Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

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Description Module


Ignite Creation Date: 2025-12-26 @ 2:40 PM
Ignite Modification Date: 2025-12-26 @ 2:40 PM
NCT ID: NCT04384406
Brief Summary: Objectives This survey aims at reporting the immediate impact of the COVID-19 epidemic on outpatients followed in Physical and Rehabilitation Medicine (PRM). It focuses on the disruption of PRM healthcare services during the quarantine period in France between 2020 March 17th and May 11th and on its medical consequences. Method This observational study was conducted in the PRM department of a French University Hospital. Outpatients whose PRM medical consultation had been cancelled were contacted by phone between April 9th, 2020 and May 7th, 2020. A structured questionnaire was fulfilled for each patient. Demographical and medical data were recorded, including the disabling diseases motivating the PRM outpatients' follow-up. The necessity to perform an immediate phone consultation or to schedule an urgent consultation within the next 3 weeks constituted the main judgment criterion. Other recorded criteria were: the reason for this urgent need of a medical consultation, the access to other medical services during the quarantine period, the interruption of home-based rehabilitation services and its perceived consequences for the patients.
Detailed Description: The PRM Department of Montpellier University Hospital usually provides between 8500 and 9500 medical consultations/year. A total of 830 medical consultations have been cancelled during the lockdown for COVID-19 between March 17th, 2020, and May 11th, 2020. This survey was approved by the local Institutional Review Board (IRB accreditation number: 19871). Procedure Phone calls were performed by residents. These young doctors worked in the PRM Department for 4 months before the beginning of the outbreak and were used to the PRM medical practices of the senior practitioners. They received a special dedicated education before they start calling the patients. They fulfilled a structured questionnaire for each patient. Each resident was supervised by a senior MD. A personalized daily appointment was organized with the group of residents to check for difficulties in recording the data and to answer any question from them. Questionnaires were collected each day and data were daily implemented in a dedicated database. Data recorded Descriptive data concerning age, description of the underlying disease, and delay from the cancelled consultation were recorded at the beginning of the call. The main Judgment criterion is the necessity to schedule a medical consultation within the next 3 weeks: immediate telephone consultation for urgent but easy situations (like refilling a prescription or advising the patient), or short-term consultation within the next three weeks. Other patients have been proposed for a delayed consultation within the next 3 months. Secondary objectives are: 1/ the reason for this urgent need of a medical consultation within the next 3 weeks, 2/ the category of patients for whom this need was the most prevalent, 3/the relationship between the date of the cancelled consultation and the feeling of emergency for reprogramming it, 4/ the disruption of home-based or community-based rehabilitation and its consequences for patients, and 5/ the access to other medical services for those patients during the quarantine period.
Study: NCT04384406
Study Brief:
Protocol Section: NCT04384406