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

Sponsor

Consorci Sanitari del Maresme (Other)

Overall Status

Completed

CT.gov ID

NCT02762916

Collaborator

(none)

150

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease Personal Satisfaction Telemedicine	Other: Selfmanage with the help of telemedicine program	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Randomized Trial of CONTECI Program: Pilot Study

Study Start Date :

May 1, 2014

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

satisfaction. Analogical scale 0-100. To compare the satisfaction in the new model control and the model before [12 months]

Secondary Outcome Measures

Clinical features. Pateint who turned to grade 3 or 4 of Le Fontaine classification, number of surgeries. [6 and 12 months]
PAD grade 3 and 4, surgeries
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Consorci Sanitari del Maresme

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Consorci Sanitari del Maresme

ClinicalTrials.gov Identifier:

NCT02762916

Other Study ID Numbers:

18/14

First Posted:

May 5, 2016

Last Update Posted:

May 5, 2016

Last Verified:

May 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Peripheral Arterial Disease

Peripheral Vascular Diseases

Study Results

No Results Posted as of May 5, 2016