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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke; Stroke Sequelae
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 1138

Contacts and Locations

Study Locations

• France
  • Agen, France, 47 923
    • CH Agen
  • Blaye, France, 33 394
    • CH Blaye
  • Bordeaux, France, 33 076
    • CHU Bordeaux
  • La Teste de Buch, France, 33 164
    • CH Arcachon
  • Langon, France, 33 212
    • CH Sud Gironde - Langon
  • Lesparre-Médoc, France, 33 340
    • Clinique Mutualiste Lesparre Médoc
  • Libourne, France, 33 505
    • CH Libourne
  • Marmande, France, 47 207
    • CHIC Marmande-Tonneins
  • Mont de Marsan, France, 40 024
    • CH Mont de Marsan - site Layné
  • Oloron-Sainte-Marie, France, 64 400
    • CH Oloron
  • Orthez, France, 64 301
    • CH Orthez
  • Pau, France, 64 000
    • CH Pau
  • Villeneuve sur Lot, France, 47 305
    • Pôle de Santé du Villeneuvois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Telephone Interview for Cognitive Status Modified (TICS) Score	Cognitive disorders post-stroke measure Score from 0 to 43	3 months
Telephone Interview for Cognitive Status Modified (TICS) Score	Cognitive disorders post-stroke measure Score from 0 to 43	1 year
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
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
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
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
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
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
Community Integration Questionnaire (CIQ-R) Score	Participation restrictions post-stroke measure Score from 0 to 35	3 months
Community Integration Questionnaire (CIQ-R) Score	Participation restrictions post-stroke measure Score from 0 to 35	1 year

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 18, 2019
• Primary Completion (ANTICIPATED): November 18, 2022
• Study Completion (ANTICIPATED): November 18, 2022

Study Registration Dates

• First Submitted: February 22, 2019
• First Submitted That Met QC Criteria: March 5, 2019
• First Posted (ACTUAL): March 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Stroke; Health services research; Sequelae; Pathways
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: CHUBX 2016/30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No