A Usability Study of a Tele-health Service for Patients With Peripheral Arterial Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Patient satisfaction with the telehealth service.
研究概览
简要总结
The aim of the study is to analyze the applicability (usability) of a tele-health service as part of a potential disease management program for patients with peripheral arterial disease.
The following investigations will be conducted as part of the usability study. In the context of a tele-health service, knowledge, physical condition (including walking distance) will be documented during face-to-face and televisits, dislocated supervised gait training and education will be provided, and satisfaction with the tele-health service will be evaluated.
详细描述
Disease management programs (DMPs) are one of the methods used to optimize the care of patients with chronic diseases. DMPs are coordinated health care measures for patient populations with diseases in which active patient participation in treatment can lead to substantial effects. Specific treatment regimens, based on evidence-based treatment guidelines and structured patient information, are predominantly aimed at preventing disease exacerbations and complications. The World Health Organization (WHO) also recommends, among other things, forcing patient adherence through structured information and patient empowerment strategies to establish participatory treatment.
Peripheral arterial disease (PAD) causes oxygen and nutrient deprivation of tissues through narrowing of arterial vessels in the extremities. The cause of PAD is arteriosclerosis. The course of the disease begins asymptomatically and manifests itself over time with pain and cramps predominantly in the muscles of the lower extremity. The pain symptoms usually occur initially during physical exertion, and later at rest. As PAD progresses, chronic ulceration and necrosis occur.
Professional societies such as the European Society of Cardiology (ESC) and the European Society of Vascular Medicine (ESVM) regularly publish guidelines for the diagnosis and treatment of PAD. Therapy of PAD consists of drug therapy for the purpose of cardiovascular risk reduction (lipid and blood pressure lowering drugs and anticoagulant drugs as well as therapy of diabetes mellitus). Another aspect in the event of disease progression is interventional angioplasty, in which the affected constriction in the leg arteries is dilated and, if necessary, treated with stents. Another important pillar is also structured and supervised gait training and, in general, an improvement in lifestyle with cessation of nicotine abuse and a healthy diet.
In particular, structured gait training, which should be performed at least three times a week for 30 to 60 minutes, is strongly recommended in the current ESVM and ESV guidelines. Studies showed that structured gait training can increase walking distance by 200% in 12 weeks in patients with claudication. Daily individual interval training of 60 minutes with 5- to 15-minute intervals also proved effective in increasing walking distance. This is to overcome the pain threshold of claudication while walking. Furthermore, evidence showed that gait training may be equivalent to endovascular interventions in terms of long-term outcomes.
The aim of this study is to analyze the applicability (usability) of a telehealth service as part of a potential disease management program for patients with peripheral arterial disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of "peripheral arterial occlusive disease" in, IIa and IIb (according to Fontaine).
- •Age between 18 and 80 years
- •Written informed consent
- •Smartphone with Android operating system
- •Understanding of how to use the tele-health service
排除标准
- •Patients with PAD stages I, III and IV (according to Fontaine)
- •Lack of compliance
- •Smartphone with non-Android operating system or incompatible software
结局指标
主要结局
Patient satisfaction with the telehealth service.
时间窗: At time point visit 3, which is 12 weeks after baseline
Study participants will undergo guided interviews measuring patient satisfaction with telehealth service.
次要结局
- Change of subjective limitations in the activities of daily living.(From baseline to visit 3, which is 12 weeks after baseline)
- Proportion of patients, who would be satisfied with the telehealth service if telephone calls would not be provided by a nurse during the programme(At time point visit 3, which is 12 weeks after baseline)
- Change of walking distances in the 6 minute walk test determined by the certified nursing staff in response to the telehealth service.(From baseline to visit 3, which is 12 weeks after baseline)
- Change of knowledge about peripheral arterial disease.(From baseline to visit 3, which is 12 weeks after baseline)
- Total number of performed 6 minute walk tests during the telehealth service.(At time point visit 3, which is 12 weeks after baseline)
- Differences of the walking distance in the same 6 minute walk test determined by the nursing staff compared the App.(At baseline and at visit 3, which is 12 weeks after baseline)
- Average steps per day during the telehealth service.(From baseline to visit 3, which is 12 weeks after baseline)
- Change of summed seconds in the "Time up and Go Test".(From baseline to visit 3, which is 12 weeks after baseline)
研究者
Günther Silbernagel
Assoc.-Prof. Priv.-Doz. Dr.med.univ. et scient.med.
Medical University of Graz