A Usability Study of a Tele-health Service for Patients With Peripheral Arterial Disease.

NCT05619835 | Completed

• 1 other identifier: 1566-2021
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Arterial Disease

Keywords

Peripheral Arterial Disease; Walking exercise; Tele-health Service; Disease Management Program; Preventive Medicine; Integrated care; Vascular Medicine

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction with the telehealth service.

  Study participants will undergo guided interviews measuring patient satisfaction with telehealth service.

  At time point visit 3, which is 12 weeks after baseline

Secondary Outcomes (8)

• 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 subjective limitations in the activities of daily living.

  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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients with PAD stages I, III and IV (according to Fontaine)
• Lack of compliance
• Smartphone with non-Android operating system or incompatible software

Sponsors & Collaborators

• Medical University of Graz: lead
• AIT Austrian Institute of Technology GmbH: collaborator

Study Sites (1)

Medical University of Graz

Graz, Styria, 8036, Austria

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.-Prof. Priv.-Doz. Dr.med.univ. et scient.med.

Study Record Dates

• First Submitted: May 7, 2022
• First Posted: November 17, 2022
• Study Start: November 11, 2022
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: November 1, 2023

Record last verified: 2023-10

Locations

AU (1)