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

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ClinicalTrials.gov Identifier: NCT03865173

Recruitment Status : Unknown

Verified December 2019 by University Hospital, Bordeaux.
Recruitment status was: Recruiting

First Posted : March 6, 2019

Last Update Posted : December 19, 2019

Sponsor:

Information provided by (Responsible Party):

University Hospital, Bordeaux

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
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: 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).

Study Design

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Study Type :	Observational
Estimated Enrollment :	1210 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 :	November 18, 2019
Estimated Primary Completion Date :	November 18, 2021
Estimated Study Completion Date :	November 18, 2021

Groups and Cohorts

Intervention Details:

Other: Telephone Interview
Telephone Interview

Outcome Measures

Primary Outcome Measures :

Modified Rankin Scale (mRS) Score [ Time Frame: 3 months ]
Activity limitations post-stroke measure. Minimum score : 0 "No symptoms at all " Maximum score : 6 "Dead"
Modified Rankin Scale (mRS) Score [ Time Frame: 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 [ Time Frame: 3 months ]
Cognitive disorders post-stroke measure Score from 0 to 43
Telephone Interview for Cognitive Status Modified (TICS) Score [ Time Frame: 1 year ]
Cognitive disorders post-stroke measure Score from 0 to 43
Hospital anxiety and depression scale (HADS) Score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 3 months ]
Participation restrictions post-stroke measure Score from 0 to 35
Community Integration Questionnaire (CIQ-R) Score [ Time Frame: 1 year ]
Participation restrictions post-stroke measure Score from 0 to 35

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
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

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03865173

Contacts

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Contact: François Rouanet, Dr	05 56 79 55 20	francois.rouanet@chu-bordeaux.fr
Contact: Florence Saillour-Glenisson	05 57 57 13 93	florence.saillour@chu-bordeaux.fr

Locations

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France
CH Agen	Recruiting
Agen, France, 47 923
Contact: Jean-Marc FAUCHEUX, Dr 05 53 69 78 12 faucheuxjm@ch-agen-nerac.fr
CH Blaye	Recruiting
Blaye, France, 33 394
Contact: Laurent WONG SO, Dr 05 57 33 40 14 l.wongso@chblaye.fr
CHU Bordeaux	Recruiting
Bordeaux, France, 33 076
Contact: François ROUANET, Dr 05 56 79 55 20 francois.rouanet@chu-bordeaux.fr
CH Arcachon	Recruiting
La Teste de Buch, France, 33 164
Contact: Maria DAN, Dr 05 57 52 92 40 maria.dan@ch-arcachon.fr
CH Sud Gironde - Langon	Recruiting
Langon, France, 33 212
Contact: Véronique HOSTYN, Dr 05 56 76 57 57 veroniquehostyn@yahoo.fr
Clinique Mutualiste Lesparre Médoc	Recruiting
Lesparre-Médoc, France, 33 340
Contact: Shi Fei MA-MESNIEL, Dr 05 56 73 11 91 geriatrielesparre@pavillon-mutualite.fr
CH Libourne	Not yet recruiting
Libourne, France, 33 505
Contact: Philippe CASENAVE, Dr 05 57 55 70 08 philippe.casenave@ch-libourne.fr
CHIC Marmande-Tonneins	Recruiting
Marmande, France, 47 207
Contact: Gaëlle SEIGNOLLES, Dr 05 53 20 30 40 gaelle@seignolles.com
CH Mont de Marsan - site Layné	Recruiting
Mont de Marsan, France, 40 024
Contact: Basile ONDZE, Dr 05 58 05 17 92 basile.ondze@ch-mdm.fr
CH Oloron	Recruiting
Oloron-Sainte-Marie, France, 64 400
Contact: Isabelle ARGACHA, Dr 05 59 88 30 30 isabelle.argacha@ch-oloron.fr
CH Orthez	Recruiting
Orthez, France, 64 301
Contact: Philippe HUTHER, Dr 05 59 69 73 73 philippe.huther@ch-orthez.fr
CH Pau	Recruiting
Pau, France, 64 000
Contact: Stéphanie DEMASLES, Dr 05 59 92 72 19 stephanie.demasles@ch-pau.fr
Pôle de Santé du Villeneuvois	Recruiting
Villeneuve sur Lot, France, 47 305
Contact: Christine BARTOU, Dr 05 53 72 25 53 christine.bartou@psv47.fr

Sponsors and Collaborators

University Hospital, Bordeaux

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Broussy S, Rouanet F, Lesaine E, Domecq S, Kret M, Maugeais M, Aly F, Dehail P, Bénard 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.

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Responsible Party:	University Hospital, Bordeaux
ClinicalTrials.gov Identifier:	NCT03865173
Other Study ID Numbers:	CHUBX 2016/30
First Posted:	March 6, 2019 Key Record Dates
Last Update Posted:	December 19, 2019
Last Verified:	December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by University Hospital, Bordeaux:


Stroke Pathways Sequelae Health services research

Additional relevant MeSH terms:

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Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases	Nervous System Diseases Vascular Diseases Cardiovascular Diseases

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