Effectiveness of the Aktivplan Digital Intervention for Supporting Regular Heart-healthy Levels of Physical Activity Following Completion of a Phase II Rehabilitation Programme: a Clinical Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 4
- 主要终点
- Recruitment rate
研究概览
简要总结
The goal of this clinical pilot / feasibility study is to determine the feasibility of conducting a large-scale clinical effectiveness trial of the aktivplan digital intervention in cardiac rehabilitation patients.
The main questions this study aims to answer are:
- Is it feasible to conduct a large-scale (fully powered) effectiveness trial of the aktivplan digital intervention?
- What is the usability, user experience and user acceptance of the aktivplan digital intervention?
Patients enrolled in a phase II cardiac rehabilitation programme will be randomly allocated to either the intervention group (aktivplan digital intervention) ot the usual care control group and followed-up for 10 weeks after discharge from cardiac rehabilitation.
Patients in the intervention group will be given the aktivplan application (app) on their smartphone. A rehabilitation professional will plan a personalised heart-healthy physical activity plan together with the patient and enter it to the aktivplan app. The patient will be asked to follow their personal physical activity plan for 10 weeks, using the aktivplan app to document completed physical activity sessions.
Patients in the control group will receive the usual standard of care without the aktivplan digital intervention.
Researchers will analyse information such as the rate of recruitment, participant attrition, data completeness and technical stability of the app to determine the feasibility of conducting a large-scale clinical effectiveness trial.
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
- 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
- •Enrollment to a cardiac rehabilitation programme phase II, or a rehabilitation programme phase II due to non-cardiac indication but displaying cardiovascular risk factors
- •Ownership and use of a smartphone compatible with the aktivplan digital intervention and with internet connection
- •Agreement to attend the study follow-up visit
- •Written informed consent to take part in the study
排除标准
- •Existing use of a digital intervention for regular heart-healthy physical activity
- •Medical contraindications for incremental cycle ergometry test
- •Medical contraindications for regular heart-healthy physical activity and sports
- •Medical contraindications for use of a smartphone
- •Inability to carry out cardiovascular training (e.g., due to significant musculoskeletal restrictions)
- •Participation in another clinical study within the past 6 months
- •Addiction or other medical conditions causing reduced decisional capacity
- •Pregnant women in the third trimester
- •Pregnant women in the first and second trimester with medical contraindication for physical activity and sports
- •Breastfeeding women with medical contraindication for physical activity and sports
- •Indication that patient is unlikely to follow study procedures (limited cooperation)
结局指标
主要结局
Recruitment rate
时间窗: 10 weeks
Number of recruits per week
Usability of the aktivplan digital intervention
时间窗: 10 weeks
mHealth App Usability Questionnaire (MAUQ)
Technical stability of the aktivplan digital intervention
时间窗: 10 weeks
Number and types of technical problems (qualitative data)
Use of alternative and additional strategies for supporting physical activity
时间窗: 10 weeks
Number and types of additional strategies (qualitative data)
Experiences and perspectives of rehabilitation professionals regarding the intervention and study procedures
时间窗: 10 weeks
Qualitative data from focus groups
Drop-out rate
时间窗: 10 weeks
Number of drop-outs in at the 10-week follow-up visit
Adherence to the aktivplan digital intervention
时间窗: 10 weeks
Automated usage logging of the aktivplan mobile application (Matomo platform)
Data completeness
时间窗: 10 weeks
Percentage of missing data fields in the study database
User experience of the aktivplan digital intervention
时间窗: 10 weeks
AttrakDiff Short Questionnaire
User acceptance of the aktivplan digital intervention
时间窗: 10 weeks
Mobile Application Rating Scale (MARS)
Experiences and perspectives of patients regarding their study participation
时间窗: 10 weeks
Qualitative data from semi-structured interviews
次要结局
- Physical activity behaviour(10 weeks)
- Weight(10 weeks)
- Blood pressure(10 weeks)
- Exercise capacity(10 weeks)
- Health-related quality of life(10 weeks)
- Exercise self-efficacy(10 weeks)
- HbA1c(10 weeks)
- Blood cholesterol(10 weeks)
- Smoking(10 weeks)
- Patient safety(10 weeks)