NCT03865173

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,138

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

Geographic Reach
1 country

13 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 6, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

November 18, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

3 years

First QC Date

February 22, 2019

Last Update Submit

March 29, 2022

Conditions

StrokeStroke Sequelae

Keywords

StrokePathwaysSequelaeHealth services research

Outcome Measures

Primary Outcomes (2)

  • Modified Rankin Scale (mRS) Score

    Activity limitations post-stroke measure. Minimum score : 0 "No symptoms at all " Maximum score : 6 "Dead"

    3 months

  • Modified Rankin Scale (mRS) Score

    Activity limitations post-stroke measure Minimum score : 0 "no symptom" Maximum score : 6 "death"

    1 year

Secondary Outcomes (10)

  • Telephone Interview for Cognitive Status Modified (TICS) Score

    3 months

  • Telephone Interview for Cognitive Status Modified (TICS) Score

    1 year

  • Hospital anxiety and depression scale (HADS) Score

    3 months

  • Hospital anxiety and depression scale (HADS) Score

    1 year

  • Fatigue Severity Scale (FSS) Score

    3 months

  • +5 more secondary outcomes

Interventions

Telephone InterviewOTHER

Telephone Interview

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

CH Agen

Agen, 47 923, France

Location

CH Blaye

Blaye, 33 394, France

Location

CHU Bordeaux

Bordeaux, 33 076, France

Location

CH Arcachon

La Teste-de-Buch, 33 164, France

Location

CH Sud Gironde - Langon

Langon, 33 212, France

Location

Clinique Mutualiste Lesparre Médoc

Lesparre-Médoc, 33 340, France

Location

CH Libourne

Libourne, 33 505, France

Location

CHIC Marmande-Tonneins

Marmande, 47 207, France

Location

CH Mont de Marsan - site Layné

Mont-de-Marsan, 40 024, France

Location

CH Oloron

Oloron-Sainte-Marie, 64 400, France

Location

CH Orthez

Orthez, 64 301, France

Location

CH Pau

Pau, 64 000, France

Location

Pôle de Santé du Villeneuvois

Villeneuve-sur-Lot, 47 305, France

Location

Related Publications (1)

  • 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.

    PMID: 31665006DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2019

First Posted

March 6, 2019

Study Start

November 18, 2019

Primary Completion

November 18, 2022

Study Completion

November 18, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(13)