Chronic Obstructive Pulmonary DiseaseDéProPAssNCT02214056
Mobile Unit Screening of Pathologies Associated With Chronic Diseases - Feasibility
An observational study of Chronic Obstructive Pulmonary Disease and Type II Diabetes, run by Centre Hospitalier Universitaire de Nīmes at 13 sites in France.
Trial summary
The main objective of this study is to assess the feasibility of standardized screening for comorbidities among patients with one or more of three chronic diseases (diabetes, COPD, atherosclerosis) by a mobile unit at times and localities under-served by health actors. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Type II Diabetes, Atherosclerosis
- What is being tested?
- Patient recruitment and Mobile team exam
- Type of treatment
- Surgery or procedure
- How many people
- 27 participants
- Where
- 13 sitesFrance
- Study dates
- Feb 2015to Apr 2015
- Phase
- Observational
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients at least 50 years of age with a chronic disease (COPD, Type II diabetes, atherosclerosis) recruited by one of the GP investigators.
Who may be able to join
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient has one or more of the following three diseases: (1) chronic obstructive pulmonary disease (COPD); (2) type II diabetes; (3) atherosclerosis.
Who cannot join
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- There is a need to take urgent therapeutic care in the opinion of the general practitioner
- The patient has received within the past year, a full examination including Doppler assessment of supra-aortic arteries, abdominal aorta and lower limbs; the patient has received a measure of the ankle-brachial index at the toe.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
Cabinet Médical - 47 rue de la République
Bessèges, 30160
Centre de Santé Médical
Bessèges, 30160
Centre médical des Olivettes
Ganges, 34190
Cabinet Médical - 5 rue Abbé Masson
La Grand-Combe, 30110
Cabinet Médical - 154 Place de la Poste
Lasalle, 30460
Cabinet Médical - Les Glycines
Lasalle, 30460
Cabinet Médical - Pont de Grammal
Molières-sur-Cèze, 30410
Cabinet Médical - 9 rue Racine
Nîmes, 30000
Cabinet Médical - 15 rue du Lac
Quissac, 30260
Cabinet Médical - 36 place de l'Esplanade
Saint-Ambroix, 30500
Centre Médical La Cantonnade
Saint-Florent-sur-Auzonnet, 30960
Cabinét Médical - 9 rue Villeneuve
Saint-Jean-du-Gard, 30270
Cabinet Médical - 7 bis avenue Rhin Danube
Sauve, 30610
About this study
Official title: Mobile Unit Screening of Pathologies Associated With Chronic Diseases - Part I Feasibility
The main objective of this study is to assess the feasibility of standardized screening for comorbidities among patients with one or more of three chronic diseases (diabetes, COPD, atherosclerosis) by a mobile unit at times and localities under-served by health actors.
Read the detailed description
The investigators secondary objectives include assessing patient and GP satisfaction in relation to the mobile screening team.
- Being tested
- Patient recruitment, Mobile team exam
- Keywords
- mobile screening team, feasibility
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Diabetes Mellitus, Type 2, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient recruitmentOther
Participating general practitioners (GPs) will inform and recruit participants from among regular patient consults. Using the provided web tools, GPs will organize a visit with the mobile team that fits the needs of the patient.
Mobile team examProcedure or surgery
Each patient enrolled will receive a standardized assessment in one locality, made in about two hours, and comprising:
questionnaire responses, a complete physical exam, a 12-lead ECG, spirometry before and after administration of β2-agonists, an arterial Doppler ultrasound (carotid and abdominal), ankle-brachial index (systolic pressure at the toe).
At the end of two hours, each patient will evaluate their satisfaction using a survey of acceptability and leave with a full report to the attention of their general practitioner (copy sent to Physician if needed) detailing the results of the different examinations.
| Study group | Role | What they receive |
|---|---|---|
| The study population | There is only one group in this study. Please see the inclusion/exclusion criteria.
