Clinical trial NCT02894437: Qualitative Study of Preventive Organization of the Pelvic Bedsores Injured Spinal Cord
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injuries
Pressure Ulcers
Keywords: prevention
organization
pressure ulcers
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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)

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.


Eligibility criteria: 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

Primary outcomes:
measure: Validation of a comprehensive conceptual framework reflecting the perceptions and behaviors of patients and professionals involved in the organization of care
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
state: Loire Atlantique
Study officials:
affiliation: Nantes University Hospital
name: Marc LE FORT, Dr
role: PRINCIPAL_INVESTIGATOR
References: