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Tools to Assess Medication Adherence

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ClinicalTrials.gov Identifier: NCT04772066
Recruitment Status : Recruiting
First Posted : February 26, 2021
Last Update Posted : March 8, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

The issue of medication adherence (MA) has long been undestimated but is now growing interest due to both the increase of patients with chronic diseases and the aging of the population. According to the World Health Organization, only 50% of patients with chronic illnesses correctly follow physician's prescriptions in developed countries. Beyond the individual consequences that failure to adherence can engender (increased morbidity, mortality and hospitalizations), this concept also encompasses a collective dimension (risk of transmission of infectious diseases and increased health care costs). Today, improving MA would have more impact on human health than developping new medical therapies. That's why detecting non-adherence constitutes a major public health issue in which pharmacists play a significant role through medication reconciliation and patients' education.

The methods wildly used are based on indirect measurement: questionnaires completed by the patient himself or the Medication Possession Ratio (MPR). Each method has its own advantages and disadvantages, but none is considered as the gold standard. The Montpellier University Hospital set up a MA self-report scale ranging from 0 (low) to 10 (high adherence) in the various care units where the clinical pharmacy activity is deployed.

The purpose of this study was to assess the MA according to this numerical scale and the MPR calculation, and evaluate the correlation between these two methods.


Condition or disease Intervention/treatment
Medication Adherence Other: Measure of medication adherence

Study Design
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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Tools to Assess Medication Adherence
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Groups and Cohorts
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Group/Cohort Intervention/treatment
Non adherent patients
Non adherent patients
 Other: Measure of medication adherence
Measure of medication adherence
Adherent patients
Adherent patients
 Other: Measure of medication adherence
Measure of medication adherence


Outcome Measures
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Primary Outcome Measures :
  1. Self-reported MA according to self-reported medication adherence scale [ Time Frame: 1 day ]
    Self-reported MA according to self-reported MA scale : The self-report scale ranges from 0 (low) to 10 (high adherence)

  2. MA according to Medication Possession Ratio (MPR) calculation [ Time Frame: 1 day ]
    MA according to Medication Possession Ratio (MPR) calculation


Secondary Outcome Measures :
  1. Number of patients with medication non-adherence according to self-reported MA scale and MPR calculation [ Time Frame: 1 day ]
    Number of patients with medication non-adherence according to self-reported MA scale and MPR calculation

  2. Variables associated with medication non-adherence [ Time Frame: 1 day ]
    Variables associated with medication non-adherence


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study population was composed of patients admitted in Montpellier University Hospital.
Criteria

Inclusion criteria:

- Subjects aged over 18 years old, admitted in a care unit of Montpellier University Hospital where the clinical pharmacy activity is deployed

Exclusion criteria:

- Subjects without any medication therapy at home

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): NCT04772066


Contacts
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Contact: Cyril BREUKER, PharmD,Phd 467337121 ext 33 c-breuker@chu-montpellier.fr
Contact: Laura Lohan-Descamps, PharmD 467338562 ext 33 lohan_descamps@chu-montpellier.fr

Locations
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France
Uhmontpellier Recruiting
Montpellier, France, 34295
Contact: cyril BREUKER       c-breuker@chu-montpellier.fr   
Contact: Laura Lohan-Descamps         
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Cyril BREUKER, PharmD, PhD University Hospital, Montpellier
More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04772066    
Other Study ID Numbers: RECHMPL20_0662
First Posted: February 26, 2021    Key Record Dates
Last Update Posted: March 8, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Medication Adherence
Clinical Pharmacist
Self-reported scale