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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Atherosclerosis; Type II Diabetes
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of eligible patients who actually received the mobile team exam	Day of mobile team exam (day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Percentage of GPs who participated in the study		Day of mobile team exam (day 0)
Percentage of mobile team exams in which one or more comorbidities was discovered		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.	Day of mobile team exam (day 0)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: August 7, 2014
• First Submitted That Met QC Criteria: August 8, 2014
• First Posted (Estimate): August 12, 2014

Study Record Updates

• Last Update Posted (Estimate): May 6, 2015
• Last Update Submitted That Met QC Criteria: May 5, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: feasibility; mobile screening team
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Respiratory Tract Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Lung Diseases; Endocrine System Diseases; Disease Attributes; Diabetes Mellitus; Diabetes Mellitus, Type 2; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Chronic Disease; Atherosclerosis
• Other Study ID Numbers: LOCAL/2013/DC-02; 2013-A01703-42 (Other Identifier: RCB number)