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

NCT ID: NCT02855970

Last Updated: 2019-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-16

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.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

patient

Group Type: EXPERIMENTAL

completion of a quality of life questionnaire

Intervention Type: OTHER

Interventions

completion of a quality of life questionnaire

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Universitaire

Dijon, , France

Countries

France

Other Identifiers

Béjot 2014

Identifier Type: -

Identifier Source: org_study_id