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Clinical Trials/NCT02855970
NCT02855970CompletedNot Applicable

Development and Validation of a French Quality Of Life Scale Specific to Patients Who Have Suffered a Stroke

Centre Hospitalier Universitaire Dijon2 sites in 1 country61 target enrollmentStarted: February 16, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
61
Locations
2
Primary Endpoint
responses to a quality of life questionnaire

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Arms & Interventions

patient

Experimental

Intervention: completion of a quality of life questionnaire (Other)

Outcomes

Primary Outcomes

responses to a quality of life questionnaire

Time Frame: Change compared with baseline score at Day 15, Day 60

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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