ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02855970
Recruitment Status : Completed
First Posted : August 4, 2016
Last Update Posted : August 4, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
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
Study Start Date : February 2015
Actual Primary Completion Date : August 2015

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



Primary Outcome Measures :
  1. responses to a quality of life questionnaire [ Time Frame: Change compared with baseline score at Day 15, Day 60 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02855970


Locations
France
Centre Hospitalier Universitaire
Dijon, France, 21079
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02855970     History of Changes
Other Study ID Numbers: Béjot 2014
First Posted: August 4, 2016    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases