Impact of Multiple Sclerosis From the Viewpoint of the Caregivers

NCT02388334 | Unknown DMC

• 1 other identifier: PREPS 13-0227
• Study Type: observational
• Target: 730
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Multiple Sclerosis

Keywords

Caregivers; Quality of life; Quality of care

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Interventions

to develop a standardized questionnaire OTHER

to develop, from the caregivers' point of view, a standardized questionnaire evaluating 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 development of this standardized tool will also : * identify the specific support needs of the caregivers * study the links between the quality of care as perceived by the professionals, patients and caregivers * identify the characteristics of the caregivers (status) and patients (disease type, disease-modifying drug (DMD) initiation, disease duration) associated with questionnaire results.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Natural caregivers of Multiple Sclerosis patients

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Rennes University Hospital: lead
• Ministry of Health, France: collaborator
• Nantes University Hospital: collaborator
• University Hospital, Angers: collaborator
• Central Hospital, Nancy, France: collaborator
• University Hospital, Strasbourg: collaborator
• University Hospital, Marseille: collaborator
• University Hospital, Clermont-Ferrand: collaborator

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• David Veillard

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Veillard

CONTACT

+33299289776; david.veillard@chu-rennes.fr

Yoann Desille

CONTACT

+33299289220; yoann.desille@chu-rennes.fr

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: March 17, 2015
• Study Start: March 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2017
• Last Updated: March 17, 2015

Record last verified: 2015-03