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StrokeICEIPAVCNCT07524036

Impact of a Nursing Educational Consultation on the Patient's Adherence to Their Post-stroke Care Plan.

A study testing nursing educational consultation in people with Stroke and Patient Education, run by University Hospital, Bordeaux at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Patient Education
What is being tested?
nursing educational consultation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteFrance
Study dates
11 Jun 2026to 11 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting
  • Centre Hospitalier de la Côte Basque

    Bayonne, 64100

    GASSUAN Karine

    Recruiting

Other trials in France

About this study

Official title: Impact of a Nursing Consultation at the End of Hospitalization on Adherence to the Post-stroke Care Plan for Patients Admitted to the Vascular Neurology Unit

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.

Read the detailed description

Stroke is the leading cause of acquired disability in adults and represents a public health problem in terms of frequency, severity, and cost.

In France, the prevalence of stroke is estimated at 1.6%, with about 150,000 new cases each year. The risk of recurrence after a stroke remains high, nearly 6% at 1 year and 13% at 5 years. Some strokes and their recurrences are preventable through targeted prevention, particularly addressing cardiovascular risk factors.

The care pathway for a patient suffering from a stroke or TIA in a medical service includes:

  • acute care in stroke units, which allows more than half of patients to return home
  • a post-stroke consultation, 3 to 6 months after the stroke. According to the WHO, 50% of patients with chronic illnesses poorly adhere or adhere little to their treatments. Interventions are necessary to improve adherence to drug and rehabilitation therapies. They raise awareness of the risks of relapse through a better understanding of the disease and control of risk factors. Increased efforts to enhance awareness of stroke and secondary prevention drug treatments are warranted.

In the stroke care pathway, therapeutic education is an integral part of secondary prevention. It is an essential complement to the management of patients following a stroke and should be initiated as early as possible after the acute phase, hence during the stay in the neurological intensive care unit. However, ETP programs are scarce within general hospitals. Of about twenty programs listed in Nouvelle Aquitaine, only a quarter are accessible in general hospitals. The implementation of a nursing educational consultation, at the end of the acute management of the stroke, will allow for conveying the key messages of secondary prevention.

The investigators of this research propose to study the impact of this nursing educational consultation on the patient's adherence to their post-stroke care plan.

Being tested
nursing educational consultation
Keywords
stroke, patient education, post stroke consultation
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07524036
Study groupRoleWhat they receive
standard stroke care pathway GroupNo interventionThe 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 groupActive comparatorThe patients benefits from an additionnal nursing educational consultation at the end of hospitalization.
Receives: Other: nursing educational consultation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 months

Secondary outcomes (16)
  1. Description of the specfic therapeutic adherence

    Description of medication adherence by therapeutic class compared with prescriptions at hospital discharge, in both groups, based on patient self-report.

    Measured: 4 & 12 months

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

    Evaluation of the proportion of patients attending the post-stroke follow-up consultation in both groups.

    Measured: 4 & 12 months

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

    Evaluation of the proportion of rehabilitation interventions completed (physiotherapy and/or speech therapy), calculated relative to what was prescribed at hospital discharge (number of completed prescriptions per patient / number of prescribed rehabilitation interventions), in both groups, based on patient self-report.

    Measured: 4 & 12 months

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

    Evaluation of the proportion of prescribed post-stroke complementary investigations completed, calculated relative to what was prescribed at hospital discharge (number of completed tests / number of prescribed tests), in both groups based on patient self-report.

    Measured: 4 & 12 months

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

    Comparison of mean composite scores for overall adherence to the post-stroke care plan between the two groups : This composite score (range: 0-3), developed for this study, defines three adherence categories:

    • High adherence: score ≥ 2
    • Moderate adherence: score ≥ 1.5 to < 2
    • Low adherence: score < 1.5

    Measured: 4 & 12 months

  6. Assessment of the patient's knowledge about stroke

    Comparison of mean scores on the "My Stroke Knowledge" questionnaire between the two groups.

    This score assesses patient knowledge of essential stroke-related information. It was inspired by the Stroke Knowledge Score used in a study by Benoit C. conducted at Foch Hospital.

