A Usability Study of a Tele-health Service for Patients With Peripheral Arterial Disease.
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.

      A prospective monocentric pilot study will be conducted at the clinical department of
      angiology.

      The study duration per participant is 90 (±14) days and is divided into 2 observation phases.
      In phase 1, there will be supervision by a certified nurse and the telehealth service app,
      and in phase 2, there will be only singular use of the app without contact by the certified
      nurse.

      The Declaration of Helsinki (as amended from time to time) and the guidelines of "Good
      Clinical Practice" were taken into account in the conduct and also the planning of the study.

      Furthermore, the framework guideline for the "IT infrastructure in the application of
      telemonitoring" was used for the planning of the study.

      According to the manufacturer's manuals, the pedometers AS80/AS97/AS99 from the company
      Beurer are not medical devices. The app serves as a diary for patients and is not a Clinical
      Decision Support System. The "User's Manual PAD Stepping" is included with the study
      material.

      Reference Projects:

      The DMS app system is also already being used in routine care in the "Herzmobil" project in
      Styria and Tyrol. Here, patients with chronic heart failure are cared for.

      The use of the DMS app is currently also being used in two other studies. These are
      observational studies that are not subject to the Medical Devices Act. Both projects have a
      positive ethics vote and are listed under the following titles:

        -  Telemedical follow-up of hospitalized patients with coronavirus disease-2019 (COVID-19)
           DRKS ID of the study: DRKS00022244.

        -  Building a training database of voice data recordings and body weight trajectories in
           hemodialysis patients for algorithm development.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with IIa and IIb PAD at the Department of Angiology at the
        LKH-University Hospital Graz.
      
Keywords: Peripheral Arterial Disease; Walking exercise; Tele-health Service; Disease Management Program; Preventive Medicine; Integrated care; Vascular Medicine