 8-week intervention for each participant.)
- Motivation(Weekly right before, during and right after the 8-week intervention for each participant.)
- Stage of change(Weekly right before, during and right after the 8-week intervention for each participant.)
- Habit(Weekly right before, during and right after the 8-week intervention for each participant.)
- Physical activity(Self-report: Weekly right before, during and right after the 8-week intervention. Device-based: during the 8 days before and the last 7 days of the intervention.)
- Sedentary behaviour(Self-report: Weekly right before, during and right after the 8-week intervention. Device-based: during the 8 days before and the last 7 days of the intervention.)
- Engagement(Last questionnaire of the study for each participant (post questionnaire right after the 8 intervention weeks; 9 weeks after study start))
- Satisfaction with the specific intervention components(Last questionnaire of the study for each participant (post questionnaire right after the 8 intervention weeks; 9 weeks after study start))
- Decisional balance(Weekly right before, during and right after the 8-week intervention for each participant.)
- Social support(Weekly right before, during and right after the 8-week intervention for each participant.)
- Self reported health-related quality of life(Weekly right before, during and right after the 8-week intervention for each participant.)
研究者
Claudio Nigg
Prof. Dr. Claudio Nigg
University of Bern