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

Peripheral Arterial Disease Clinical Trial

Official title:

Randomized Trial of CONTECI Program: Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02762916
• Other study ID #: 18/14
• Status: Completed
• Phase: N/A
• First received: April 28, 2016
• Last updated: May 3, 2016
• Start date: May 2014
• Est. completion date: December 2015

Study information

• Verified date: May 2016
• Source: Consorci Sanitari del Maresme
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Personal Satisfaction
• Telemedicine

Intervention

Other:
• Selfmanage with the help of telemedicine program
The intervention group patients were not followed by the usual protocol, but it used the program CONTECI (and test different directions) to guide the patient monitoring. Both groups used antiplatelets and statines as usual protocol (these were not the interventions) We did not use drugs or device for the intervention, only a Telemedicine programme

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Sanitari del Maresme

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	satisfaction. Analogical scale 0-100. To compare the satisfaction in the new model control and the model before		12 months	Yes
Secondary	Clinical features. Pateint who turned to grade 3 or 4 of Le Fontaine classification, number of surgeries.	PAD grade 3 and 4, surgeries	6 and 12 months	Yes
Secondary	Health resources consumption: rate of Emergency visits, scheduled visits, extra visits, Mail per participant		6 and 12 months	No
Secondary	Quality of life. EuroQol5D were used. Change from baseline Quality of line at 12 months.		12 months	No