- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02971774
Development of a Multimodal Approach to Assess Stroke Patients Daily Life Activities
Development of a Multimodal Approach to Assess Stroke Persons Daily Life Activities and Development of a New Tool to Evaluate the Impact of Functional Activites on Quality of Life
Panoramica dello studio
Stato
Descrizione dettagliata
- To conduct the research, a sociologist will collaborate with Doctor Nicolas Roche, the study director. The contribution of a sociologist will offer a viewpoint from outside the medical aspect, which will allow more global identification of the areas of the lives of patients that are affected by hemiparesis. Furthermore, the sociological perspective will seek to demonstrate the social aspects, which have heretofore been explored little or not at all in medical and public health studies, such as, for example, in terms of intimacy or self-image. It must delicately capture the practices, logic of action and though of the patients, by placing them in the social contexts in which they evolve and develop. Therefore, attention will be paid to certain "social determinants" (such as sociocultural setting, age or gender) and certain resources (particularly economic, relational and material), which can have an effect on the ways in which patients perceive and cope with the consequences of their hemiparesis. The role of loved ones (partner, family members, friends) will also be examined, since many sociological works have shown that they are usually on the front line to accompany, shape and manage the effects of the motor impairment.
- The study will target adults regularly followed in the department of physical medicine and rehabilitation of the Raymond-Poincaré hospital. These individuals must present with hemiparesis secondary to a single, hemispheric cerebrovascular accident, be living at home and be able to move inside and outside of the home.
Patients having several severe cognitive disorders or aphasia will not be interviewed.
The study will include an exploration phase (a corpus of approximatively 30 examinations) and a quantitative component (approximatively 100 questionnaires).
Once the examinations have been completed, the preparation of the questionnaire will be done with the validation of clinical experts. The questionnaire will include approximately 20 items, distributed over several dimensions of patients' lives. The participants' response time to the questionnaire should be in a range from 8 to 12 minutes, in order to facilitate its insertion in the professional practices when the patients are at a hospital visit.
The researcher will be in charge of completion of the questionnaire. This will be performed around or during the consultation of patients at Raymond-Poincaré hospital. The first completions will be recorded (with the written approval of surveyed patients) in order to be able to work on possible improvements, particularly in terms of the order of questions or in their understanding and response options. After ten completions, the questionnaire will be slightly revised if modifications appear necessary, then will remain the same until the desired volume of questionnaires is received (approximatively 100).
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Garches, Francia, 92380
- Reclutamento
- Raymond Poincaré Hospital
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Contatto:
- Nicolas Roche, MD PhD
- Numero di telefono: 0033147105409
- Email: roche.nicolas@aphp.fr
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Patient older than 18 years old
- patient with hemiparesis secondary to a single hemispheric cerebrovascular accident
- be living at home
- be able to move inside and outside of the home
Exclusion Criteria:
- Patients having several severe cognitive disorders
- Patients having severe aphasia
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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questionnary
self administered questionnary
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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daily life questionnary
Lasso di tempo: 45 minutes
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45 minutes
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Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2005997
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .