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

December 18, 2019 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

182

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bron, France, 69677
        • Recruiting
        • Service de neurologie vasculaire, Hôpital P Wertheimer, HCL
        • Sub-Investigator:
          • Laura MECHTOUFF, MD
        • Contact:
        • Principal Investigator:
          • Norbert NIGHOGHOSSIAN, MD
        • Sub-Investigator:
          • Laurent DEREX, MD
      • Cébazat, France, 63 118
        • Recruiting
        • Service de médecine physique et de réadaptation, Hôpital Nord, CHU de Clermont Ferrand
        • Contact:
        • Principal Investigator:
          • Emmanuel COUDEYRE, MD
      • Echirolles, France, 38434
        • Recruiting
        • Service de médecine physique et de réadaptation, Hôpital sud, CHU de Grenoble
        • Contact:
        • Principal Investigator:
          • Dominique PERENNOU, MD
      • Paris, France, 75010
        • Recruiting
        • Service de médecine physique et de réadaptation, Groupe hospitalier Lariboisière - Fernand Vidal, AP-HP
        • Contact:
        • Principal Investigator:
          • Alain YELNIK, MD
        • Sub-Investigator:
          • Victorine QUINTAINE, MD
      • Saint Genis Laval, France, 69230
        • Recruiting
        • Service de médecine physique et de réadaptation, Hôpital Henry Gabrielle, Groupement Hospitalier Sud, HCL
        • Principal Investigator:
          • Gilles RODE, MD
        • Sub-Investigator:
          • Jacques LUAUTE, MD
        • Contact:
      • Saint-Etienne, France, 42055
        • Not yet recruiting
        • Service de médecine physique et de réadaptation, Hôpital Bellevue, CHU Saint Etienne
        • Principal Investigator:
          • Pascal GIRAUX, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
No Intervention: Control
No pharmacist intervention planned.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of patient's adherence to medication. This adherence measurement is a composite measure
Time Frame: One year after inclusion

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of pharmacy refills
Time Frame: 1 year after inclusion
To estimate the benefit of the intervention on the adherence for each drug, 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%.
1 year after inclusion
Percentage of patients with drug-related iatrogenic events
Time Frame: 1 year after inclusion
To estimate the benefit of the intervention on the drug-related iatrogenic events, with a particular attention on the antiplatelet, VKA and the direct oral anticoagulants drugs
1 year after inclusion
Percentage of patients with a new stroke or cardiovascular event
Time Frame: 1 year after inclusion
To estimate the benefit of the intervention on the recurrence of stroke or another cardiovascular event
1 year after inclusion
Percentage of patients readmitted in hospitalization
Time Frame: 1 year after the inclusion
To estimate the benefit of the intervention on the rehospitalization
1 year after the inclusion
Realization of a questionnaire (Likert-type scale)
Time Frame: 1 year after inclusion
To estimate the benefit of the intervention on the lifestyle risk factors
1 year after inclusion
Measure of glycemic and lipid balance.
Time Frame: 1 year after inclusion
To estimate the benefit of the intervention on laboratory tests
1 year after inclusion
Realization of a questionnaire scoring (SF-36 scale)
Time Frame: 1 year after inclusion
Estimate the benefit of the intervention on the quality of life of the patients
1 year after inclusion
Realization of a questionnaire (Brief IPQR)
Time Frame: 1 year after inclusion
Estimate the profit of the intervention on the representation of the disease for the patient
1 year after inclusion
Brief IPQR score and medication adherence (treatment adherence score and pharmacy refills) correlation (composite measure)
Time Frame: 1 year after inclusion
To measure impact of the representation of the disease on adherence to medication
1 year after inclusion
Realization of questionnaires (Likert-type scale and SATMED) assessment of satisfaction of patients
Time Frame: 1 year after inclusion
To estimate in each groups, the satisfaction of patients on their therapeutic follow-up, on their medication, and their relationship with the healthcare professionals (CP , GP , HCP, HPhys)
1 year after inclusion
Realization of a questionnaire (Likert-type scale) assessment of satisfaction of GP and CP in relation to ADMED-AVC program.
Time Frame: 1 year after inclusion
To estimate the satisfaction of general practitioners and community pharmacists concerning the ADMED-AVC's program
1 year after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2015

Primary Completion (Anticipated)

July 28, 2020

Study Completion (Anticipated)

July 28, 2020

Study Registration Dates

First Submitted

October 1, 2015

First Submitted That Met QC Criteria

November 18, 2015

First Posted (Estimate)

November 20, 2015

Study Record Updates

Last Update Posted (Actual)

December 20, 2019

Last Update Submitted That Met QC Criteria

December 18, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014.859

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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