Spinal Cord InjuriesQUALIPREPSNCT02894437
Qualitative Study of Preventive Organization of the Pelvic Bedsores Injured Spinal Cord
An observational study of Spinal Cord Injuries and Pressure Ulcers, run by Nantes University Hospital at 1 site in France.
Trial summary
The purpose of the Protocol is the prevention of pelvic pressure ulcers within a care network of SCI patients whose general organization refers to the medical literature and the recommendations of the ministerial circular of 18 June 2004. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Pressure Ulcers
- What is being tested?
- qualitative interviews
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2015to 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of SCI patients recruited in the Physical Medicine and Nantes University Hospital Rehabilitation 15 to 30 patients will be included. Meanwhile, from 10 to 15 professionals involved in the care sector with SCI Nantes University Hospital (mainly caregivers and administrative staff)
Who may be able to join
- - Paying patients:
- Spinal cord injured person from any level of injury and any post-traumatic period
- Age 18 to 65 years inclusive
- Person affiliated to the social security or receiving such a plan
- Main ambulation mode: Wheelchair
- Agreeing to participate in interviews
Show all 9Show fewer
- -- Professional side:
- Medical and paramedical health professionals involved in the care sector or studied various professionals (administrators, insurers, ...) involved in the studied care sector
- Agreeing to participate in interviews
Who cannot join
- Minors or patients older than 65 years
- Person unable to consent
- Who do not speak the French language
- Person refusing to attend meetings
- Hospitalized person without consent
- Cognitive pathologies incompatible with interviews
- Main wandering mode of patients: walking
- Protected adults
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Qualitative Study of Preventive Organization of the Pelvic Bedsores Injured Spinal Cord: Building a Conceptual Framework Based on the Perceptions and Behaviors of Patients and Professionals Involved
The purpose of the Protocol is the prevention of pelvic pressure ulcers within a care network of SCI patients whose general organization refers to the medical literature and the recommendations of the ministerial circular of 18 June 2004. A conceptual framework for work (CFW) will be set up and semi-structured interviews will be conducted with patients and professionals. They will confirm or dismiss the CFW gradually with a refined coding As of domains and sub-domains of the skin preventing spinal cord injury related to the perceptions and behaviors of those involved in the sector. Quality control will be provided by experts in qualitative research and interviews will be stopped when the analyzes will further refine the domains and subdomains. A final framework will be validated to modulate our organization.
- Conditions
- Spinal Cord Injuries, Pressure Ulcers
- Being tested
- qualitative interviews
- Keywords
- prevention, organization, pressure ulcers
- Medical subject headings
- Spinal Cord Injuries, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
qualitative interviewsOther
semi-structured interviews as a conceptual frame work
| Study group | Role | What they receive |
|---|---|---|
| patients | SCI recruited Physical Medicine and Nantes University Hospital Rehabilitation. Recruitment will try to balance the number of people in four sub-groups followed and complicated (= history of pelvic pressure sores), not followed and uncomplicated, monitored and uncomplicated, not followed and complicated Receives: Other: qualitative interviews | |
| health professionals | those involved in the chain of care Spinal Cord concerning various professions (including medical, paramedical and administrative) decision and variable influence on the organization of the die care of spinal injuries. Receives: Other: qualitative interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of a comprehensive conceptual framework reflecting the perceptions and behaviors of patients and professionals involved in the organization of care
specific conceptual framework of preventive organization of the eschar with SCI from domains and subdomains reflecting the perceptions and behaviors of patients and professionals applicable to organizational changes in the medical care of spinal cord injury .
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startNov 2015
- Primary completionSep 2022
- Study completionSep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc LE FORT, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894437
- Sponsor's protocol ID
- RC15_0023
- Acronym
- QUALIPREPS
- Status last verified
- Nov 2022
- First submitted
- 11 Aug 2016
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Study of Preventive Organization of the Pelvic Bedsores Injured Spinal Cord: Building a Conceptual Framework Based on the Perceptions and Behaviors of Patients and Professionals Involved
- ClinicalTrials.gov ID
- NCT02894437
- Acronym / sponsor ID
- QUALIPREPS / RC15_0023
- Conditions
- Spinal Cord Injuries, Pressure Ulcers
- Keywords
- prevention, organization, pressure ulcers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Sep 2022 (actual)
- Study completion
- Sep 2022 (actual)
- First posted
- 9 Sep 2016 (estimated)
- 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.
The purpose of the Protocol is the prevention of pelvic pressure ulcers within a care network of SCI patients whose general organization refers to the medical literature and the recommendations of the ministerial circular of 18 June 2004. A conceptual framework for work (CFW) will be set up and semi-structured interviews will be conducted with patients and professionals. They will confirm or dismiss the CFW gradually with a refined coding As of domains and sub-domains of the skin preventing spinal cord injury related to the perceptions and behaviors of those involved in the sector. Quality control will be provided by experts in qualitative research and interviews will be stopped when the analyzes will further refine the domains and subdomains. A final framework will be validated to modulate our organization.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients | – | Other: qualitative interviewsSCI recruited Physical Medicine and Nantes University Hospital Rehabilitation. Recruitment will try to balance the number of people in four sub-groups followed and complicated (= history of pelvic pressure sores), not followed and uncomplicated, monitored and uncomplicated, not followed and complicated |
| health professionals | – | Other: qualitative interviewsthose involved in the chain of care Spinal Cord concerning various professions (including medical, paramedical and administrative) decision and variable influence on the organization of the die care of spinal injuries. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of SCI patients recruited in the Physical Medicine and Nantes University Hospital Rehabilitation 15 to 30 patients will be included. Meanwhile, from 10 to 15 professionals involved in the care sector with SCI Nantes University Hospital (mainly caregivers and administrative staff)
Key inclusion criteria (9 listed)
- - Paying patients:
- Spinal cord injured person from any level of injury and any post-traumatic period
- Age 18 to 65 years inclusive
- Person affiliated to the social security or receiving such a plan
- Main ambulation mode: Wheelchair
Key exclusion criteria (8 listed)
- Minors or patients older than 65 years
- Person unable to consent
- Who do not speak the French language
- Person refusing to attend meetings
- Hospitalized person without consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| qualitative interviewssemi-structured interviews as a conceptual frame work | Other | health professionals, patients |
Primary outcome
Validation of a comprehensive conceptual framework reflecting the perceptions and behaviors of patients and professionals involved in the organization of care
Time frame: Baseline
specific conceptual framework of preventive organization of the eschar with SCI from domains and subdomains reflecting the perceptions and behaviors of patients and professionals applicable to organizational changes in the medical care of spinal cord injury .
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 22 Nov 2022.
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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.
Marc LE FORT, Dr principal investigator
Nantes University Hospital
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 Spinal Cord Injuries and Pressure Ulcers, run by Nantes University Hospital 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 9 inclusion and 8 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 22 Nov 2022. 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?
Validation of a comprehensive conceptual framework reflecting the perceptions and behaviors of patients and professionals involved in the organization of care (time frame: Baseline). 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 22 Nov 2022.