Post-stroke Pathway: Analysis and Link With One Year Sequelae in a French Cohort of Stroke Patients
- Conditions
- Stroke SequelaeStroke
- Registration Number
- NCT03865173
- Lead Sponsor
- University Hospital, Bordeaux
- 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1138
- 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
- Patient refuse to participate to PAPASéPA
- Patient died during the initial stay
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Modified Rankin Scale (mRS) Score 1 year Activity limitations post-stroke measure Minimum score : 0 "no symptom" Maximum score : 6 "death"
- Secondary Outcome Measures
Name Time Method 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 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 42Fatigue 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 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 100Community Integration Questionnaire (CIQ-R) Score 1 year Participation restrictions post-stroke measure Score from 0 to 35
Trial Locations
- Locations (13)
CH Agen
🇫🇷Agen, France
CH Blaye
🇫🇷Blaye, France
CH Arcachon
🇫🇷La Teste de Buch, France
Clinique Mutualiste Lesparre Médoc
🇫🇷Lesparre-Médoc, France
CH Mont de Marsan - site Layné
🇫🇷Mont de Marsan, France
CH Orthez
🇫🇷Orthez, France
CH Oloron
🇫🇷Oloron-Sainte-Marie, France
CH Pau
🇫🇷Pau, France
Pôle de Santé du Villeneuvois
🇫🇷Villeneuve sur Lot, France
CH Libourne
🇫🇷Libourne, France
CHU Bordeaux
🇫🇷Bordeaux, France
CH Sud Gironde - Langon
🇫🇷Langon, France
CHIC Marmande-Tonneins
🇫🇷Marmande, France