Skip to main content
OpenTrials
Completed

NCT Number: NCT02762916

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Behavior Cardiovascular Diseases Peripheral Vascular Diseases Personal Satisfaction Telemedicine Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Selfmanage with the help of telemedicine program

Other

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

Primary outcomes

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

    Time frame: 12 months

Secondary outcomes

  1. Clinical features. Pateint who turned to grade 3 or 4 of Le Fontaine classification, number of surgeries.

    Time frame: 6 and 12 months

    PAD grade 3 and 4, surgeries

  2. Health resources consumption: rate of Emergency visits, scheduled visits, extra visits, Mail per participant

    Time frame: 6 and 12 months

  3. Quality of life. EuroQol5D were used. Change from baseline Quality of line at 12 months.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Consorci Sanitari del Maresme

Other

Registry information

Official study title

Randomized Trial of CONTECI Program: Pilot Study

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 5, 2016
Registry last updated
May 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.