Impact of a Pluriprofessional Intervention to Improve Medication Adherence (Secondary Preventive Medication) in Patients After Ischemic Stroke (ADMED-AVC)
Primary Purpose
Ischemic Stroke
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pharmaceutical care
Sponsored by
About this trial
This is an interventional supportive care trial for Ischemic Stroke focused on measuring ischemic stroke, medication adherence, cardiovascular disease prevention
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
Sites / Locations
- Service de neurologie vasculaire, Hôpital P Wertheimer, HCLRecruiting
- Service de médecine physique et de réadaptation, Hôpital Nord, CHU de Clermont FerrandRecruiting
- Service de médecine physique et de réadaptation, Hôpital sud, CHU de GrenobleRecruiting
- Service de médecine physique et de réadaptation, Groupe hospitalier Lariboisière - Fernand Vidal, AP-HPRecruiting
- Service de médecine physique et de réadaptation, Hôpital Henry Gabrielle, Groupement Hospitalier Sud, HCLRecruiting
- Service de médecine physique et de réadaptation, Hôpital Bellevue, CHU Saint Etienne
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pharmacist Intervention
Control
Arm Description
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.
No pharmacist intervention planned.
Outcomes
Primary Outcome Measures
Measure of patient's adherence to medication. This adherence measurement is a composite measure
A patient will be considered adherent if:
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%.
And score obtained from self-reported adherence questionnaire, greater than 6/8 is obtained for all secondary preventative medication
Secondary Outcome Measures
Analysis of pharmacy refills
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%.
Percentage of patients with drug-related iatrogenic events
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
Percentage of patients with a new stroke or cardiovascular event
To estimate the benefit of the intervention on the recurrence of stroke or another cardiovascular event
Percentage of patients readmitted in hospitalization
To estimate the benefit of the intervention on the rehospitalization
Realization of a questionnaire (Likert-type scale)
To estimate the benefit of the intervention on the lifestyle risk factors
Measure of glycemic and lipid balance.
To estimate the benefit of the intervention on laboratory tests
Realization of a questionnaire scoring (SF-36 scale)
Estimate the benefit of the intervention on the quality of life of the patients
Realization of a questionnaire (Brief IPQR)
Estimate the profit of the intervention on the representation of the disease for the patient
Brief IPQR score and medication adherence (treatment adherence score and pharmacy refills) correlation (composite measure)
To measure impact of the representation of the disease on adherence to medication
Realization of questionnaires (Likert-type scale and SATMED) assessment of satisfaction of patients
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)
Realization of a questionnaire (Likert-type scale) assessment of satisfaction of GP and CP in relation to ADMED-AVC program.
To estimate the satisfaction of general practitioners and community pharmacists concerning the ADMED-AVC's program
Full Information
NCT ID
NCT02611440
First Posted
October 1, 2015
Last Updated
December 18, 2019
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT02611440
Brief Title
Impact of a Pluriprofessional Intervention to Improve Medication Adherence (Secondary Preventive Medication) in Patients After Ischemic Stroke
Acronym
ADMED-AVC
Official Title
Impact of a Pluriprofessional Intervention to Improve Medication Adherence (Secondary Preventive Medication) in Patients After Ischemic Stroke (ADMED-AVC)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 29, 2015 (Actual)
Primary Completion Date
July 28, 2020 (Anticipated)
Study Completion Date
July 28, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
ischemic stroke, medication adherence, cardiovascular disease prevention
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
182 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pharmacist Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No pharmacist intervention planned.
Intervention Type
Behavioral
Intervention Name(s)
Pharmaceutical care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measure of patient's adherence to medication. This adherence measurement is a composite measure
Description
A patient will be considered adherent if:
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%.
And score obtained from self-reported adherence questionnaire, greater than 6/8 is obtained for all secondary preventative medication
Time Frame
One year after inclusion
Secondary Outcome Measure Information:
Title
Analysis of pharmacy refills
Description
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%.
