Clinical trial NCT03865173: Post-stroke Pathway: Analysis and Link With One Year Sequelae in a French Cohort of Stroke Patients
Official title: Post-stroke Pathway: Analysis and Link With One Year Sequelae in a French Cohort of Stroke Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Stroke Sequelae
Keywords: Stroke
Pathways
Sequelae
Health services research
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2019-03-06
Enrollment: 1138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with a confirmed ischemic or hemorrhagic stroke included in the Aquitaine Observatory of Stroke (ObA2) cohort and managed in the 13 participants centers and voluntary to participate

Brief summary: The link between post-stroke pathways and patient sequelae have not yet been clearly defined. The main purpose is to identify the post-stroke life pathways components associated with sequalae at 3 months and 1 year after the acute stroke episode.

Detailed description: Stroke is a serious health event, involving the entire health care system and generating considerable socioeconomic weight for society. Knowledge of the components, the diversity and the scalability of post-stroke life pathways is currently not sufficient. Moreover the link between post-stroke pathways and patient sequelae have not yet been clearly defined.

The main purpose is to identify the post-stroke life pathways components associated with sequalae at 3 months and 1 year after the acute stroke episode. The secondary objectives are: 1) To define a typology of the life pathways of stroke patients, , 2) To analyze the social and geographical inequalities in the management of stroke, 4) To estimate the cost of the pathway elements of stroke management; 5) Measure the sequelae of stroke patients at three months and one year after the acute episode.

The design is a prospective multicenter cohort study with a follow up to 1 year after the acute episode, managed in several hospitals in the Aquitaine region (France).

Eligibility criteria: Inclusion Criteria:

* Patient being over 18 years of age living in metropolitan France;
* Patient with recent stroke (not before 2019) whose diagnosis confirmed by a neuro-vascular physician;
* Patient managed for stroke in one of the 13 participating hospitals of the Aquitaine region;
* Patient giving consent to participate to PAPASéPA;
* Patient to be alive at the end of the acute management hospital stay

Exclusion Criteria:

* Patient refuse to participate to PAPASéPA
* Patient died during the initial stay

Primary outcomes:
measure: Modified Rankin Scale (mRS) Score
timeFrame: 3 months
measure: Modified Rankin Scale (mRS) Score
timeFrame: 1 year
Secondary outcomes:
measure: Telephone Interview for Cognitive Status Modified (TICS) Score
timeFrame: 3 months
measure: Telephone Interview for Cognitive Status Modified (TICS) Score
timeFrame: 1 year
measure: Hospital anxiety and depression scale (HADS) Score
timeFrame: 3 months
measure: Hospital anxiety and depression scale (HADS) Score
timeFrame: 1 year
measure: Fatigue Severity Scale (FSS) Score
timeFrame: 3 months
measure: Fatigue Severity Scale (FSS) Score
timeFrame: 1 year
measure: Barthel Index (BI) Score
timeFrame: 3 months
measure: Barthel Index (BI) Score
timeFrame: 1 year
measure: Community Integration Questionnaire (CIQ-R) Score
timeFrame: 3 months
measure: Community Integration Questionnaire (CIQ-R) Score
timeFrame: 1 year
Other outcomes:
Locations:
city: Agen
country: France
facility: CH Agen
city: Blaye
country: France
facility: CH Blaye
city: Bordeaux
country: France
facility: CHU Bordeaux
city: La Teste de Buch
country: France
facility: CH Arcachon
city: Langon
country: France
facility: CH Sud Gironde - Langon
city: Lesparre-Médoc
country: France
facility: Clinique Mutualiste Lesparre Médoc
city: Libourne
country: France
facility: CH Libourne
city: Marmande
country: France
facility: CHIC Marmande-Tonneins
city: Mont de Marsan
country: France
facility: CH Mont de Marsan - site Layné
city: Oloron-Sainte-Marie
country: France
facility: CH Oloron
city: Orthez
country: France
facility: CH Orthez
city: Pau
country: France
facility: CH Pau
city: Villeneuve sur Lot
country: France
facility: Pôle de Santé du Villeneuvois
Study officials:
References:
citation: Broussy S, Rouanet F, Lesaine E, Domecq S, Kret M, Maugeais M, Aly F, Dehail P, Benard A, Wittwer J, Salamon R, Sibon I, Saillour-Glenisson F. Post-stroke pathway analysis and link with one year sequelae in a French cohort of stroke patients: the PAPASePA protocol study. BMC Health Serv Res. 2019 Oct 29;19(1):770. doi: 10.1186/s12913-019-4522-2.