Ischemic StrokeADMED-AVCNCT02611440
Impact of a Pluriprofessional Intervention to Improve Medication Adherence (Secondary Preventive Medication) in Patients After Ischemic Stroke
A study testing Pharmaceutical care in people with Ischemic Stroke, run by Hospices Civils de Lyon at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Pharmaceutical care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 6 sitesFrance
- Study dates
- 29 Jul 2015to 28 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
Service de neurologie vasculaire, Hôpital P Wertheimer, HCL
Bron, 69677
Norbert NIGHOGHOSSIAN, MD, 33(0)472681322, norbert.nighoghossian@chu-lyon.fr
Norbert NIGHOGHOSSIAN, MD
- Recruiting
Service de médecine physique et de réadaptation, Hôpital Nord, CHU de Clermont Ferrand
Cébazat, 63 118
Emmanuel COUDEYRE, MD, ecoudeyre@chu-clermontferrand.fr
Emmanuel COUDEYRE, MD
- Recruiting
Service de médecine physique et de réadaptation, Hôpital sud, CHU de Grenoble
Échirolles, 38434
Dominique PERENNOU, MD, DPerrennou@chu-grenoble.fr
Dominique PERENNOU, MD
- Recruiting
Service de médecine physique et de réadaptation, Groupe hospitalier Lariboisière - Fernand Vidal, AP-HP
Paris, 75010
Alain YELNIK, MD, 33(0)149956469, alain.yelnik@lrb.ap-hp.fr
Alain YELNIK, MD
- Not yet recruiting
Service de médecine physique et de réadaptation, Hôpital Bellevue, CHU Saint Etienne
Saint-Etienne, 42055
Pascal GIRAUX, MD, pascal.giraud@univ-st-etienne.fr
Pascal GIRAUX, MD
- Recruiting
Service de médecine physique et de réadaptation, Hôpital Henry Gabrielle, Groupement Hospitalier Sud, HCL
Saint-Genis-Laval, 69230
Gilles RODE, MD, 33(0)478865066, gilles.rode@chu-lyon.fr
Gilles RODE, MD
About this study
Official title: 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.
Read more
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.
- Conditions
- Ischemic Stroke
- Being tested
- Pharmaceutical care
- Keywords
- ischemic stroke, medication adherence, cardiovascular disease prevention
- Medical subject headings
- Ischemic Stroke, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaceutical careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist Intervention | Experimental | 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. Receives: Behavioral: Pharmaceutical care |
| Control | No intervention | No pharmacist intervention planned. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One year after inclusion
Secondary outcomes (11)
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%.
Measured: 1 year after inclusion
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
Measured: 1 year after inclusion
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
Measured: 1 year after inclusion
Percentage of patients readmitted in hospitalization
To estimate the benefit of the intervention on the rehospitalization
Measured: 1 year after the inclusion
Realization of a questionnaire (Likert-type scale)
To estimate the benefit of the intervention on the lifestyle risk factors
Measured: 1 year after inclusion
Measure of glycemic and lipid balance.
To estimate the benefit of the intervention on laboratory tests
Measured: 1 year after inclusion
Realization of a questionnaire scoring (SF-36 scale)
Estimate the benefit of the intervention on the quality of life of the patients
Measured: 1 year after inclusion
Realization of a questionnaire (Brief IPQR)
Estimate the profit of the intervention on the representation of the disease for the patient
Measured: 1 year after inclusion
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
Measured: 1 year after inclusion
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)
Measured: 1 year after inclusion
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
Measured: 1 year after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study start29 Jul 2015
- Primary completion28 Jul 2020 (estimated)
- Study completion28 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02611440
- Sponsor's protocol ID
- 2014.859
- Acronym
- ADMED-AVC
- Status last verified
- Dec 2019
- First submitted
- 1 Oct 2015
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32978218
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Pluriprofessional Intervention to Improve Medication Adherence (Secondary Preventive Medication) in Patients After Ischemic Stroke (ADMED-AVC)
- ClinicalTrials.gov ID
- NCT02611440
- Acronym / sponsor ID
- ADMED-AVC / 2014.859
- Conditions
- Ischemic Stroke
- Keywords
- ischemic stroke, medication adherence, cardiovascular disease prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 29 Jul 2015 (actual)
- Primary completion
- 28 Jul 2020 (estimated)
- Study completion
- 28 Jul 2020 (estimated)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacist Intervention | Experimental | Behavioral: Pharmaceutical careIt 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 intervention | –No pharmacist intervention planned. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmaceutical careInitial 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. | Behavioural | Pharmacist Intervention |
Primary outcome
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
11 secondary outcomes
Analysis of pharmacy refills
Time frame: 1 year after inclusion
Percentage of patients with drug-related iatrogenic events
Time frame: 1 year after inclusion
Percentage of patients with a new stroke or cardiovascular event
Time frame: 1 year after inclusion
Percentage of patients readmitted in hospitalization
Time frame: 1 year after the inclusion
Realization of a questionnaire (Likert-type scale)
Time frame: 1 year after inclusion
Measure of glycemic and lipid balance.
Time frame: 1 year after inclusion
Realization of a questionnaire scoring (SF-36 scale)
Time frame: 1 year after inclusion
Realization of a questionnaire (Brief IPQR)
Time frame: 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
Realization of questionnaires (Likert-type scale and SATMED) assessment of satisfaction of patients
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
- Derived from this study: PubMed 32978218Khettar 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.
Related trials for Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmaceutical care in people with Ischemic Stroke, run by Hospices Civils de Lyon at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Audrey JANOLY-DUMENIL, Pharmacist (+33 4 721 191 82, audrey.janoly-dumenil@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of patient's adherence to medication. This adherence measurement is a composite measure (time frame: One year after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02611440, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2019.