Impact of Multiple Sclerosis From the Viewpoint of the Patients and Their Caregivers

NCT02388334 | Completed DMC

• 1 other identifier: PREPS 13-0227
• Study Type: observational
• Target: 1,080
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with chronic illness and their relatives have exhaustive and specific experience of healthcare and the health service.These unique experiences must be taken into account for quality of care management assessment. MS affects young patients whose illness and level of disability will worsen throughout their lives. Half the patients living with MS require a natural (non professional) caregiver's support and this level of investment increases with the degree of disability. No dedicated tools for patients living with MS and their caregivers are currently available to assess their experience of the quality of care management.

Conditions

Multiple Sclerosis

Keywords

patients experience; caregivers experience; quality of care; quality of life

Outcome Measures

Primary Outcomes (1)

• Validation phase of the questionnaire

  The validation phase of V2 comprises the analysis of the construct's reliability, exploratory and confirmatory stages of tool structuration in dimensions, and the reproducibility of the findings generated. It relies on the recruitment of caregivers who did not participate in the preceding steps. To verify the stability of tool responses, another test round by 20% of the responders will be conducted 15 +/- 5 days after the first evaluation. Finally, an analysis of sensitivity to change (e.g. initiation of a new treatment, transition to a progressive form; changes in disease management; changes in caregiver's situation) will be conducted.

  2 years

Interventions

to develop standardized questionnaires OTHER

The aim of our project is to develop, from the patients living with MS and their natural caregivers' point of view, standardized questionnaires evaluating their experience concerning the global quality of care management, in accordance with psychometric standards. The questionnaires will be developed in two phases : item generation (Phase 1) and validation (Phase 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients living with MS and their natural caregivers

You may qualify if:

• For the patients the criteria were :
• to be 1) aged 18 years or older, 2) diagnosed with any form of definitivee MS according to the McDonald criteria, excluding clinically isolated syndrome, and 3) fluent in the French language.
• For their caregivers, the criteria were to be 1) aged 18 years or older, 2) designated by the patient as a natural caregiver (i.e. noninstitutional relative/person most closely involved in the decisions linked to the disease), 3) fluent in the French language, and 4) free from MS. All patients and caregivers gave their written informed consent.

You may not qualify if:

• Caregivers and patients incapable of understanding the proposed procedure and the questionnaire

Sponsors & Collaborators

• Rennes University Hospital: lead
• Ministry of Health, France: collaborator
• University Hospital, Clermont-Ferrand: collaborator
• Nantes University Hospital: collaborator
• University Hospital, Angers: collaborator
• Central Hospital, Nancy, France: collaborator
• University Hospital, Strasbourg: collaborator
• University Hospital, Marseille: collaborator

Study Sites (1)

Rennes University Hospital

Rennes, 35033, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• David Veillard

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: March 17, 2015
• Study Start: January 15, 2015
• Primary Completion: June 13, 2023
• Study Completion: June 13, 2023
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

FR (1)