Validation of a French Quality of Life Questionnaire Adapted to Persons Who Have Suffered a Stroke
QUALI STROKE
Development and Validation of a French Quality Of Life Scale Specific to Patients Who Have Suffered a Stroke
1 other identifier
interventional
61
1 country
1
Brief Summary
The aim of this work is to develop and validate a scale adapted to French cultural characteristics. It will be based on the SS-QoL scale and be simple and quick to use in everyday practice. It is not simply a translation. This transcultural adaptation requires linguistic and psychometric validation, by studying its validity, its reliability and its sensitivity to change, as though it were a new instrument. The investigators will then develop a short version by reducing the items and conduct a psychometric validation. The translation and validation of a short French version of the SS-QoL scale will generate a reliable and sensitive, easy-to-use tool suitable for use in everyday practice. The final objective is to use this tool as a principal judgement criterion in future therapeutic trials and in patients of the Dijon Stroke Registry to bring to light prognostic factors that affect quality of life so as to provide better management of this disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2015
CompletedFirst Submitted
Initial submission to the registry
August 2, 2016
CompletedFirst Posted
Study publicly available on registry
August 4, 2016
CompletedMay 3, 2019
May 1, 2019
7 months
August 2, 2016
May 2, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
responses to a quality of life questionnaire
Change compared with baseline score at Day 15, Day 60
Study Arms (1)
patient
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patients aged 18 years and older.
- Patients following a first stroke (ischemic or non-traumatic cerebral parenchyma haemorrhage) followed at a consultation at Dijon CHU and included in the Dijon Stroke Registry cohort.
- Patients who have provided oral informed consent.
- Patients with national health insurance cover
You may not qualify if:
- History of symptomatic stroke.
- Meningeal haemorrhage.
- Severe visual or hearing handicap making it difficult to complete the questionnaire.
- Global severe aphasia and mutism making communication with the patient impossible-.
- Unable to read or speak French.
- Dementia prior to the stroke.
- Psychiatric disorders and dependence on alcohol/drugs.
- Bedridden before the stroke.
- Other comorbidities considered severe by the clinician and not related to the stroke that could have significantly impaired quality of life before the stroke.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Universitaire
Dijon, 21079, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2016
First Posted
August 4, 2016
Study Start
February 16, 2015
Primary Completion
August 31, 2015
Last Updated
May 3, 2019
Record last verified: 2019-05