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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02894437
Other study ID # RC15_0023
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2015
Est. completion date September 2022

Study information

Verified date November 2022
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date September 2022
Est. primary completion date September 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - - 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 -- 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
qualitative interviews
semi-structured interviews as a conceptual frame work

Locations

Country Name City State
France Nantes University Hospital Nantes Loire Atlantique

Sponsors (1)

Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 . Baseline
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