Time Frame
1 year after inclusion
Title
Percentage of patients with drug-related iatrogenic events
Description
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
Time Frame
1 year after inclusion
Title
Percentage of patients with a new stroke or cardiovascular event
Description
To estimate the benefit of the intervention on the recurrence of stroke or another cardiovascular event
Time Frame
1 year after inclusion
Title
Percentage of patients readmitted in hospitalization
Description
To estimate the benefit of the intervention on the rehospitalization
Time Frame
1 year after the inclusion
Title
Realization of a questionnaire (Likert-type scale)
Description
To estimate the benefit of the intervention on the lifestyle risk factors
Time Frame
1 year after inclusion
Title
Measure of glycemic and lipid balance.
Description
To estimate the benefit of the intervention on laboratory tests
Time Frame
1 year after inclusion
Title
Realization of a questionnaire scoring (SF-36 scale)
Description
Estimate the benefit of the intervention on the quality of life of the patients
Time Frame
1 year after inclusion
Title
Realization of a questionnaire (Brief IPQR)
Description
Estimate the profit of the intervention on the representation of the disease for the patient
Time Frame
1 year after inclusion
Title
Brief IPQR score and medication adherence (treatment adherence score and pharmacy refills) correlation (composite measure)
Description
To measure impact of the representation of the disease on adherence to medication
Time Frame
1 year after inclusion
Title
Realization of questionnaires (Likert-type scale and SATMED) assessment of satisfaction of patients
Description
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)
Time Frame
1 year after inclusion
Title
Realization of a questionnaire (Likert-type scale) assessment of satisfaction of GP and CP in relation to ADMED-AVC program.
Description
To estimate the satisfaction of general practitioners and community pharmacists concerning the ADMED-AVC's program
Time Frame
1 year after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Audrey JANOLY-DUMENIL, Pharmacist
Phone
+33 4 721 191 82
Email
audrey.janoly-dumenil@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marine DUPUIS
Phone
+33 4 788 612 25
Email
marine.dupuis01@chu-lyon.fr
Facility Information:
Facility Name
Service de neurologie vasculaire, Hôpital P Wertheimer, HCL
City
Bron
ZIP/Postal Code
69677
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Norbert NIGHOGHOSSIAN, MD
Phone
33(0)472681322
Email
norbert.nighoghossian@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Norbert NIGHOGHOSSIAN, MD
First Name & Middle Initial & Last Name & Degree
Laurent DEREX, MD
First Name & Middle Initial & Last Name & Degree
Laura MECHTOUFF, MD
Facility Name
Service de médecine physique et de réadaptation, Hôpital Nord, CHU de Clermont Ferrand
City
Cébazat
ZIP/Postal Code
63 118
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel COUDEYRE, MD
Email
ecoudeyre@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Emmanuel COUDEYRE, MD
Facility Name
Service de médecine physique et de réadaptation, Hôpital sud, CHU de Grenoble
City
Echirolles
ZIP/Postal Code
38434
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique PERENNOU, MD
Email
DPerrennou@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Dominique PERENNOU, MD
Facility Name
Service de médecine physique et de réadaptation, Groupe hospitalier Lariboisière - Fernand Vidal, AP-HP
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alain YELNIK, MD
Phone
33(0)149956469
Email
alain.yelnik@lrb.ap-hp.fr
First Name & Middle Initial & Last Name & Degree
Alain YELNIK, MD
First Name & Middle Initial & Last Name & Degree
Victorine QUINTAINE, MD
Facility Name
Service de médecine physique et de réadaptation, Hôpital Henry Gabrielle, Groupement Hospitalier Sud, HCL
City
Saint Genis Laval
ZIP/Postal Code
69230
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles RODE, MD
Phone
33(0)478865066
Email
gilles.rode@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Gilles RODE, MD
First Name & Middle Initial & Last Name & Degree
Sophie JACQUIN-COURTOIS, MD
First Name & Middle Initial & Last Name & Degree
Jacques LUAUTE, MD
Facility Name
Service de médecine physique et de réadaptation, Hôpital Bellevue, CHU Saint Etienne
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal GIRAUX, MD
Email
pascal.giraud@univ-st-etienne.fr
First Name & Middle Initial & Last Name & Degree
Pascal GIRAUX, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
32978218
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.
Results Reference
derived
Learn more about this trial
Impact of a Pluriprofessional Intervention to Improve Medication Adherence (Secondary Preventive Medication) in Patients After Ischemic Stroke
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