Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Quality of Life in Neuromuscular Disease (QoLNMD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02895763
Recruitment Status : Completed
First Posted : September 12, 2016
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Brief Summary:
A Quality work was conducted to enable the future construction of a Quality of Life Questionnaire Related to Health (HRQoL) in patients with slowly progressive neuromuscular disease (NMD) as myopathies and muscular dystrophies. The discussion group training is an effective method to perform a thorough investigation of aspects of HRQoL potentially altered by NMD. Patients were recruited in France by 4 reference centers MNMs. All verbal interactions between participants focus groups were recorded. A qualitative analysis of the transcript was performed. The transcript provided 2424 CIF categories. The results helped to identify and quantify aspects of life that are altered by NMDs between patients. A pool of 64 items and a validated questionnaire (the WHOQOLBREF) were thern passed by 159 patients enrolled in eight reference centers MNMs. The investigators constructed a questionnaire called QoLNMD which is composed of two general items and 24 items classified into three areas: (1) \ Impact bodily symptoms, "(2) \ Self-perception" and (3) \ Activity participation. "Each area has good psychometric properties (Cronbach's alpha> 0.77, test-retest ICC> 0.81, H Loevinger> 0.41) and met the assumptions of IRT. the comparison with the WHOQOL-BREF was used to assess similarities and differences with a generic questionnaire. The next step was to validate the QoLNMD reassessing its psychometric properties in a new patient sample and calibrate the IRT measurement system. The purpose of these new part of study was to validate the French version of the QoL-NMD on a confirmatory sample of patients and to calibrate its measurement system. A prospective study in 8 NMD referral centers (France) was conducted. Both the QoL-NMD and a validated generic questionnaire (the WHOQOLBREF) were administered to patients. 156 patients were included for the confirmatory psychometric analysis. All three domains showed adequate psychometric properties and met IRT assumptions. The IRT model calibration was then performed successfully on 315 patients. The French version of the QoL-NMD showed adequate psychometric properties and can be used in rehabilitation services. A conversion table enables easy transformation of sum scores into IRT-calibrated measures. Minimum detectable change tables help interpreting score change.

Condition or disease Intervention/treatment
Quality of Life Muscular Dystrophies Other: Form administrations

  Show Detailed Description

Layout table for study information
Study Type : Observational
Actual Enrollment : 159 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of a New Scale of Quality of Life, Specific of Neuro Muscular Diseases and More Specifically of Steinert Disease, by the Rasch Model Methods.
Study Start Date : June 2006
Actual Primary Completion Date : December 2012
Actual Study Completion Date : June 2013


Group/Cohort Intervention/treatment
Neuro Muscular disease patients
French Patients, young adults and adults, with a diagnosed neuromuscular disease, of any known form.
Other: Form administrations



Primary Outcome Measures :
  1. Self reported form of items measuring the Quality of Life [ Time Frame: 0 month ]
    The Quality of Life questionnaire used is QoLNMD


Secondary Outcome Measures :
  1. Self reported form of items measuring the Quality of Life [ Time Frame: 6 months ]
    The Quality of Life questionnaire used is QoLNMD

  2. Self reported form of items measuring the Quality of Life [ Time Frame: 1 year ]
    The Quality of Life questionnaire used is QoLNMD



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
French Patients, young adults and adults, with a diagnosed neuromuscular disease, of any known form.
Criteria

Inclusion Criteria:

  • Patient with neuromuscular disease

Exclusion Criteria:

  • <18 yo

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02895763


Locations
Layout table for location information
France
Chu de Reims
Reims, France, 51092
Sponsors and Collaborators
CHU de Reims

Layout table for additonal information
Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT02895763     History of Changes
Other Study ID Numbers: 2015Ao005
First Posted: September 12, 2016    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016

Keywords provided by CHU de Reims:
QUALITY OF LIFE
NEUROMUSCULAR DISEASES

Additional relevant MeSH terms:
Layout table for MeSH terms
Muscular Dystrophies
Neuromuscular Diseases
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Genetic Diseases, Inborn