NCT07524036

Brief Summary

This prospective, single-center, randomized study will evaluate the impact of implementing an educational nursing consultation at the end of hospitalisation for stroke patients returning home on overall adherence to stroke-related medication during the 4-month follow-up visit.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable stroke

Timeline
23mo left

Started Apr 2026

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Apr 2026Apr 2028

First Submitted

Initial submission to the registry

March 23, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2028

Last Updated

April 13, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

March 23, 2026

Last Update Submit

April 9, 2026

Conditions

StrokePatient Education

Keywords

strokepatient educationpost stroke consultation

Outcome Measures

Primary Outcomes (1)

  • Measurement of the proportion of patients with high adherence to their prescribed medications after stroke, upon returning home

    The adherence will be evaluate using the 8-item Morisky Medication Adherence Scale (MMAS-8), in both arms. The MMAS-8 will provide an overall assessment of all treatments prescribed in the context of stroke. This score is an 8-item self-administered questionnaire, validated in French, intended for adults, which allows patients to be classified into three groups according to their score: * High adherence: score = 8 * Moderate adherence: score from 6 to \<8 * Low adherence: score \< 6 For the primary analysis, adherence will be considered as a binary outcome: high adherence versus moderate or low adherence.

    4 months

Secondary Outcomes (16)

  • Description of the specfic therapeutic adherence

    4 & 12 months

  • Evaluation of Patient adherence to the post-stroke care plan (1)

    4 & 12 months

  • Evaluation of Patient adherence to the post-stroke care plan (2)

    4 & 12 months

  • Evaluation of Patient adherence to the post-stroke care plan (3)

    4 & 12 months

  • Evaluation of Patient adherence to the post-stroke care plan (4)

    4 & 12 months

  • +11 more secondary outcomes

Study Arms (2)

standard stroke care pathway Group

NO INTERVENTION

The patients will benefit from the usual care provided by the unit, specifically adapted for patients being discharged home following a stroke.

additionnal educational nursing consultation group

ACTIVE COMPARATOR

The patients benefits from an additionnal nursing educational consultation at the end of hospitalization.

Other: nursing educational consultation

Interventions

nursing educational consultationOTHER

At the end of hospitalization, the patient will receive a nursing education consultation prior to discharge. This consultation will provide personalized information regarding stroke pathology, its mechanisms and etiology, medication treatments, personal vascular risk factors, and the implementation of the care plan (rehabilitation, additional examinations). Discharge documents are provided at the end of this consultation.

additionnal educational nursing consultation group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted to the Neurovascular Unit (UNV) of CHCB for ischemic stroke and/or hemorrhagic stroke confirmed by brain imaging and/or TIA with an ABCD2 score \>5,
  • Patients whose discharge orientation is a return home
  • Age ≥ 18 years
  • NIHSS \< 15
  • Montreal Cognitive Assessment (MoCa) \> 21/30
  • Free and informed consent signed by the patient.
  • Person affiliated with or a beneficiary of a social security scheme

You may not qualify if:

  • Patients admitted for mechanical thrombectomy, outside the Basque Coast Hospital (CHCB)
  • Rankin score estimated at discharge ≥ 4
  • Patients requiring assistance from a third party at home for the management of their medication or with stroke follow-up at Prado
  • Patients placed under protection measures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de la Côte Basque

Bayonne, 64100, France

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • GASSUAN Karine

    Centre Hospitalier de la côte Basque

    PRINCIPAL INVESTIGATOR

Central Study Contacts

GASSUAN Karine

CONTACT

0033.5.33.78.82.29kgassuan@ch-cotebasque.fr

BERNADY Patricia, Dr

CONTACT

0033.5.59.44.32.67pbernady@ch-cotebasque.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Prospective, monocentric, randomized study in two parallel groups (intervention group and control group)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2026

First Posted

April 13, 2026

Study Start

April 15, 2026

Primary Completion (Estimated)

April 15, 2028

Study Completion (Estimated)

April 15, 2028

Last Updated

April 13, 2026

Record last verified: 2026-03

Locations

FR(1)