Multiple SclerosisAQUASEPNCT02388334
Impact of Multiple Sclerosis From the Viewpoint of the Patients and Their Caregivers
An observational study of Multiple Sclerosis, run by Rennes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- to develop standardized questionnaires
- How many people
- 1,080 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2015to 13 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients living with MS and their natural caregivers
Who may be able to join
- 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.
Who cannot join
- Caregivers and patients incapable of understanding the proposed procedure and the questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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).
- Conditions
- Multiple Sclerosis
- Being tested
- to develop standardized questionnaires
- Keywords
- patients experience, caregivers experience, quality of care, quality of life
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
to develop standardized questionnairesOther
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study start15 Jan 2015
- Primary completion13 Jun 2023
- Study completion13 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,080 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France, Nantes University Hospital, University Hospital, Angers, Central Hospital, Nancy, France, University Hospital, Strasbourg, University Hospital, Marseille, University Hospital, Clermont-Ferrand
- Responsible party
- Sponsor
- Investigators
- David Veillard, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388334
- Sponsor's protocol ID
- PREPS 13-0227
- Acronym
- AQUASEP
- Status last verified
- Jun 2026
- First submitted
- 9 Mar 2015
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02388334
- Acronym / sponsor ID
- AQUASEP / PREPS 13-0227
- Conditions
- Multiple Sclerosis
- Keywords
- patients experience, caregivers experience, quality of care, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,080 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, France, Nantes University Hospital, University Hospital, Angers, Central Hospital, Nancy, France, University Hospital, Strasbourg, University Hospital, Marseille, University Hospital, Clermont-Ferrand
- Study start
- 15 Jan 2015 (actual)
- Primary completion
- 13 Jun 2023 (actual)
- Study completion
- 13 Jun 2023 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients living with MS and their natural caregivers
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Caregivers and patients incapable of understanding the proposed procedure and the questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| to develop standardized questionnairesThe 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) | Other | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Veillard principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation phase of the questionnaire (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.