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.
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
- Recruiting
Centre Hospitalier de la Côte Basque
Bayonne, 64100
GASSUAN Karine
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.
- Conditions
- Stroke, Patient Education
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: nursing educational consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted13 Apr 2026
- Study start11 Jun 2026
- Primary completion11 Jun 2028 (estimated)
- Study completion11 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier de la côte Basque
- Responsible party
- Sponsor
- Investigators
- GASSUAN Karine, Principal investigator, Centre Hospitalier de la côte Basque
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07524036
- Acronym / sponsor ID
- ICEIPAVC / CHUBX 2024/112
- Conditions
- Stroke, Patient Education
- Keywords
- stroke, patient education, post stroke consultation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Centre Hospitalier de la côte Basque
- Study start
- 11 Jun 2026 (actual)
- Primary completion
- 11 Jun 2028 (estimated)
- Study completion
- 11 Jun 2028 (estimated)
- First posted
- 13 Apr 2026 (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.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Prospective, monocentric, randomized study in two parallel groups (intervention group and control group)
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: nursing educational consultationThe patients benefits from an additionnal nursing educational consultation at the end of hospitalization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| nursing educational consultationAt 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. | Other | additionnal educational nursing consultation group |
Primary outcome
Measurement of the proportion of patients with high adherence to their prescribed medications after stroke, upon returning home
Time frame: 4 months
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.
16 secondary outcomes
Description of the specfic therapeutic adherence
Time frame: 4 & 12 months
Evaluation of Patient adherence to the post-stroke care plan (1)
Time frame: 4 & 12 months
Evaluation of Patient adherence to the post-stroke care plan (2)
Time frame: 4 & 12 months
Evaluation of Patient adherence to the post-stroke care plan (3)
Time frame: 4 & 12 months
Evaluation of Patient adherence to the post-stroke care plan (4)
Time frame: 4 & 12 months
Assessment of the patient's knowledge about stroke
Time frame: 4 & 12 months
Evaluation of secondary prevention and vascular risk factors (1)
Time frame: 4 & 12 months
Evaluation of secondary prevention and vascular risk factors (2)
Time frame: 4 & 12 months
Evaluation of secondary prevention and vascular risk factors (3)
Time frame: 4 & 12 months
Evaluation of secondary prevention and vascular risk factors (4)
Time frame: 4 & 12 months
Evaluation of secondary prevention and vascular risk factors (5)
Time frame: 4 & 12 months
Evaluation of secondary prevention and vascular risk factors (6)
Time frame: 4 & 12 months
Evaluation of post-stroke disability (1)
Time frame: 4 & 12 months
Evaluation of post-stroke disability (2)
Time frame: 4 & 12 months
Evaluation of post-stroke disability (3)
Time frame: 4 & 12 months
Evaluation of post-stroke disability (4)
Time frame: 4 & 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
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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.
GASSUAN Karine principal investigator
Centre Hospitalier de la côte Basque
1 site in 1 country: see every site and its status.
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.