Peripheral Arterial DiseaseNCT02762916
CONTECI Program: A New Way to Control Peripheral Arterial Disease Using New Technologies
A study testing Selfmanage with the help of telemedicine program in people with Peripheral Arterial Disease and Personal Satisfaction, run by Consorci Sanitari del Maresme.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Personal Satisfaction, Telemedicine
- What is being tested?
- Selfmanage with the help of telemedicine program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with confirmed PAD
- Over 18 years old
- Informed Consent
- Internet Access (patient or family)
- Spanish or Catalan fluidity
Who cannot join
- Cognitive impairment
- Previous patency arterial surgery
- Sever chronic obstructive pulmonary disease (GOLD III/ IV)
- Patients with decreased survival of 12 months
About this study
Official title: 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.
- Being tested
- Selfmanage with the help of telemedicine program
- Medical subject headings
- Peripheral Arterial Disease, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selfmanage with the help of telemedicine programOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
satisfaction. Analogical scale 0-100. To compare the satisfaction in the new model control and the model before
Measured: 12 months
Secondary outcomes (3)
Clinical features. Pateint who turned to grade 3 or 4 of Le Fontaine classification, number of surgeries.
PAD grade 3 and 4, surgeries
Measured: 6 and 12 months
Health resources consumption: rate of Emergency visits, scheduled visits, extra visits, Mail per participant
Measured: 6 and 12 months
Quality of life. EuroQol5D were used. Change from baseline Quality of line at 12 months.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startMay 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari del Maresme
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762916
- Sponsor's protocol ID
- 18/14
- Status last verified
- May 2016
- First submitted
- 28 Apr 2016
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of CONTECI Program: Pilot Study
- ClinicalTrials.gov ID
- NCT02762916
- Acronym / sponsor ID
- 18/14
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Consorci Sanitari del MaresmeUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1- Telemedicine arm | Experimental | Other: Selfmanage with the help of telemedicine programThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with confirmed PAD
- Over 18 years old
- Informed Consent
- Internet Access (patient or family)
- Spanish or Catalan fluidity
Key exclusion criteria (4 listed)
- Cognitive impairment
- Previous patency arterial surgery
- Sever chronic obstructive pulmonary disease (GOLD III/ IV)
- Patients with decreased survival of 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selfmanage with the help of telemedicine programThe 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 | Other | 1- Telemedicine arm |
Primary outcome
satisfaction. Analogical scale 0-100. To compare the satisfaction in the new model control and the model before
Time frame: 12 months
3 secondary outcomes
Clinical features. Pateint who turned to grade 3 or 4 of Le Fontaine classification, number of surgeries.
Time frame: 6 and 12 months
Health resources consumption: rate of Emergency visits, scheduled visits, extra visits, Mail per participant
Time frame: 6 and 12 months
Quality of life. EuroQol5D were used. Change from baseline Quality of line at 12 months.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Selfmanage with the help of telemedicine program in people with Peripheral Arterial Disease and Personal Satisfaction, run by Consorci Sanitari del Maresme.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
satisfaction. Analogical scale 0-100. To compare the satisfaction in the new model control and the model before (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2016.