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Post-stroke Pathway: Analysis and Link With One Year Sequelae in a French Cohort of Stroke Patients

Post-stroke Pathway: Analysis and Link With One Year Sequelae in a French Cohort of Stroke Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03865173
Acronym
PAPASéPA
Enrollment
1138
Registered
2019-03-06
Start date
2019-11-18
Completion date
2022-11-18
Last updated
2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Stroke Sequelae

Keywords

Stroke, Pathways, Sequelae, Health services research

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).

Interventions

OTHERTelephone Interview

Telephone Interview

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Modified Rankin Scale (mRS) Score3 monthsActivity limitations post-stroke measure. Minimum score : 0 No symptoms at all Maximum score : 6 Dead

Secondary

MeasureTime frameDescription
Telephone Interview for Cognitive Status Modified (TICS) Score3 monthsCognitive disorders post-stroke measure Score from 0 to 43
Hospital anxiety and depression scale (HADS) Score3 monthsDepression and anxiety disorders post-stroke measure Scores ranged from 0 (minimum) to 21 (maximum) for anxiety and 0 (minimum) to 21 (maximum) for depression. Total score from 0 to 42
Fatigue Severity Scale (FSS) Score3 monthsThe Fatigue Severity Scale (FSS) is designed to differentiate fatigue from clinical depression, since both share some of the same symptoms. Essentially, the FSS consists of answering a short questionaire that requires the subject to rate his or her own level of fatigue. The subject is asked to read each statem ent and circle a number from 1 to 7, depending on how appropriate they felt the statement applied to them over the preceding week. A low value indicates that the statement is not very appropriate whereas a high value indicates agreement. The scoring is done by calculating the average response to the questions (adding up all the answers and dividing by nine). People with depression alone score about 4.5. People with fatigue average about 6.5.
Barthel Index (BI) Score3 monthsFunctional outcome post-stroke measure The original 10-item form of the BI consists of 10 common ADL activities including: feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing. Items are rated in terms of whether individuals can perform activities independently, with some assistance, or are dependent (scored as 10, 5 or 0). Items are weighted according to the level of nursing care required. Total score from 0 to 100
Community Integration Questionnaire (CIQ-R) Score3 monthsParticipation restrictions post-stroke measure Score from 0 to 35

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026