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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; Patient Education
• Intervention / Treatment: Other: nursing educational consultation

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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: GASSUAN Karine; Phone Number: 0033.5.33.78.82.29; Email: kgassuan@ch-cotebasque.fr
• Study Contact Backup: Name: BERNADY Patricia, Dr; Phone Number: 0033.5.59.44.32.67; Email: pbernady@ch-cotebasque.fr

Study Locations

• France
  • Bayonne, France, 64100
    • Centre Hospitalier de la Cote Basque
    • Contact: GASSUAN Karine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: standard stroke care pathway Group; The patients will benefit from the usual care provided by the unit, specifically adapted for patients being discharged home following a stroke.
Active Comparator: additionnal educational nursing consultation group; The patients benefits from an additionnal nursing educational consultation at the end of hospitalization.	Other: nursing educational consultation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: 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 Outcome Measures

Outcome Measure	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)	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: High adherence: score ≥ 2; Moderate adherence: score ≥ 1.5 to < 2; Low adherence: score < 1.5	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.	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	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): 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	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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: Centre Hospitalier de la côte Basque
• Investigators: Principal Investigator: GASSUAN Karine, Centre Hospitalier de la Cote Basque

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): April 15, 2028
• Study Completion (Estimated): April 15, 2028

Study Registration Dates

• First Submitted: March 23, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: stroke; patient education; post stroke consultation
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: CHUBX 2024/112

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No