Impact of a Pluriprofessional Intervention to Improve Medication Adherence (Secondary Preventive Medication) in Patients After Ischemic Stroke
ADMED-AVC
1 other identifier
interventional
182
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2015
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 29, 2015
CompletedFirst Submitted
Initial submission to the registry
October 1, 2015
CompletedFirst Posted
Study publicly available on registry
November 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 28, 2020
CompletedDecember 20, 2019
December 1, 2019
5 years
October 1, 2015
December 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measure of patient's adherence to medication. This adherence measurement is a composite measure
A patient will be considered adherent if: 1. For each secondary-preventive drug (antiplatelet, lipid lowering, and antihypertensive), evaluated by the pharmacy refills: Number of days of medication available to the patient (supplied by the pharmacy divided by the total number of days in the period of the study (365)), is higher than 80%. 2. And score obtained from self-reported adherence questionnaire, greater than 6/8 is obtained for all secondary preventative medication
One year after inclusion
Secondary Outcomes (11)
Analysis of pharmacy refills
1 year after inclusion
Percentage of patients with drug-related iatrogenic events
1 year after inclusion
Percentage of patients with a new stroke or cardiovascular event
1 year after inclusion
Percentage of patients readmitted in hospitalization
1 year after the inclusion
Realization of a questionnaire (Likert-type scale)
1 year after inclusion
- +6 more secondary outcomes
Study Arms (2)
Pharmacist Intervention
EXPERIMENTALIt will be a semi -structured interviews with patient and pharmacist over various time after the stroke (at Month0, M3, M6, M9) combined with patient's therapeutic follow-up from various healthcare professionals.
Control
NO INTERVENTIONNo pharmacist intervention planned.
Interventions
Initial interview with pharmacist (at the hospital discharge): Evaluation aimed to identify barriers to adherence to drug treatment followed by an information session on the disease, the benefit of drugs and the importance of diet and lifestyle habits. Pharmacist advices focused on how to take medication and how to manage adverse events will be provided. Telephone interviews with hospital clinical pharmacist - patient (at M3 M6 and M9): The objective is to review with the patient its medication-taking routine and its potential difficulties, to motivate adherence to treatment and lifestyle/dietary rules, to give advices about therapeutics and how to take medication. HCP contacts CP to determine the prescription refill. Final interview with HCP pharmacist (at M12): The objective is to take stock with the patient about its taking drug load.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Service de neurologie vasculaire, Hôpital P Wertheimer, HCL
Bron, 69677, France
Service de médecine physique et de réadaptation, Hôpital Nord, CHU de Clermont Ferrand
Cébazat, 63 118, France
Service de médecine physique et de réadaptation, Hôpital sud, CHU de Grenoble
Échirolles, 38434, France
Service de médecine physique et de réadaptation, Groupe hospitalier Lariboisière - Fernand Vidal, AP-HP
Paris, 75010, France
Service de médecine physique et de réadaptation, Hôpital Bellevue, CHU Saint Etienne
Saint-Etienne, 42055, France
Service de médecine physique et de réadaptation, Hôpital Henry Gabrielle, Groupement Hospitalier Sud, HCL
Saint-Genis-Laval, 69230, France
Related Publications (1)
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.
PMID: 32978218DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2015
First Posted
November 20, 2015
Study Start
July 29, 2015
Primary Completion
July 28, 2020
Study Completion
July 28, 2020
Last Updated
December 20, 2019
Record last verified: 2019-12