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Completed

NCT Number: NCT02855970

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

completion of a quality of life questionnaire

Other

Primary outcomes

  1. responses to a quality of life questionnaire

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

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

Acronym: QUALI STROKE

Important dates

Study start
2015
Primary completion
2015
First posted
Aug 4, 2016
Registry last updated
May 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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