    A 2-item self-administered questionnaire [Appendix 2] was developed to assess:

    • Knowledge of main stroke warning signs (5 points)
    • Appropriate response in case of symptom onset (2 points) These two components will be analyzed separately, and changes in mean scores will be compared between groups.

    A score ≥5 (including the full 2 points for appropriate response) indicates very good stroke knowledge.

    Measured: 4 & 12 months

  7. Evaluation of secondary prevention and vascular risk factors (1)

    Proportion of patients with blood pressure within the target range:

    • Either ≤135mmHg/85mmHg based on the average of home blood pressure self-measurements
    • Or ≤140mmHg/90mmHg based on blood pressure measurements taken during consultations in both groups

    Measured: 4 & 12 months

  8. Evaluation of secondary prevention and vascular risk factors (2)

    Proportion of patients who achieved the target reduction of 1 mmol/L in LDL in both groups and description of the differences between the level measured at discharge and the levels measured during follow-up visits (in mmol/L), in both groups .

    Measured: 4 & 12 months

  9. Evaluation of secondary prevention and vascular risk factors (3)

    Proportion of patients diagnosed with diabetes via fasting blood glucose measurement in both groups Measure unit : g/l

    Measured: 4 & 12 months

  10. Evaluation of secondary prevention and vascular risk factors (4)

    Among diabetic patients: proportion of patients who achieved the personalised HbA1c target, in both groups Creatinine levels will be monitored as a simple follow-up, without a specific target to be achieved Measure unit : g/l

    Measured: 4 & 12 months

  11. Evaluation of secondary prevention and vascular risk factors (5)

    Proportion of patients who have completely stopped smoking (self-reported), in both groups

    Measured: 4 & 12 months

  12. Evaluation of secondary prevention and vascular risk factors (6)

    Mean difference in body mass index (BMI) between the two groups weight and height will be combined to report BMI in kg/m^2).

    Measured: 4 & 12 months

  13. Evaluation of post-stroke disability (1)

    Comparison of mean Stroke-Specific Quality of Life (SS-QOL) scores between groups. This patient-reported outcome assesses health-related quality of life specific to stroke. Patients respond based on the previous week.

    The total score (49-245) includes multiple domains (energy, family roles, language, mobility, mood, etc.). Each domain will be assessed at each visit and its evolution analyzed. Higher scores indicate better functioning .

    Measured: 4 & 12 months

  14. Evaluation of post-stroke disability (2)

    Comparison of mean Hospital Anxiety and Depression Scale (HADS) scores between groups.

    This validated instrument (French version available) screens for anxiety and depressive symptoms in post-stroke patients.

    It includes 14 items (scored 0-3):

    • 7 for anxiety
    • 7 for depression Scores ≥8 indicate possible symptoms, and ≥11 indicate definite symptoms. Scores will be assessed at each visit and their evolution analyzed

    Measured: 4 & 12 months

  15. Evaluation of post-stroke disability (3)

    Comparison of mean modified Rankin Scale (mRS) scores between groups. This scale (0-6) assesses disability and its impact on daily activities and return to normal life. Its evolution will be analyzed. A validated French structured interview version will be used

    Measured: 4 & 12 months

  16. Evaluation of post-stroke disability (4)

    Comparison of mean National Institutes of Health Stroke Scale (NIHSS) scores between groups.

    This scale (0-40) evaluates neurological deficit severity and is widely used in neurovascular practice. Lower scores indicate fewer neurological sequelae. Scores will be assessed at each visit and their evolution analyzed.

    Measured: 4 & 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2026
  2. Study start11 Jun 2026
  3. Primary completion11 Jun 2028 (estimated)
  4. Study completion11 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, monocentric, randomized study in two parallel groups (intervention group and control group)
Masking
Single blind
Who is masked
Care provider
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07524036
Sponsor's protocol ID
CHUBX 2024/112
Acronym
ICEIPAVC
Status last verified
Aug 2026
First submitted
23 Mar 2026
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing nursing educational consultation in people with Stroke and Patient Education, run by University Hospital, Bordeaux at 1 site 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 7 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact GASSUAN Karine (0033.5.33.78.82.29, kgassuan@ch-cotebasque.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of the proportion of patients with high adherence to their prescribed medications after stroke, upon returning home (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 18 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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