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

Completed

• Conditions: Spinal Cord Injuries; Pressure Ulcers
• Interventions: Other: qualitative interviews

• Registration Number: NCT02894437
• Lead Sponsor: Nantes University Hospital

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-08-11
• Study First Submitted QC: 2016-09-08
• Study First Posted: 2016-09-09
• Primary Completion: 2022-09
• Study Completion: 2022-09
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-21
• Last Update Posted: 2022-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients	qualitative interviews	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
health professionals	qualitative interviews	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.

Primary Outcome Measures

Name	Time	Method
Validation of a comprehensive conceptual framework reflecting the perceptions and behaviors of patients and professionals involved in the organization of care	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 .

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, Loire Atlantique, France