Clinical trial NCT02611440: Impact of a Pluriprofessional Intervention to Improve Medication Adherence (Secondary Preventive Medication) in Patients After Ischemic Stroke
Official title: Impact of a Pluriprofessional Intervention to Improve Medication Adherence (Secondary Preventive Medication) in Patients After Ischemic Stroke (ADMED-AVC)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Stroke
Keywords: ischemic stroke
medication adherence
cardiovascular disease prevention
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Medication adherence is a major factor to prevent vascular recurrence after a first ischemic stroke. Nevertheless, it is suboptimal and the implementation of specific interventions are needed to improve it.

A patient - centered and pluriprofessional structured intervention, targeting the medication, introduced at hospital discharge and continued at home (by regular telephone contact) could improve medication adherence one year after stroke.

This intervention would consist of semi structured interviews patient-pharmacist at different times during one year after stroke. The information about the therapeutic management of the patient will be shared between healthcare professionals : general practitioners (GP) and community pharmacists (CP), hospital clinical pharmacist (HCP) and physician (HPhys).

It will allow for decrease of the recurrent stroke and others cardiovascular complications based on a better adherence to preventive medication. Furthermore the decrease of the iatrogenic events and the improvement of the quality of life of patients may be also associated.


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years
* Patient with ischemic stroke hospitalized in physical medicine and rehabilitation unit or neurovascular unit
* Return at home at the hospital discharge
* Medication including an antiplatelet drug or an oral anticoagulant with at least an antihypertensive drug and/or a lipid lowering agent (statin)
* Patient without either cognitive disorders or major psychiatric disorders
* Patient with a sufficient autonomy for the management of medication at home (score of Barthel \> 30)

Exclusion Criteria:

* Patient ≤ 18 years
* Patient with important cognitive or psychiatric disorders
* Management of patient medication exclusively by the helper
* No usual pharmacy (or more than 2 usual pharmacies)
* Patient directed to an institution at the end of the hospitalization

Primary outcomes:
measure: Measure of patient's adherence to medication. This adherence measurement is a composite measure
timeFrame: One year after inclusion
Secondary outcomes:
measure: Analysis of pharmacy refills
timeFrame: 1 year after inclusion
measure: Percentage of patients with drug-related iatrogenic events
timeFrame: 1 year after inclusion
measure: Percentage of patients with a new stroke or cardiovascular event
timeFrame: 1 year after inclusion
measure: Percentage of patients readmitted in hospitalization
timeFrame: 1 year after the inclusion
measure: Realization of a questionnaire (Likert-type scale)
timeFrame: 1 year after inclusion
measure: Measure of glycemic and lipid balance.
timeFrame: 1 year after inclusion
measure: Realization of a questionnaire scoring (SF-36 scale)
timeFrame: 1 year after inclusion
measure: Realization of a questionnaire (Brief IPQR)
timeFrame: 1 year after inclusion
measure: Brief IPQR score and medication adherence (treatment adherence score and pharmacy refills) correlation (composite measure)
timeFrame: 1 year after inclusion
measure: Realization of questionnaires (Likert-type scale and SATMED) assessment of satisfaction of patients
timeFrame: 1 year after inclusion
measure: Realization of a questionnaire (Likert-type scale) assessment of satisfaction of GP and CP in relation to ADMED-AVC program.
timeFrame: 1 year after inclusion
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de neurologie vasculaire, Hôpital P Wertheimer, HCL
city: Cébazat
country: France
facility: Service de médecine physique et de réadaptation, Hôpital Nord, CHU de Clermont Ferrand
city: Echirolles
country: France
facility: Service de médecine physique et de réadaptation, Hôpital sud, CHU de Grenoble
city: Paris
country: France
facility: Service de médecine physique et de réadaptation, Groupe hospitalier Lariboisière - Fernand Vidal, AP-HP
city: Saint Genis Laval
country: France
facility: Service de médecine physique et de réadaptation, Hôpital Henry Gabrielle, Groupement Hospitalier Sud, HCL
city: Saint-Etienne
country: France
facility: Service de médecine physique et de réadaptation, Hôpital Bellevue, CHU Saint Etienne
Study officials:
References:
citation: Khettar S, Jacquin Courtois S, Luaute J, Decullier E, Bin S, Dupuis M, Derex L, Mechtouff L, Nighoghossian N, Dussart C, Rode G, Janoly-Dumenil A. Multiprofessional intervention to improve adherence to medication in stroke patients: a study protocol for a randomised controlled trial (ADMED AVC study). Eur J Hosp Pharm. 2022 May;29(3):169-175. doi: 10.1136/ejhpharm-2020-002425. Epub 2020 Sep 25.