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

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03865173

Collaborator

(none)

1,138

Enrollment

Locations

Anticipated Duration (Months)

87.5

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Stroke Sequelae	Other: Telephone Interview

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:

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).

Study Design

Study Type:

Observational

Actual Enrollment :

1138 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 18, 2019

Anticipated Primary Completion Date :

Nov 18, 2022

Anticipated Study Completion Date :

Nov 18, 2022

Outcome Measures

Primary Outcome Measures

Modified Rankin Scale (mRS) Score [3 months]
Activity limitations post-stroke measure. Minimum score : 0 "No symptoms at all " Maximum score : 6 "Dead"
Modified Rankin Scale (mRS) Score [1 year]
Activity limitations post-stroke measure Minimum score : 0 "no symptom" Maximum score : 6 "death"

Secondary Outcome Measures

Telephone Interview for Cognitive Status Modified (TICS) Score [3 months]
Cognitive disorders post-stroke measure Score from 0 to 43
Telephone Interview for Cognitive Status Modified (TICS) Score [1 year]
Cognitive disorders post-stroke measure Score from 0 to 43
Hospital anxiety and depression scale (HADS) Score [3 months]
Depression 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
Hospital anxiety and depression scale (HADS) Score [1 year]
Depression 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) Score [3 months]
The 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.
Fatigue Severity Scale (FSS) Score [1 year]
The 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) Score [3 months]
Functional 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
Barthel Index (BI) Score [1 year]
Functional 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) Score [3 months]
Participation restrictions post-stroke measure Score from 0 to 35
Community Integration Questionnaire (CIQ-R) Score [1 year]
Participation restrictions post-stroke measure Score from 0 to 35

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CH Agen	Agen	France	47 923
2	CH Blaye	Blaye	France	33 394
3	CHU Bordeaux	Bordeaux	France	33 076
4	CH Arcachon	La Teste de Buch	France	33 164
5	CH Sud Gironde - Langon	Langon	France	33 212
6	Clinique Mutualiste Lesparre Médoc	Lesparre-Médoc	France	33 340
7	CH Libourne	Libourne	France	33 505
8	CHIC Marmande-Tonneins	Marmande	France	47 207
9	CH Mont de Marsan - site Layné	Mont de Marsan	France	40 024
10	CH Oloron	Oloron-Sainte-Marie	France	64 400
11	CH Orthez	Orthez	France	64 301
12	CH Pau	Pau	France	64 000
13	Pôle de Santé du Villeneuvois	Villeneuve sur Lot	France	47 305

Sponsors and Collaborators

University Hospital, Bordeaux

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Bordeaux

ClinicalTrials.gov Identifier:

NCT03865173

Other Study ID Numbers:

CHUBX 2016/30

First Posted:

Mar 6, 2019

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Bordeaux

Stroke

Pathways

Sequelae

Health services research

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Mar 31, 2022