Disabilities PhysicalINFRANCT04991558
Feasibility and Effectiveness of a Coordinated Healthcare Circuit Dedicated to Patients With Handicap
An observational study of Disabilities Physical and Disabilities Mental, run by Groupe Hospitalier Mutualiste de Grenoble at 1 site in France.
Trial summary
France currently has more than 10 million disabled people, including 3 millions who could be better treated. In fact, people with disabilities face many obstacles in accessing care and receiving appropriate support (physical access to certain locations, communication...). Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Disabilities Physical, Disabilities Mental
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 3 Sep 2020to 1 Sep 2022
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with physical or mental disability, planned for surgical procedure and requiring an adaptation of their healthcare circuit
Who may be able to join
- 13 years old or more
- Physical or mental disability, according to french law n°2005-102 of February 11th, 2005
- Requiring an adaptation of the healthcare circuit
- Indication of a planned surgical procedure
Who cannot join
- Outpatient
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Single-center Observational Study to Assess the Feasibility and Evaluate the Effectiveness of a Coordinated Healthcare Circuit Dedicated to Patients With Mental and Physical Disabilities Undergoing Planned Surgery
France currently has more than 10 million disabled people, including 3 millions who could be better treated. In fact, people with disabilities face many obstacles in accessing care and receiving appropriate support (physical access to certain locations, communication...). Difficulties are also encountered by the healthcare staff, leading to often heterogeneous practices in health establishments.
The INFRA health circuit has been set up at the "Groupe Hospitalier Mutualiste de Grenoble" since June 2018 according to the guidelines published by the French High Authority for Health (HAS) on improving professional practices "Reception, support and organization of care in health establishments for people in situation of handicap "of July 2017. The INFRA nurse collects and anticipates the necessary adaptations for the patient's stay, in conjunction with their caregivers (whether family or institutional). They are an interface with other healthcare professionals to adapt care procedures and protocols (body care, feeding methods, pain management, drug management) to the patient's disability. Before hospitalization and until the patient is discharged, the INFRA nurse transmits to the personnel involved all the information necessary for the proper continuation of care. In addition to legal and regulatory obligations, the INFRA nurse ensures the effective accessibility of the establishment's facilities and premises, and helps maintaining patient autonomy.
The INFRA study is an observational study aimed at assessing the feasibility of the INFRA health circuit and evaluating the benefit for the patients and the healthcare staff.
- Conditions
- Disabilities Physical, Disabilities Mental
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who followed the entirety of INFRA circuit
Measured: At discharge, assessed up to 4 weeks
Secondary outcomes (4)
Type of pain evaluation scale selected by the INFRA nurse
Measured: enrollment
Number of healthcare adaptations implemented during hospitalization
Measured: At discharge, assessed up to 4 weeks
Satisfaction of patients and caregivers
Satisfaction survey answered by patients and caregivers
Measured: At discharge, assessed up to 4 weeks
Satisfaction of healthcare staff
Satisfaction survey answered by healthcare staff
Measured: At discharge, assessed up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start3 Sep 2020
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disabilities PhysicalStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Mutualiste de Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04991558
- Sponsor's protocol ID
- 2019/09-ERA-GHMG
- Acronym
- INFRA
- Status last verified
- Mar 2023
- First submitted
- 29 Dec 2020
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-center Observational Study to Assess the Feasibility and Evaluate the Effectiveness of a Coordinated Healthcare Circuit Dedicated to Patients With Mental and Physical Disabilities Undergoing Planned Surgery
- ClinicalTrials.gov ID
- NCT04991558
- Acronym / sponsor ID
- INFRA / 2019/09-ERA-GHMG
- Conditions
- Disabilities Physical, Disabilities Mental
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Groupe Hospitalier Mutualiste de GrenobleUniversity, hospital or other
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 5 Aug 2021 (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.
France currently has more than 10 million disabled people, including 3 millions who could be better treated. In fact, people with disabilities face many obstacles in accessing care and receiving appropriate support (physical access to certain locations, communication...). Difficulties are also encountered by the healthcare staff, leading to often heterogeneous practices in health establishments.
The INFRA health circuit has been set up at the "Groupe Hospitalier Mutualiste de Grenoble" since June 2018 according to the guidelines published by the French High Authority for Health (HAS) on improving professional practices "Reception, support and organization of care in health establishments for people in situation of handicap "of July 2017. The INFRA nurse collects and anticipates the necessary adaptations for the patient's stay, in conjunction with their caregivers (whether family or institutional). They are an interface with other healthcare professionals to adapt care procedures and protocols (body care, feeding methods, pain management, drug management) to the patient's disability. Before hospitalization and until the patient is discharged, the INFRA nurse transmits to the personnel involved all the information necessary for the proper continuation of care. In addition to legal and regulatory obligations, the INFRA nurse ensures the effective accessibility of the establishment's facilities and premises, and helps maintaining patient autonomy.
The INFRA study is an observational study aimed at assessing the feasibility of the INFRA health circuit and evaluating the benefit for the patients and the healthcare staff.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with physical or mental disability, planned for surgical procedure and requiring an adaptation of their healthcare circuit
Key inclusion criteria (4 listed)
- 13 years old or more
- Physical or mental disability, according to french law n°2005-102 of February 11th, 2005
- Requiring an adaptation of the healthcare circuit
- Indication of a planned surgical procedure
Key exclusion criteria (2 listed)
- Outpatient
- Emergency surgery
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
Number of patients who followed the entirety of INFRA circuit
Time frame: At discharge, assessed up to 4 weeks
4 secondary outcomes
Type of pain evaluation scale selected by the INFRA nurse
Time frame: enrollment
Number of healthcare adaptations implemented during hospitalization
Time frame: At discharge, assessed up to 4 weeks
Satisfaction of patients and caregivers
Time frame: At discharge, assessed up to 4 weeks
Satisfaction of healthcare staff
Time frame: At discharge, assessed up to 4 weeks
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 7 Mar 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Disabilities Physical and Disabilities Mental, run by Groupe Hospitalier Mutualiste de Grenoble 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 4 inclusion and 2 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 7 Mar 2023. 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?
Number of patients who followed the entirety of INFRA circuit (time frame: At discharge, assessed up to 4 weeks). 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 7 Mar 2023.