Medication AdherenceNCT04772066
Tools to Assess Medication Adherence
An observational study of Medication Adherence, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Medication Adherence
- What is being tested?
- Measure of medication adherence
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2019to 30 Dec 2021
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population was composed of patients admitted in Montpellier University Hospital.
Who may be able to join
- Subjects aged over 18 years old, admitted in a care unit of Montpellier University Hospital where the clinical pharmacy activity is deployed
Who cannot join
- Subjects without any medication therapy at home
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
cyril BREUKER, c-breuker@chu-montpellier.fr
Laura Lohan-Descamps
About this study
Official title: Evaluation of Tools to Assess Medication Adherence
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.
- Conditions
- Medication Adherence
- Being tested
- Measure of medication adherence
- Keywords
- Medication Adherence, Clinical Pharmacist, Self-reported scale
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure of medication adherenceOther
Measure of medication adherence
| Study group | Role | What they receive |
|---|---|---|
| Non adherent patients | Non adherent patients Receives: Other: Measure of medication adherence | |
| Adherent patients | Adherent patients Receives: Other: Measure of medication adherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 day
MA according to Medication Possession Ratio (MPR) calculation
MA according to Medication Possession Ratio (MPR) calculation
Measured: 1 day
Secondary outcomes (2)
Number of patients with medication non-adherence according to self-reported MA scale and MPR calculation
Number of patients with medication non-adherence according to self-reported MA scale and MPR calculation
Measured: 1 day
Variables associated with medication non-adherence
Variables associated with medication non-adherence
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start1 Nov 2019
- Primary completion1 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cyril BREUKER, PharmD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772066
- Sponsor's protocol ID
- RECHMPL20_0662
- Status last verified
- Feb 2021
- First submitted
- 23 Feb 2021
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tools to Assess Medication Adherence
- ClinicalTrials.gov ID
- NCT04772066
- Acronym / sponsor ID
- RECHMPL20_0662
- Conditions
- Medication Adherence
- Keywords
- Medication Adherence, Clinical Pharmacist, Self-reported scale
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 26 Feb 2021 (actual)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non adherent patients | – | Other: Measure of medication adherenceNon adherent patients |
| Adherent patients | – | Other: Measure of medication adherenceAdherent patients |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population was composed of patients admitted in Montpellier University Hospital.
Key inclusion criteria (1 listed)
- Subjects aged over 18 years old, admitted in a care unit of Montpellier University Hospital where the clinical pharmacy activity is deployed
Key exclusion criteria (1 listed)
- Subjects without any medication therapy at home
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 |
|---|---|---|
| Measure of medication adherenceMeasure of medication adherence | Other | Adherent patients, Non adherent patients |
Primary outcome
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)
MA according to Medication Possession Ratio (MPR) calculation
Time frame: 1 day
MA according to Medication Possession Ratio (MPR) calculation
2 secondary outcomes
Number of patients with medication non-adherence according to self-reported MA scale and MPR calculation
Time frame: 1 day
Variables associated with medication non-adherence
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Individual participant dataSharing planned: Undecided. NC
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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.
Cyril BREUKER, PharmD, PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medication Adherence, run by University Hospital, Montpellier at 1 site 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 1 inclusion and 1 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 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Cyril BREUKER, PharmD,Phd (467337121 ext. 33, c-breuker@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported MA according to self-reported medication adherence scale (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Mar 2021.