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Clinical Trials/NCT02762916
NCT02762916
Completed
N/A

Randomized Trial of CONTECI Program: Pilot Study

Consorci Sanitari del Maresme0 sites150 target enrollmentMay 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Peripheral Arterial Disease
Sponsor
Consorci Sanitari del Maresme
Enrollment
150
Primary Endpoint
satisfaction. Analogical scale 0-100. To compare the satisfaction in the new model control and the model before
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
December 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Consorci Sanitari del Maresme
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

satisfaction. Analogical scale 0-100. To compare the satisfaction in the new model control and the model before

Time Frame: 12 months

Secondary Outcomes

  • 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)
  • Quality of life. EuroQol5D were used. Change from baseline Quality of line at 12 months.(12 months)

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