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

Randomized Trial of CONTECI Program: Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02762916
Enrollment
150
Registered
2016-05-05
Start date
2014-05-31
Completion date
2015-12-31
Last updated
2016-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease, Personal Satisfaction, Telemedicine

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.

Interventions

OTHERSelfmanage 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

Sponsors

Consorci Sanitari del Maresme
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
satisfaction. Analogical scale 0-100. To compare the satisfaction in the new model control and the model before12 months

Secondary

MeasureTime frameDescription
Clinical features. Pateint who turned to grade 3 or 4 of Le Fontaine classification, number of surgeries.6 and 12 monthsPAD grade 3 and 4, surgeries
Health resources consumption: rate of Emergency visits, scheduled visits, extra visits, Mail per participant6 and 12 months
Quality of life. EuroQol5D were used. Change from baseline Quality of line at 12 months.12 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026