Qualitative Study of Preventive Organization of the Pelvic Bedsores Injured Spinal Cord

Spinal Cord Injuries Clinical Trial

— QUALIPREPS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02894437
• Other study ID #: RC15_0023
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Pressure Ulcer
• Pressure Ulcers
• Spinal Cord Injuries

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