Impact of Multiple Sclerosis From the Viewpoint of the Caregivers

Multiple Sclerosis Clinical Trial

— AQUASEP  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02388334
• Other study ID #: PREPS 13-0227
• Status: Not yet recruiting
• Phase: N/A
• First received: March 9, 2015
• Last updated: March 13, 2015
• Start date: March 2015
• Est. completion date: June 2017

Study information

• Verified date: March 2015
• Source: Rennes University Hospital
• Contact: David Veillard
• Phone: +33299289776
• Email: david.veillard[@]chu-rennes.fr
• Is FDA regulated: No
• Health authority: France: Ministère de l'Enseignement supérieur et de la Recherche
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 730
• Est. completion date: June 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• to develop a standardized questionnaire
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.

Locations

Country	Name	City	State
n/a

Sponsors (8)

Lead Sponsor	Collaborator
Rennes University Hospital	Central Hospital, Nancy, France, Ministry of Health, France, Nantes University Hospital, University Hospital, Angers, University Hospital, Clermont-Ferrand, University Hospital, Marseille, University Hospital, Strasbourg

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No