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

Sponsor

Nantes University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT02894437

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injuries Pressure Ulcers	Other: qualitative interviews

Study Design

Study Type:

Observational

Anticipated Enrollment :

45 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

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 Start Date :

Nov 1, 2015

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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 semi-structured interviews as a conceptual frame work
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 semi-structured interviews as a conceptual frame work

Arm

Intervention/Treatment

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

semi-structured interviews as a conceptual frame work

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

semi-structured interviews as a conceptual frame work

Outcome Measures

Primary Outcome Measures

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 .

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nantes University Hospital	Nantes	Loire Atlantique	France	44093

Sponsors and Collaborators

Nantes University Hospital

Investigators

Principal Investigator: Marc LE FORT, Dr, Nantes University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nantes University Hospital

ClinicalTrials.gov Identifier:

NCT02894437

Other Study ID Numbers:

RC15_0023

First Posted:

Sep 9, 2016

Last Update Posted:

Dec 28, 2021

Last Verified:

Dec 1, 2021

Keywords provided by Nantes University Hospital

prevention

organization

pressure ulcers

Additional relevant MeSH terms:

Spinal Cord Injuries

Pressure Ulcer

Study Results

No Results Posted as of Dec 28, 2021