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

Stroke Clinical Trial

— PAPASéPA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03865173
• Other study ID #: CHUBX 2016/30
• Status: Active, not recruiting
• Start date: November 18, 2019
• Est. completion date: November 18, 2022

Study information

• Verified date: March 2022
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1138
• Est. completion date: November 18, 2022
• Est. primary completion date: November 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Stroke Sequelae

Intervention

Other:
• Telephone Interview
Telephone Interview

Locations

Country	Name	City	State
France	CH Agen	Agen
France	CH Blaye	Blaye
France	CHU Bordeaux	Bordeaux
France	CH Arcachon	La Teste de Buch
France	CH Sud Gironde - Langon	Langon
France	Clinique Mutualiste Lesparre Médoc	Lesparre-Médoc
France	CH Libourne	Libourne
France	CHIC Marmande-Tonneins	Marmande
France	CH Mont de Marsan - site Layné	Mont de Marsan
France	CH Oloron	Oloron-Sainte-Marie
France	CH Orthez	Orthez
France	CH Pau	Pau
France	Pôle de Santé du Villeneuvois	Villeneuve sur Lot

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rankin Scale (mRS) Score	Activity limitations post-stroke measure. Minimum score : 0 "No symptoms at all " Maximum score : 6 "Dead"	3 months
Primary	Modified Rankin Scale (mRS) Score	Activity limitations post-stroke measure Minimum score : 0 "no symptom" Maximum score : 6 "death"	1 year
Secondary	Telephone Interview for Cognitive Status Modified (TICS) Score	Cognitive disorders post-stroke measure Score from 0 to 43	3 months
Secondary	Telephone Interview for Cognitive Status Modified (TICS) Score	Cognitive disorders post-stroke measure Score from 0 to 43	1 year
Secondary	Hospital anxiety and depression scale (HADS) Score	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	3 months
Secondary	Hospital anxiety and depression scale (HADS) Score	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	1 year
Secondary	Fatigue Severity Scale (FSS) Score	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.	3 months
Secondary	Fatigue Severity Scale (FSS) Score	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.	1 year
Secondary	Barthel Index (BI) Score	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	3 months
Secondary	Barthel Index (BI) Score	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	1 year
Secondary	Community Integration Questionnaire (CIQ-R) Score	Participation restrictions post-stroke measure Score from 0 to 35	3 months
Secondary	Community Integration Questionnaire (CIQ-R) Score	Participation restrictions post-stroke measure Score from 0 to 35	1 year