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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rennes University Hospital

Rennes, 35033, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

Validation phase of the questionnaire

Time frame: 2 years

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.

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Collaborators

Central Hospital, Nancy, France
Ministry of Health, France
Nantes University Hospital
University Hospital, Angers
University Hospital, Clermont-Ferrand
University Hospital, Marseille
University Hospital, Strasbourg

Registry information

Official study title

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

Acronym: AQUASEP

Important dates

Study start: 2015
Primary completion: 2023
Study completion: 2023
First posted: Mar 17, 2015
Registry last updated: Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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