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| Name | Class |
|---|---|
| Centre Hospitalier de la côte Basque | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nursing educational consultation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 & 12 months |
| Evaluation of Patient adherence to the post-stroke care plan (1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| GASSUAN Karine | Contact | 0033.5.33.78.82.29 | kgassuan@ch-cotebasque.fr | |
| BERNADY Patricia, Dr | Contact | 0033.5.59.44.32.67 | pbernady@ch-cotebasque.fr |
| Name | Affiliation | Role |
|---|---|---|
| GASSUAN Karine | Centre Hospitalier de la côte Basque | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de la Côte Basque | Bayonne | 64100 | France |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Prospective, monocentric, randomized study in two parallel groups (intervention group and control group)
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Evaluation of the proportion of patients attending the post-stroke follow-up consultation in both groups. |
| 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. | 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. | 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:
| 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:
A score ≥5 (including the full 2 points for appropriate response) indicates very good stroke knowledge. | 4 & 12 months |
| Evaluation of secondary prevention and vascular risk factors (1) | Proportion of patients with blood pressure within the target range:
| 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 . | 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 | 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 | 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 | 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). | 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 . | 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):
| 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 | 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. | 4 & 12 months |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |