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

NCT02762916 | Completed DMC

• 1 other identifier: 18/14
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peripheral Arterial Disease; Personal Satisfaction; Telemedicine

Outcome Measures

Primary Outcomes (1)

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

  12 months

Secondary Outcomes (3)

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

Study Arms (2)

1- Telemedicine arm

EXPERIMENTAL

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

2- Control arm

NO INTERVENTION

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.

Interventions

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

1- Telemedicine arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with confirmed PAD
• Over 18 years old
• Informed Consent
• Internet Access (patient or family)
• Spanish or Catalan fluidity

You may not qualify if:

• Cognitive impairment
• Previous patency arterial surgery
• Sever chronic obstructive pulmonary disease (GOLD III/ IV)
• Patients with decreased survival of 12 months

Sponsors & Collaborators

• Consorci Sanitari del Maresme: lead

MeSH Terms

Conditions

Peripheral Arterial Disease; Personal Satisfaction

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: May 5, 2016
• Study Start: May 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 5, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share