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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
Consorci Sanitari del Maresme
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Peripheral Arterial Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

    First Posted
    April 28, 2016
    Last Updated
    May 3, 2016
    Sponsor
    Consorci Sanitari del Maresme
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    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

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