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

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ClinicalTrials.gov Identifier: NCT02611440
Recruitment Status : Unknown
Verified December 2019 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : November 20, 2015
Last Update Posted : December 20, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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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.


Condition or disease Intervention/treatment Phase
Ischemic Stroke Behavioral: Pharmaceutical care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of a Pluriprofessional Intervention to Improve Medication Adherence (Secondary Preventive Medication) in Patients After Ischemic Stroke (ADMED-AVC)
Actual Study Start Date : July 29, 2015
Estimated Primary Completion Date : July 28, 2020
Estimated Study Completion Date : July 28, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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%.

  2. 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

  3. 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

  4. Percentage of patients readmitted in hospitalization [ Time Frame: 1 year after the inclusion ]
    To estimate the benefit of the intervention on the rehospitalization

  5. 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

  6. Measure of glycemic and lipid balance. [ Time Frame: 1 year after inclusion ]
    To estimate the benefit of the intervention on laboratory tests

  7. 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

  8. 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

  9. 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

  10. 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)

  11. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02611440


Contacts
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Contact: Audrey JANOLY-DUMENIL, Pharmacist +33 4 721 191 82 audrey.janoly-dumenil@chu-lyon.fr
Contact: Marine DUPUIS +33 4 788 612 25 marine.dupuis01@chu-lyon.fr

Locations
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France
Service de neurologie vasculaire, Hôpital P Wertheimer, HCL Recruiting
Bron, France, 69677
Contact: Norbert NIGHOGHOSSIAN, MD    33(0)472681322    norbert.nighoghossian@chu-lyon.fr   
Principal Investigator: Norbert NIGHOGHOSSIAN, MD         
Sub-Investigator: Laurent DEREX, MD         
Sub-Investigator: Laura MECHTOUFF, MD         
Service de médecine physique et de réadaptation, Hôpital Nord, CHU de Clermont Ferrand Recruiting
Cébazat, France, 63 118
Contact: Emmanuel COUDEYRE, MD       ecoudeyre@chu-clermontferrand.fr   
Principal Investigator: Emmanuel COUDEYRE, MD         
Service de médecine physique et de réadaptation, Hôpital sud, CHU de Grenoble Recruiting
Echirolles, France, 38434
Contact: Dominique PERENNOU, MD       DPerrennou@chu-grenoble.fr   
Principal Investigator: Dominique PERENNOU, MD         
Service de médecine physique et de réadaptation, Groupe hospitalier Lariboisière - Fernand Vidal, AP-HP Recruiting
Paris, France, 75010
Contact: Alain YELNIK, MD    33(0)149956469    alain.yelnik@lrb.ap-hp.fr   
Principal Investigator: Alain YELNIK, MD         
Sub-Investigator: Victorine QUINTAINE, MD         
Service de médecine physique et de réadaptation, Hôpital Henry Gabrielle, Groupement Hospitalier Sud, HCL Recruiting
Saint Genis Laval, France, 69230
Contact: Gilles RODE, MD    33(0)478865066    gilles.rode@chu-lyon.fr   
Principal Investigator: Gilles RODE, MD         
Sub-Investigator: Sophie JACQUIN-COURTOIS, MD         
Sub-Investigator: Jacques LUAUTE, MD         
Service de médecine physique et de réadaptation, Hôpital Bellevue, CHU Saint Etienne Not yet recruiting
Saint-Etienne, France, 42055
Contact: Pascal GIRAUX, MD       pascal.giraud@univ-st-etienne.fr   
Principal Investigator: Pascal GIRAUX, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02611440    
Other Study ID Numbers: 2014.859
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019
Keywords provided by Hospices Civils de Lyon:
ischemic stroke
medication adherence
cardiovascular disease prevention
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Infarction
Necrosis