Hidden Impairments During Subarachnoid Haemorrhage Recovery, Description and Evolution of a Newly Described Syndrom

NCT06276517 | Not Yet Recruiting

• 2 other identifiers: APHP2209182022-A01739-34
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Descriptive observational study in patients with spontaneous subarachnoid hemorrhage or following aneurysmal rupture to assess the presence of a post-HSA syndrome at 3 months, 6 months and 1 year, and its impact on functional outcome using the Rivermead questionnaire

Conditions

Intracranial Hemorrhages

Keywords

post-HSA syndrome; subarachnoid hemorrhage

Outcome Measures

Primary Outcomes (1)

• Evaluate the presence of post SAH syndrome at 3 months and its impact on return to work using the Rivermead Post-Concussion symptoms questionnaire (RPQ), and its impact on functional outcome.

  The Rivermead questionnaire is a 16-item self-administered questionnaire, rated from 0 to 4, giving a total of 0 to 52 points. This scale was created to assess post-concussion syndrome, which in many ways is similar to what patients experience after a SAH. The higher the score, the greater the difficulties experienced by the patient. A score of 3 or 4 for any of the responses indicates that the patient is incapacitated.

  3 months

Secondary Outcomes (3)

• - study the factors determining the presence of a post-HSA syndrome and an inability to return to work at 3 months, 6 months and 1 year

  3 months, 6 months and 1 year,

• To study the prevalence of post-traumatic stress in this population

  3 months, 6 months and 1 year,

• Study patients' coping strategies in relation to functional recovery using the Brief-Cope self-questionnaire

  3 months, 6 months and 1 year,

Study Arms (1)

patients with subarachnoid hemorrhage

Patients hospitalized in Lariboisière intensive care unit for subarachnoid hemorrhage

Other: questionnaire; Other: SS-QoL; Other: SF-36; Other: CIQ-R; Diagnostic Test: BREFF; Diagnostic Test: MoCA; Other: IADL; Other: mMRS; Other: PCL-5; Other: Brief-Cope

Interventions

questionnaire OTHER

self-questionnaire with 16 questions, rated from 0 to 4, giving a total of 0 to 52 points.

Also known as: Rivermead Post-Concussion symptoms questionnaire (RPQ)

patients with subarachnoid hemorrhage

SS-QoL OTHER

49-question self-administered questionnaire covering 12 domains (including work/productivity, mood, social roles, family roles, personality, etc.).

Also known as: qustionnaire

patients with subarachnoid hemorrhage

SF-36 OTHER

multidimensional, generic scale, i.e. one that assesses health status independently of causal pathology, sex, age and treatment

Also known as: questionnaire

patients with subarachnoid hemorrhage

CIQ-R OTHER

16-question questionnaire with answers rated from 0 to 2 to assess Social reintegration

Also known as: questionnaire

patients with subarachnoid hemorrhage

BREFF DIAGNOSTIC_TEST

rapid frontal efficiency battery, 6 tests from 0 to 3 on each side

patients with subarachnoid hemorrhage

MoCA DIAGNOSTIC_TEST

MoCA is a screening test for neurocognitive impairment. It comprises 11 categories scored from 0 to 6 for a total of 0 to 30 points.

patients with subarachnoid hemorrhage

IADL OTHER

8 questions rated from 0 to 1 to assess functional outcome

Also known as: questionnaire

patients with subarachnoid hemorrhage

mMRS OTHER

mMRS score from 0 to 4 to assess functional outcome

Also known as: questionnaire

patients with subarachnoid hemorrhage

PCL-5 OTHER

To assess the prevalence of post-traumatic stress using the PCL-5 self-questionnaire. PCL-5 is a 20-item self-administered questionnaire.

Also known as: questionnaire

patients with subarachnoid hemorrhage

Brief-Cope OTHER

28-question self-questionnaires to study patients' coping strategies

Also known as: questionnaire

patients with subarachnoid hemorrhage

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18 to 65 who had presented with an episode of spontaneous subarachnoid haemorrhage or aneurysmal rupture, excluding meningeal haemorrhage due to trauma,

You may qualify if:

• Patient aged 18 to 65
• Patient hospitalized in intensive care unit at Hôpital Lariboisière between September 2022 and September 2023 for subarachnoid hemorrhage due to aneurysmal rupture.
• Patient affiliated to the French social security system
• Patient expressing no objection

You may not qualify if:

• Motor deficits persisting 1 month after SAH
• Hospitalization \> 1 month
• Patient does not speak French
• Patient with diagnosis of neurodegenerative disease.
• Traumatic meningeal hemorrhage
• Patients on AME

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Intracranial Hemorrhages; Subarachnoid Hemorrhage

Interventions

Surveys and Questionnaires; Coping Orientation to Problems Experienced Questionnaire

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Labeyrie Marc-Antoine

CONTACT

01 49 95 83 52; marc-antoine.labeyrie@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: February 26, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share