Mobile Unit Screening of Pathologies Associated With Chronic Diseases - Feasibility

• Register: ClinicalTrials.gov
• Last refreshed on: 25 May 2015
• Main ID: NCT02214056
• Date of registration: 07/08/2014
• Prospective Registration: Yes
• Primary sponsor: Centre Hospitalier Universitaire de Nimes
• Public title: Mobile Unit Screening of Pathologies Associated With Chronic Diseases - Feasibility DéProPAss
• Scientific title: Mobile Unit Screening of Pathologies Associated With Chronic Diseases - Part I Feasibility
• Date of first enrolment: February 2015
• Target sample size: 27
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02214056
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: David Costa, MD
• Affiliation: Centre Hospitalier Universitaire de Nîmes

Key inclusion & exclusion 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.



Age minimum: 50 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Obstructive Pulmonary Disease

Type II Diabetes

Atherosclerosis

Intervention(s)

Procedure: Mobile team exam

Other: Patient recruitment

Primary Outcome(s)

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

Secondary Outcome(s)

Observance: percentage of patients included that actually received the balance sheet [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)]

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)]

Average time required for the patient to fill out questionnaires [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)]

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)]

Percentage of GPs who participated in the study [Time Frame: Day of mobile team exam (day 0)]

Secondary ID(s)

LOCAL/2013/DC-02

2013-A01703-42

Source(s) of Monetary Support

Please refer to primary and secondary sponsors