ClinicalTrials.Veeva

Menu

Impact of Multiple Sclerosis From the Viewpoint of the Caregivers (AQUASEP)

R

Rennes University Hospital

Status

Unknown

Conditions

Multiple Sclerosis

Treatments

Other: to develop a standardized questionnaire

Study type

Observational

Funder types

Other

Identifiers

NCT02388334
PREPS 13-0227

Details and patient eligibility

About

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).

Full 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.

Enrollment

730 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

0

Loading...

Central trial contact

David Veillard; Yoann Desille

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems