Centre Hospitalier de la Côte Basque
Bayonne, 64100, France
Location contact
GASSUAN Karine
CONTACT
NCT Number: NCT07524036
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 opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Bayonne, 64100, France
GASSUAN Karine
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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:
Time frame: 4 & 12 months
Description of medication adherence by therapeutic class compared with prescriptions at hospital discharge, in both groups, based on patient self-report.
Time frame: 4 & 12 months
Evaluation of the proportion of patients attending the post-stroke follow-up consultation in both groups.
Time frame: 4 & 12 months
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.
Time frame: 4 & 12 months
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.
Time frame: 4 & 12 months
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:
Time frame: 4 & 12 months
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.
Time frame: 4 & 12 months
Proportion of patients with blood pressure within the target range:
Time frame: 4 & 12 months
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 .
Time frame: 4 & 12 months
Proportion of patients diagnosed with diabetes via fasting blood glucose measurement in both groups Measure unit : g/l
Time frame: 4 & 12 months
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
Time frame: 4 & 12 months
Proportion of patients who have completely stopped smoking (self-reported), in both groups
Time frame: 4 & 12 months
Mean difference in body mass index (BMI) between the two groups weight and height will be combined to report BMI in kg/m^2).
Time frame: 4 & 12 months
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 .
Time frame: 4 & 12 months
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):
Time frame: 4 & 12 months
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
Time frame: 4 & 12 months
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.
Contact information is provided by the study sponsor or research team.
BERNADY Patricia, Dr
CONTACT
GASSUAN Karine
CONTACT
University Hospital, Bordeaux
Other
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
Acronym: ICEIPAVC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07736794
Behavior, Brain Diseases
Zaragoza, Spain
View Trial DetailsNCT07735676
Brain Diseases, Cardiovascular Diseases
Dhaka, Bangladesh
View Trial DetailsNCT07735338
Brain Diseases, Cardiovascular Diseases
Stanford, California, United States
View Trial DetailsNCT07735702
Brain Diseases, Cardiovascular Diseases
Dhaka, Bangladesh
View Trial Details