Intervention: Patient recruitment Intervention: Mobile team exam Receives: Other: Patient recruitment; Procedure: Mobile team exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of eligible patients who actually received the mobile team exam
Measured: Day of mobile team exam (day 0)
Secondary outcomes (8)
Observance: percentage of patients included that actually received the balance sheet
Measured: Day of mobile team exam (day 0)
Time in days between making the appointment by the general practitioner and the mobile team exam
Measured: Day of mobile team exam (day 0)
Average per patient time necessary to carry out the mobile team exam
Measured: Day of mobile team exam (day 0)
Average time required for the patient to fill out questionnaires
Measured: Day of mobile team exam (day 0)
Percentage of complete mobile team exams, that is to say in which all the data and all the variables have been collected and interpreted
Measured: Day of mobile team exam (day 0)
Percentage of GPs who participated in the study
Measured: Day of mobile team exam (day 0)
Percentage of mobile team exams in which one or more comorbidities was discovered
Measured: Day of mobile team exam (day 0)
GP and patient acceptability of the mobile team exam
Visual analog scales (ranging from 0 to 10) for access, delays, organization and satisfaction.
Measured: Day of mobile team exam (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startFeb 2015
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Costa, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214056
- Sponsor's protocol ID
- LOCAL/2013/DC-02
- Other IDs
- 2013-A01703-42
- Acronym
- DéProPAss
- Status last verified
- Apr 2015
- First submitted
- 7 Aug 2014
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Unit Screening of Pathologies Associated With Chronic Diseases - Part I Feasibility
- ClinicalTrials.gov ID
- NCT02214056
- Acronym / sponsor ID
- DéProPAss / LOCAL/2013/DC-02
- Keywords
- mobile screening team, feasibility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 12 Aug 2014 (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 main objective of this study is to assess the feasibility of standardized screening for comorbidities among patients with one or more of three chronic diseases (diabetes, COPD, atherosclerosis) by a mobile unit at times and localities under-served by health actors.
Detailed description
The investigators secondary objectives include assessing patient and GP satisfaction in relation to the mobile screening team.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population | – | Other: Patient recruitment, Procedure: Mobile team examThere is only one group in this study. Please see the inclusion/exclusion criteria. Intervention: Patient recruitment Intervention: Mobile team exam |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients at least 50 years of age with a chronic disease (COPD, Type II diabetes, atherosclerosis) recruited by one of the GP investigators.
Key inclusion criteria (3 listed)
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient has one or more of the following three diseases: (1) chronic obstructive pulmonary disease (COPD); (2) type II diabetes; (3) atherosclerosis.
Key exclusion criteria (7 listed)
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
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 |
|---|---|---|
| Patient recruitmentParticipating general practitioners (GPs) will inform and recruit participants from among regular patient consults. Using the provided web tools, GPs will organize a visit with the mobile team that fits the needs of the patient. | Other | The study population |
| Mobile team examEach patient enrolled will receive a standardized assessment in one locality, made in about two hours, and comprising: questionnaire responses, a complete physical exam, a 12-lead ECG, spirometry before and after administration of β2-agonists, an arterial Doppler ultrasound (carotid and abdominal), ankle-brachial index (systolic pressure at the toe). At the end of two hours, each patient will evaluate their satisfaction using a survey of acceptability and leave with a full report to the attention of their general practitioner (copy sent to Physician if needed) detailing the results of the different examinations. | Procedure or surgery | The study population |
Primary outcome
Percentage of eligible patients who actually received the mobile team exam
Time frame: Day of mobile team exam (day 0)
8 secondary outcomes
Observance: percentage of patients included that actually received the balance sheet
Time frame: Day of mobile team exam (day 0)
Time in days between making the appointment by the general practitioner and the mobile team exam
Time frame: Day of mobile team exam (day 0)
Average per patient time necessary to carry out the mobile team exam
Time frame: Day of mobile team exam (day 0)
Average time required for the patient to fill out questionnaires
Time frame: Day of mobile team exam (day 0)
Percentage of complete mobile team exams, that is to say in which all the data and all the variables have been collected and interpreted
Time frame: Day of mobile team exam (day 0)
Percentage of GPs who participated in the study
Time frame: Day of mobile team exam (day 0)
Percentage of mobile team exams in which one or more comorbidities was discovered
Time frame: Day of mobile team exam (day 0)
GP and patient acceptability of the mobile team exam
Time frame: Day of mobile team exam (day 0)
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 6 May 2015.
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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.
David Costa, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Type II Diabetes, run by Centre Hospitalier Universitaire de Nīmes at 13 sites in France.
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 3 inclusion and 7 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 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Percentage of eligible patients who actually received the mobile team exam (time frame: Day of mobile team exam (day 0)). 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 6 May 2015.