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Mobile Unit Screening of Pathologies Associated With Chronic Diseases - Feasibility (DéProPAss)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02214056
Recruitment Status : Completed
First Posted : August 12, 2014
Last Update Posted : May 6, 2015
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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.

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Type II Diabetes Atherosclerosis Other: Patient recruitment Procedure: Mobile team exam

Detailed Description:
The investigators secondary objectives include assessing patient and GP satisfaction in relation to the mobile screening team.

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Study Type : Observational
Actual Enrollment : 27 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mobile Unit Screening of Pathologies Associated With Chronic Diseases - Part I Feasibility
Study Start Date : February 2015
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
The study population

There is only one group in this study. Please see the inclusion/exclusion criteria.

Intervention: Patient recruitment Intervention: Mobile team exam

Other: Patient recruitment
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.

Procedure: Mobile team exam

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.





Primary Outcome Measures :
  1. Percentage of eligible patients who actually received the mobile team exam [ Time Frame: Day of mobile team exam (day 0) ]

Secondary Outcome Measures :
  1. Observance: percentage of patients included that actually received the balance sheet [ Time Frame: Day of mobile team exam (day 0) ]
  2. 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) ]
  3. Average per patient time necessary to carry out the mobile team exam [ Time Frame: Day of mobile team exam (day 0) ]
  4. Average time required for the patient to fill out questionnaires [ Time Frame: Day of mobile team exam (day 0) ]
  5. 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) ]
  6. Percentage of GPs who participated in the study [ Time Frame: Day of mobile team exam (day 0) ]
  7. Percentage of mobile team exams in which one or more comorbidities was discovered [ Time Frame: Day of mobile team exam (day 0) ]
  8. GP and patient acceptability of the mobile team exam [ Time Frame: Day of mobile team exam (day 0) ]
    Visual analog scales (ranging from 0 to 10) for access, delays, organization and satisfaction.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02214056


Locations
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France
Cabinet Médical - 47 rue de la République
Besseges, France, 30160
Centre de Santé Médical
Besseges, France, 30160
Centre médical des Olivettes
Ganges, France, 34190
Cabinet Médical - 5 rue Abbé Masson
La Grand Combe, France, 30110
Cabinet Médical - 154 Place de la Poste
Lasalle, France, 30460
Cabinet Médical - Les Glycines
Lasalle, France, 30460
Cabinet Médical - Pont de Grammal
Molières-sur-Cèze, France, 30410
Cabinet Médical - 9 rue Racine
Nîmes, France, 30000
Cabinet Médical - 15 rue du Lac
Quissac, France, 30260
Cabinet Médical - 7 bis avenue Rhin Danube
Sauve, France, 30610
Cabinet Médical - 36 place de l'Esplanade
St Ambroix, France, 30500
Centre Médical La Cantonnade
St Florent sur Auzonnet, France, 30960
Cabinét Médical - 9 rue Villeneuve
St Jean du Gard, France, 30270
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: David Costa, MD Centre Hospitalier Universitaire de Nîmes

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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02214056    
Other Study ID Numbers: LOCAL/2013/DC-02
2013-A01703-42 ( Other Identifier: RCB number )
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: April 2015
Keywords provided by Centre Hospitalier Universitaire de Nīmes:
mobile screening team
feasibility
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Atherosclerosis
Diabetes Mellitus, Type 2
Chronic Disease
Lung Diseases
Respiratory Tract Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases