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

NCT02894437 | Completed

• 1 other identifier: RC15_0023
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Pressure Ulcers

Keywords

prevention; organization; pressure ulcers

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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.

Other: qualitative interviews

Interventions

qualitative interviews OTHER

semi-structured interviews as a conceptual frame work

health professionals; patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, Loire Atlantique, 44093, France

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Pressure Ulcer

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Marc LE FORT, Dr

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: September 9, 2016
• Study Start: November 1, 2015
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: November 22, 2022

Record last verified: 2022-11

Locations

FR (1)