Impact of a Pluriprofessional Intervention to Improve Medication Adherence (Secondary Preventive Medication) in Patients After Ischemic Stroke

NCT ID: NCT02611440

Last Updated: 2019-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-29

Study Completion Date

2020-07-28

Brief Summary

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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.

Detailed Description

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Conditions

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Ischemic Stroke

Keywords

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ischemic stroke medication adherence cardiovascular disease prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Pharmacist Intervention

It 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.

Group Type EXPERIMENTAL

Pharmaceutical care

Intervention Type BEHAVIORAL

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.

Control

No pharmacist intervention planned.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pharmaceutical care

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service de neurologie vasculaire, Hôpital P Wertheimer, HCL

Bron, , France

Site Status RECRUITING

Service de médecine physique et de réadaptation, Hôpital Nord, CHU de Clermont Ferrand

Cébazat, , France

Site Status RECRUITING

Service de médecine physique et de réadaptation, Hôpital sud, CHU de Grenoble

Échirolles, , France

Site Status RECRUITING

Service de médecine physique et de réadaptation, Groupe hospitalier Lariboisière - Fernand Vidal, AP-HP

Paris, , France

Site Status RECRUITING

Service de médecine physique et de réadaptation, Hôpital Bellevue, CHU Saint Etienne

Saint-Etienne, , France

Site Status NOT_YET_RECRUITING

Service de médecine physique et de réadaptation, Hôpital Henry Gabrielle, Groupement Hospitalier Sud, HCL

Saint-Genis-Laval, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Audrey JANOLY-DUMENIL, Pharmacist

Role: CONTACT

Phone: +33 4 721 191 82

Email: [email protected]

Marine DUPUIS

Role: CONTACT

Phone: +33 4 788 612 25

Email: [email protected]

Facility Contacts

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Norbert NIGHOGHOSSIAN, MD

Role: primary

Emmanuel COUDEYRE, MD

Role: primary

Dominique PERENNOU, MD

Role: primary

Alain YELNIK, MD

Role: primary

Pascal GIRAUX, MD

Role: primary

Gilles RODE, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 32978218 (View on PubMed)

Other Identifiers

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2014.859

Identifier Type: -

Identifier Source: org_study_id