Chronic DisablingHandicallNCT04384406
COVID-19 Outbreak Consequences for Outpatients Followed in PRM
An observational study of Chronic Disabling and COVID-19, run by University Hospital, Montpellier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disabling, COVID-19
- How many people
- 467 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2020to 9 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients from an university hospital PRM Department
Who may be able to join
- All outpatients whose medical appointment had been cancelled between March 17th and May 11th 2020 were contacted by phone between April 9th and May 7th 2020.
Who cannot join
- Patients who had spontaneously called the hospital to ask for reprogramming the cancelled consultation before being contacted
- Patients followed by the three senior MD who preferred to call patients by themselves and who didn't want to fulfill the questionnaires for personnel reasons
- Patient who didn't answer after three phone calls
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Consequences of the Abrupt Interruption of Physical and Rehabilitation Medicine Consultations During the Quarantine Period in France Between 2020 March 17th and May 11th
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.
Read the 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.
- Conditions
- Chronic Disabling, COVID-19
- Keywords
- Medical consultation, Disability, Loss of chance, Physical and Rehabilitation medicine, Home-based rehabilitation, Telehealth
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients necessitating the scheduling of a medical consultation
Proportion of patients necessitating the scheduling of a medical consultation within the next 3 weeks
Measured: 1 day (Time of the phone call)
Secondary outcomes (3)
the reason for this urgent need of a medical consultation
the reason for this urgent need of a medical consultation
Measured: 1 day (Time of the phone call)
the access to other medical services during the quarantine period
the access to other medical services during the quarantine period
Measured: 1 day (Time of the phone call)
the interruption of home-based rehabilitation services
the interruption of home-based rehabilitation services and its perceived consequences for the patients
Measured: 1 day (Time of the phone call)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start1 Apr 2020
- Primary completion1 May 2020
- Study completion9 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DisablingStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 467 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle LAFFONT, Professor, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384406
- Sponsor's protocol ID
- RECHMPL20_0262
- Acronym
- Handicall
- Status last verified
- May 2020
- First submitted
- 10 May 2020
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Consequences of the Abrupt Interruption of Physical and Rehabilitation Medicine Consultations During the Quarantine Period in France Between 2020 March 17th and May 11th
- ClinicalTrials.gov ID
- NCT04384406
- Acronym / sponsor ID
- Handicall / RECHMPL20_0262
- Conditions
- Chronic Disabling, COVID-19
- Keywords
- Medical consultation, Disability, Loss of chance, Physical and Rehabilitation medicine, Home-based rehabilitation, Telehealth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 467 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 9 May 2020 (actual)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients from an university hospital PRM Department
Key inclusion criteria (1 listed)
- All outpatients whose medical appointment had been cancelled between March 17th and May 11th 2020 were contacted by phone between April 9th and May 7th 2020.
Key exclusion criteria (3 listed)
- Patients who had spontaneously called the hospital to ask for reprogramming the cancelled consultation before being contacted
- Patients followed by the three senior MD who preferred to call patients by themselves and who didn't want to fulfill the questionnaires for personnel reasons
- Patient who didn't answer after three phone calls
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients necessitating the scheduling of a medical consultation
Time frame: 1 day (Time of the phone call)
Proportion of patients necessitating the scheduling of a medical consultation within the next 3 weeks
3 secondary outcomes
the reason for this urgent need of a medical consultation
Time frame: 1 day (Time of the phone call)
the access to other medical services during the quarantine period
Time frame: 1 day (Time of the phone call)
the interruption of home-based rehabilitation services
Time frame: 1 day (Time of the phone call)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle LAFFONT, Professor principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Disabling and COVID-19, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients necessitating the scheduling of a medical consultation (time frame: 1 day (Time of the phone call)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020.