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

Randomized Trial of CONTECI Program: Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease; Telemedicine; Personal Satisfaction
• Intervention / Treatment: Other: Selfmanage with the help of telemedicine program

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1- Telemedicine arm; The intervention arm (IA), telehealth control, were followed up by himself helped by CONTECI program. They have to use every three months and if somethings was wrong the patient have to send mail to the doctor. The intervention consisted to use the CONTECI program (included test) for the following of the patients.	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
No Intervention: 2- Control arm; The Control Arm (CA) were followed up as usual every 6 months in outpatient vascular visits in the clinical hospital. If some patient have a complications or and emergency they have to do usual protocol, go to primary care or emergency.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
satisfaction. Analogical scale 0-100. To compare the satisfaction in the new model control and the model before	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Health resources consumption: rate of Emergency visits, scheduled visits, extra visits, Mail per participant		6 and 12 months
Quality of life. EuroQol5D were used. Change from baseline Quality of line at 12 months.		12 months

Collaborators and Investigators

• Sponsor: Consorci Sanitari del Maresme

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: April 28, 2016
• First Submitted That Met QC Criteria: May 3, 2016
• First Posted (Estimate): May 5, 2016

Study Record Updates

• Last Update Posted (Estimate): May 5, 2016
• Last Update Submitted That Met QC Criteria: May 3, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 18/14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO