CONTECI Program: A New Way to Control Peripheral Arterial Disease Using New Technologies

Not Applicable

Completed

• Conditions: Personal Satisfaction; Telemedicine; Peripheral Arterial Disease

• Registration Number: NCT02762916
• Lead Sponsor: Consorci Sanitari del Maresme

Brief Summary

The current increase in chronic diseases calls for changes to the health system. It is necessary to promote expert patient in chronic disease. The expansion of new technologies gives us new tools to face new challenges, providing efficiency, expertise and autonomy. The characteristics of peripheral arterial disease make possible to promote expert patient and the self-management. In order to bring these concepts together the telemedicine program was created to promote expert patient for increasing the quality of life and satisfaction of patients and improving the efficiency of the health system.

Methods: Randomized clinical trial on patients with peripheral arterial disease in intermittent claudication grade. They were randomized into two groups: intervention arm (IA) using CONTECI program for self-managing and control arm (CA), followed as usual vascular visits.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Study First Submitted: 2016-04-28
• Status Verified: 2016-05
• Study First Submitted QC: 2016-05-03
• Last Update Submitted: 2016-05-03
• Study First Posted: 2016-05-05
• Last Update Posted: 2016-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patient with confirmed PAD
• Over 18 years old
• Informed Consent
• Internet Access (patient or family)
• Spanish or Catalan fluidity

Exclusion Criteria

• Cognitive impairment
• Previous patency arterial surgery
• Sever chronic obstructive pulmonary disease (GOLD III/ IV)
• Patients with decreased survival of 12 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
satisfaction. Analogical scale 0-100. To compare the satisfaction in the new model control and the model before	12 months

Secondary Outcome Measures

Name	Time	Method
Health resources consumption: rate of Emergency visits, scheduled visits, extra visits, Mail per participant	6 and 12 months
Clinical features. Pateint who turned to grade 3 or 4 of Le Fontaine classification, number of surgeries.	6 and 12 months	PAD grade 3 and 4, surgeries
Quality of life. EuroQol5D were used. Change from baseline Quality of line at 12 months.	12 months