NCT04772066

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

March 8, 2021

Status Verified

February 1, 2021

Enrollment Period

2.1 years

First QC Date

February 23, 2021

Last Update Submit

March 5, 2021

Conditions

Medication Adherence

Keywords

Medication AdherenceClinical PharmacistSelf-reported scale

Outcome Measures

Primary Outcomes (2)

  • Self-reported MA according to self-reported medication adherence scale

    Self-reported MA according to self-reported MA scale : The self-report scale ranges from 0 (low) to 10 (high adherence)

    1 day

  • MA according to Medication Possession Ratio (MPR) calculation

    MA according to Medication Possession Ratio (MPR) calculation

    1 day

Secondary Outcomes (2)

  • Number of patients with medication non-adherence according to self-reported MA scale and MPR calculation

    1 day

  • Variables associated with medication non-adherence

    1 day

Study Arms (2)

Non adherent patients

Non adherent patients

Other: Measure of medication adherence

Adherent patients

Adherent patients

Other: Measure of medication adherence

Interventions

Measure of medication adherenceOTHER

Measure of medication adherence

Adherent patientsNon adherent patients

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population was composed of patients admitted in Montpellier University Hospital.

You may qualify if:

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

You may not qualify if:

  • \- Subjects without any medication therapy at home

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Cyril BREUKER, PharmD, PhD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cyril BREUKER, PharmD,Phd

CONTACT

467337121c-breuker@chu-montpellier.fr

Laura Lohan-Descamps, PharmD

CONTACT

467338562lohan_descamps@chu-montpellier.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2021

First Posted

February 26, 2021

Study Start

November 1, 2019

Primary Completion

December 1, 2021

Study Completion

December 30, 2021

Last Updated

March 8, 2021

Record last verified: 2021-02

Locations

FR(1)