Mobile Unit Screening of Pathologies Associated With Chronic Diseases - Feasibility

Chronic Obstructive Pulmonary Disease Clinical Trial

— DéProPAss  

Official title:

Mobile Unit Screening of Pathologies Associated With Chronic Diseases - Part I Feasibility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02214056
• Other study ID #: LOCAL/2013/DC-02
• Secondary ID: 2013-A01703-42
• Status: Completed
• Phase: N/A
• First received: August 7, 2014
• Last updated: May 5, 2015
• Start date: February 2015
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Observational

Clinical 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis
• Chronic Disease
• Chronic Obstructive Pulmonary Disease
• Diabetes Mellitus, Type 2
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Type II Diabetes

Intervention

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 ß2-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.

Locations

Country	Name	City	State
France	Cabinet Médical - 47 rue de la République	Besseges
France	Centre de Santé Médical	Besseges
France	Centre médical des Olivettes	Ganges
France	Cabinet Médical - 5 rue Abbé Masson	La Grand Combe
France	Cabinet Médical - 154 Place de la Poste	Lasalle
France	Cabinet Médical - Les Glycines	Lasalle
France	Cabinet Médical - Pont de Grammal	Molières-sur-Cèze
France	Cabinet Médical - 9 rue Racine	Nîmes
France	Cabinet Médical - 15 rue du Lac	Quissac
France	Cabinet Médical - 7 bis avenue Rhin Danube	Sauve
France	Cabinet Médical - 36 place de l'Esplanade	St Ambroix
France	Centre Médical La Cantonnade	St Florent sur Auzonnet
France	Cabinét Médical - 9 rue Villeneuve	St Jean du Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of eligible patients who actually received the mobile team exam		Day of mobile team exam (day 0)	No
Secondary	Observance: percentage of patients included that actually received the balance sheet		Day of mobile team exam (day 0)	No
Secondary	Time in days between making the appointment by the general practitioner and the mobile team exam		Day of mobile team exam (day 0)	No
Secondary	Average per patient time necessary to carry out the mobile team exam		Day of mobile team exam (day 0)	No
Secondary	Average time required for the patient to fill out questionnaires		Day of mobile team exam (day 0)	No
Secondary	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)	No
Secondary	Percentage of GPs who participated in the study		Day of mobile team exam (day 0)	No
Secondary	Percentage of mobile team exams in which one or more comorbidities was discovered		Day of mobile team exam (day 0)	No
Secondary	GP and patient acceptability of the mobile team exam	Visual analog scales (ranging from 0 to 10) for access, delays, organization and satisfaction.	Day of mobile team exam (day 0)	No