Clinical trial NCT02388334: Impact of Multiple Sclerosis From the Viewpoint of the Caregivers
Official title: Impact of Multiple Sclerosis From the Viewpoint of the Caregivers : Exploring Their Quality Of Life and Their Expectations Concerning the Quality of Professional Management
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Keywords: Caregivers
Quality of life
Quality of care
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
name: Nantes University Hospital
name: University Hospital, Angers
name: Central Hospital, Nancy, France
name: University Hospital, Strasbourg
name: University Hospital, Marseille
name: University Hospital, Clermont-Ferrand
First posted: 2015-03-17
Enrollment: 730
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Natural caregivers of Multiple Sclerosis patients

Brief summary: Half the MS patients require a natural (non professional) caregiver's support for daily living activities and this level of investment increases with the degree of disability.

The caregiver's role is an essential key factor in the "therapeutic alliance" between the patient and heath professionals. The impact on the natural caregivers' Quality Of Life (QOL) and their expectations for the global quality of management are not documented, notably because of the lack of adapted tools.

The aim of the investigators' project is to develop, from the caregivers' point of view, a standardized questionnaire evaluating 1) their QOL as related to the disease of the assisted and 2) their expectations concerning the global quality of professional management (care, coordination, information...).

1) their quality of life (QOL) as related to the disease of the assisted and 2) their expectations concerning the global quality of professional management (care, coordination, information...).

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

Detailed description: Half the MS patients require a natural (non professional) caregiver's support for daily living activities and this level of investment increases with the degree of disability. Authors considered that an approach focused on the caregiver's burden limits the perception and evaluation of the real impact of his/her role at the patient's side, just as it probably limits the effectiveness of interventions used and the support they can be offered. According to them, the concept of QOL linked to the disease of the assisted person would be better adapted to respond to this question, because of its multidimensional approach, along with the potential secondary benefits of caregiving.

Although consideration of the patients' point of view to evaluate the effectiveness and quality of therapeutic strategies and, more widely, healthcare interventions have been imposed for the last 20 years in the investigators' healthcare systems, the data on caregivers' viewpoints are more recent. Authors concurred that assessing 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". The impact of MS on the natural caregivers' QOL and expectations for the global quality of management is not documented in France, notably because of the lack of adapted tools. So, if caregivers' support capacities are exceeded primarily because of their own impaired QOL and their expectations for the quality of management are not considered, the therapeutic contract will be diminished, thereby worsening the overall quality of management for MS patients.

The original tool validated will complete the palette of those that the investigators are developing to evaluate the quality of care of MS patients according to different dedicated organizations (formal networks or not, focused on the patients or professionals). All tools will initially be tested together, in the framework of the IRSEP project (funding by the ministry of health : PREQHOS n° 2010-A0096138) on 3 regional population-based cohorts.

Eligibility criteria: Inclusion Criteria:

* Age eligible for caregivers and patients : 18 years and over
* Patients with diagnosis of definite MS.
* In order to consider the diversity of the situations, socio-demographics (gender of the patient, status of the caregiver) and disease's evolution (disability status, time since first symptoms) characteristics will be considered for

Exclusion Criteria:

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

Primary outcomes:
measure: Validation phase of the questionnaire
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rennes University Hospital
name: David Veillard
role: PRINCIPAL_INVESTIGATOR
References: