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

Sponsor

Centre Hospitalier Universitaire Dijon (Other)

Overall Status

Completed

CT.gov ID

NCT02855970

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Other: completion of a quality of life questionnaire	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

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

Actual Study Start Date :

Feb 16, 2015

Actual Primary Completion Date :

Aug 31, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: patient	Other: completion of a quality of life questionnaire

Arm

Intervention/Treatment

Experimental: patient

Other: completion of a quality of life questionnaire

Outcome Measures

Primary Outcome Measures

responses to a quality of life questionnaire [Change compared with baseline score at Day 15, Day 60]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire	Dijon		France	21079

Sponsors and Collaborators

Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire Dijon

ClinicalTrials.gov Identifier:

NCT02855970

Other Study ID Numbers:

Béjot 2014

First Posted:

Aug 4, 2016

Last Update Posted:

May 3, 2019

Last Verified:

May 1, 2019

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of May 3, 2019