Secondary Prevention and Application-based Lifestyle Support for Patients With Intermittent Claudication
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Pain free walking distance
研究概览
简要总结
A randomized controlled pilot trial will be used to test Lifepod®PAD as secondary prevention support system. Approximately 60 patients with intermittent claudication at the Department of vascular diseases at Skåne University hospital will be invited. The intervention group (n=30) will test Lifepod PAD for 3 months and the control group (n=30) will receive secondary prevention as usual. Primary outcome is pain free walking distance and secondary outcomes will be quality of life, illness perception, ankle brachial pressure, self-efficacy, adherence to medical treatment and blood pressure. Acceptability, delivery of the intervention, expected sample size and effect size, procedure of randomization and follow-ups will be evaluated. The outcome will be used to design a main randomized trial. Combinations of quantitative measures and qualitative interviews will be used to understand the process in detail.
详细描述
A randomized controlled pilot trial will be used to test the application-based support systems Lifepod®PAD that are developed in collaboration with Cross Technology Solutions based on results from our systematic review and previous research testing the Lifepod® system in patients with myocardial infarction.
Sample Approximately 60 patients with intermittent claudication diagnosed at the Department of vascular diseases at Skåne University hospital will be invited to participate. The participants should have access to a smartphone or tablet. For the randomization, envelopes will be prepared by a member of the research group and then mixed by another member of the group. After receiving informed consent, the participants are randomized by drawing one of the sealed envelopes with the information in which group they are included. The trial will have two arms; one group will test Lifepod®PAD (n=30) for three months and one control group (n=30) will receive secondary prevention as usual.
Data collection All participants will be invited to a separate appointment at the vascular open clinic at baseline and after three months and measured regarding weight, blood pressure, ABPI, six minutes walking test and pain. To calculate the estimate 10-year risk of manifesting clinical cardiovascular disease, the Framingham Risk Score will be used. Further, a questionnaire will be answered at baseline and after three months containing the instruments, VascuQoL-6, Health Education Impact Questionnaire (hei-Q) and Medication Adherence Report Scale-5.
Patients randomized to Lifepod®PAD will get access and be introduced to the Lifepod®PAD support system software. Patients in the control group will receive usual care meaning advice about lifestyle changes and medication from the physician at the visit in the vascular open clinic.
After completing the intervention, a random number of patients who have tested Lifepod®PAD will be invited to take part in focus group interviews to discuss their experiences of using the devices. The interviews will be analyzed by thematic content analysis.
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
- •Patients with intermittent claudication diagnosed at the Department of vascular diseases at Skåne University hospital.
- •The participants should have access to a smartphone or tablet and be able to speak and understand Swedish.
排除标准
- •Patients with intermittent claudication who are considered for revascularization.
结局指标
主要结局
Pain free walking distance
时间窗: Change from baseline in pain free walking distance baseline at three months
Pain free walking distance will be measured by 6 minutes walking test.
次要结局
- Ankle brachial pressure index(Change from baseline in ankle brachial pressure index at three months)
- Quality of life assessment(Change from baseline in Vascuqol 6 total score (min 6 max 24, higher total score means better quality of life) at three months)
- Self efficacy(Change from baseline in General Self- Efficacy Scale (min 10 max 40 in total score a higher total score indicates more self efficacy) at three months)
- Illness perception(Change from baseline in Illness Perception scale (Include three sections that each have a totalscore, a high totalscore means a personal understanding of illness) at three months)
- Medication adherence(Change from baseline in Medication Adherence Report Scale (min 5 max 25 in total score a higher total score indicates higher level of adherence) at three months)
研究者
Christine Kumlien
Professor
Malmö University