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Completed

NCT Number: NCT02214056

Mobile Unit Screening of Pathologies Associated With Chronic Diseases - 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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Patient recruitment

Other

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.

Mobile team exam

Procedure

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 outcomes

  1. Percentage of eligible patients who actually received the mobile team exam

    Time frame: Day of mobile team exam (day 0)

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: DéProPAss

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 12, 2014
Registry last updated
May 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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