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

March 13, 2015 updated by: Rennes University Hospital

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

730

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Natural caregivers of Multiple Sclerosis patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

March 9, 2015

First Submitted That Met QC Criteria

March 13, 2015

First Posted (Estimate)

March 17, 2015

Study Record Updates

Last Update Posted (Estimate)

March 17, 2015

Last Update Submitted That Met QC Criteria

March 13, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREPS 13-0227

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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