Mobile Unit Screening of Pathologies Associated With Chronic Diseases - Feasibility
DéProPAss
2 other identifiers
observational
27
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2015
Shorter than P25 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2014
CompletedFirst Posted
Study publicly available on registry
August 12, 2014
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedMay 6, 2015
April 1, 2015
2 months
August 7, 2014
May 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of eligible patients who actually received the mobile team exam
Day of mobile team exam (day 0)
Secondary Outcomes (8)
Observance: percentage of patients included that actually received the balance sheet
Day of mobile team exam (day 0)
Time in days between making the appointment by the general practitioner and the mobile team exam
Day of mobile team exam (day 0)
Average per patient time necessary to carry out the mobile team exam
Day of mobile team exam (day 0)
Average time required for the patient to fill out questionnaires
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
Day of mobile team exam (day 0)
- +3 more secondary outcomes
Study Arms (1)
The study population
There is only one group in this study. Please see the inclusion/exclusion criteria. Intervention: Patient recruitment Intervention: Mobile team exam
Interventions
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.
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- The patient is participating in another 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Cabinet Médical - 47 rue de la République
Bessèges, 30160, France
Centre de Santé Médical
Bessèges, 30160, France
Centre médical des Olivettes
Ganges, 34190, France
Cabinet Médical - 5 rue Abbé Masson
La Grand-Combe, 30110, France
Cabinet Médical - 154 Place de la Poste
Lasalle, 30460, France
Cabinet Médical - Les Glycines
Lasalle, 30460, France
Cabinet Médical - Pont de Grammal
Molières-sur-Cèze, 30410, France
Cabinet Médical - 9 rue Racine
Nîmes, 30000, France
Cabinet Médical - 15 rue du Lac
Quissac, 30260, France
Cabinet Médical - 36 place de l'Esplanade
Saint-Ambroix, 30500, France
Centre Médical La Cantonnade
Saint-Florent-sur-Auzonnet, 30960, France
Cabinét Médical - 9 rue Villeneuve
Saint-Jean-du-Gard, 30270, France
Cabinet Médical - 7 bis avenue Rhin Danube
Sauve, 30610, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Costa, MD
Centre Hospitalier Universitaire de Nîmes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2014
First Posted
August 12, 2014
Study Start
February 1, 2015
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
May 6, 2015
Record last verified: 2015-04