StrokePAPASéPANCT03865173
Post-stroke Pathway: Analysis and Link With One Year Sequelae in a French Cohort of Stroke Patients
An observational study of Stroke and Stroke Sequelae, run by University Hospital, Bordeaux at 13 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Stroke Sequelae
- What is being tested?
- Telephone Interview
- How many people
- 1,138 participants
- Where
- 13 sitesFrance
- Study dates
- 18 Nov 2019to 18 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patient refuse to participate to PAPASéPA
- Patient died during the initial stay
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
CH Agen
Agen, 47 923
CH Blaye
Blaye, 33 394
CHU Bordeaux
Bordeaux, 33 076
CH Arcachon
La Teste-de-Buch, 33 164
CH Sud Gironde - Langon
Langon, 33 212
Clinique Mutualiste Lesparre Médoc
Lesparre-Médoc, 33 340
CH Libourne
Libourne, 33 505
CHIC Marmande-Tonneins
Marmande, 47 207
CH Mont de Marsan - site Layné
Mont-de-Marsan, 40 024
CH Oloron
Oloron-Sainte-Marie, 64 400
CH Orthez
Orthez, 64 301
CH Pau
Pau, 64 000
Pôle de Santé du Villeneuvois
Villeneuve-sur-Lot, 47 305
About this study
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.
Read the 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).
- Conditions
- Stroke, Stroke Sequelae
- Being tested
- Telephone Interview
- Keywords
- Stroke, Pathways, Sequelae, Health services research
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone InterviewOther
Telephone Interview
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale (mRS) Score
Activity limitations post-stroke measure. Minimum score : 0 "No symptoms at all " Maximum score : 6 "Dead"
Measured: 3 months
Modified Rankin Scale (mRS) Score
Activity limitations post-stroke measure Minimum score : 0 "no symptom" Maximum score : 6 "death"
Measured: 1 year
Secondary outcomes (10)
Telephone Interview for Cognitive Status Modified (TICS) Score
Cognitive disorders post-stroke measure Score from 0 to 43
Measured: 3 months
Telephone Interview for Cognitive Status Modified (TICS) Score
Cognitive disorders post-stroke measure Score from 0 to 43
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 1 year
Community Integration Questionnaire (CIQ-R) Score
Participation restrictions post-stroke measure Score from 0 to 35
Measured: 3 months
Community Integration Questionnaire (CIQ-R) Score
Participation restrictions post-stroke measure Score from 0 to 35
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start18 Nov 2019
- Primary completion18 Nov 2022 (estimated)
- Study completion18 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865173
- Sponsor's protocol ID
- CHUBX 2016/30
- Acronym
- PAPASéPA
- Status last verified
- Mar 2022
- First submitted
- 22 Feb 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31665006
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-stroke Pathway: Analysis and Link With One Year Sequelae in a French Cohort of Stroke Patients
- ClinicalTrials.gov ID
- NCT03865173
- Acronym / sponsor ID
- PAPASéPA / CHUBX 2016/30
- Conditions
- Stroke, Stroke Sequelae
- Keywords
- Stroke, Pathways, Sequelae, Health services research
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,138 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 18 Nov 2022 (estimated)
- Study completion
- 18 Nov 2022 (estimated)
- First posted
- 6 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Patient refuse to participate to PAPASéPA
- Patient died during the initial stay
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone InterviewTelephone Interview | Other | – |
Primary outcome
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"
10 secondary outcomes
Telephone Interview for Cognitive Status Modified (TICS) Score
Time frame: 3 months
Telephone Interview for Cognitive Status Modified (TICS) Score
Time frame: 1 year
Hospital anxiety and depression scale (HADS) Score
Time frame: 3 months
Hospital anxiety and depression scale (HADS) Score
Time frame: 1 year
Fatigue Severity Scale (FSS) Score
Time frame: 3 months
Fatigue Severity Scale (FSS) Score
Time frame: 1 year
Barthel Index (BI) Score
Time frame: 3 months
Barthel Index (BI) Score
Time frame: 1 year
Community Integration Questionnaire (CIQ-R) Score
Time frame: 3 months
Community Integration Questionnaire (CIQ-R) Score
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 31665006Broussy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Stroke Sequelae, run by University Hospital, Bordeaux at 13 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (mRS) Score (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03865173, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.