CONTECI Program: A New Way to Control Peripheral Arterial Disease Using New Technologies
Primary Purpose
Peripheral Arterial Disease, Personal Satisfaction, Telemedicine
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Selfmanage with the help of telemedicine program
Sponsored by
About this trial
This is an interventional supportive care trial for Peripheral Arterial Disease
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1- Telemedicine arm
2- Control arm
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
satisfaction. Analogical scale 0-100. To compare the satisfaction in the new model control and the model before
Secondary Outcome Measures
Clinical features. Pateint who turned to grade 3 or 4 of Le Fontaine classification, number of surgeries.
PAD grade 3 and 4, surgeries
Health resources consumption: rate of Emergency visits, scheduled visits, extra visits, Mail per participant
Quality of life. EuroQol5D were used. Change from baseline Quality of line at 12 months.
Full Information
NCT ID
NCT02762916
First Posted
April 28, 2016
Last Updated
May 3, 2016
Sponsor
Consorci Sanitari del Maresme
1. Study Identification
Unique Protocol Identification Number
NCT02762916
Brief Title
CONTECI Program: A New Way to Control Peripheral Arterial Disease Using New Technologies
Official Title
Randomized Trial of CONTECI Program: Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Consorci Sanitari del Maresme
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Personal Satisfaction, Telemedicine
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1- Telemedicine arm
Arm Type
Experimental
Arm Description
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.
Arm Title
2- Control arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Selfmanage with the help of telemedicine program
Intervention Description
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 Outcome Measure Information:
Title
satisfaction. Analogical scale 0-100. To compare the satisfaction in the new model control and the model before
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Clinical features. Pateint who turned to grade 3 or 4 of Le Fontaine classification, number of surgeries.
Description
PAD grade 3 and 4, surgeries
Time Frame
6 and 12 months
Title
Health resources consumption: rate of Emergency visits, scheduled visits, extra visits, Mail per participant
Time Frame
6 and 12 months
Title
Quality of life. EuroQol5D were used. Change from baseline Quality of line at 12 months.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CONTECI Program: A New Way to Control Peripheral Arterial Disease Using New Technologies
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