Impact of Multiple Sclerosis From the Viewpoint of the Patients and Their Caregivers (AQUASEP)

Impact of Multiple Sclerosis From the Viewpoint of the Patients and Their Natural Caregivers : Exploring Their Expectations Concerning the Quality of Carel Management and Their Quality Of Life

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: to develop standardized questionnaires

Detailed Description

Although consideration of the patients' point of view to evaluate the effectiveness and quality of therapeutic strategies and, more widely, heathcare interventions have been imposed for the last 20 years in our healthcare systems, the data on caregivers' viewpoints are more recent. Authors concurred that assessing patients and caregivers'needs and experiences is a more appropriate source of information to identify their expectations concerning the quality of the healthcare system rather than the concept of "patient satisfaction". Their expectations regarding the global quality of care management is not documented in France, notably because of the lack of adapted tools.

The original tools validated will complete the palette of those that we are developing (quality indicators) to evaluate the quality of care of MS patients according to different dedicated organizations (formal networks or not, focused on the patients or professionals).

• Study Type: Observational
• Enrollment (Actual): 1080

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35033
    • Rennes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients living with MS and their natural caregivers

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Collaborators: University Hospital, Angers; Ministry of Health, France; Central Hospital, Nancy, France; University Hospital, Clermont-Ferrand; Nantes University Hospital; University Hospital, Marseille; University Hospital, Strasbourg
• Investigators: Principal Investigator: David Veillard, Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2015
• Primary Completion (Actual): June 13, 2023
• Study Completion (Actual): June 13, 2023

Study Registration Dates

• First Submitted: March 9, 2015
• First Submitted That Met QC Criteria: March 13, 2015
• First Posted (Estimated): March 17, 2015

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: quality of life; quality of care; patients experience; caregivers experience
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis
• Other Study ID Numbers: PREPS 13-0227