Validation of a French Quality of Life Questionnaire Adapted to Persons Who Have Suffered a Stroke

Stroke Clinical Trial

— QUALI STROKE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02855970
• Other study ID #: Béjot 2014
• Status: Completed
• Phase: N/A
• Start date: February 16, 2015

Study information

• Verified date: May 2019
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. primary completion date: August 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• completion of a quality of life questionnaire

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	responses to a quality of life questionnaire		Change compared with baseline score at Day 15, Day 60