Medication Therapy ManagementNCT03321058
Polymedication-Check With Insight in Patients' Medication Organisation and Comprehension of Generics
An observational study of Medication Therapy Management and Medication Adherence, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Patients using multiple drugs including generics have found different solutions to manage their medication. During a Polymedication-Check (medication review type 2a service in community pharmacies) additional information about the organisation of patients' medication in daily life will be compiled in Swiss community… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Therapy Management, Medication Adherence
- What is being tested?
- Assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 125 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Jan 2017to 24 Oct 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population comprises adults (18 years and older) with at least 4 prescribed medicines which they are taking for at least 3 months. One of those medicines must be a generic drug, one must be prescribed for a cardiovascular condition (ATC C01-10). Patients cannot have their medication provided in a Multicompartment Compliance Aid or a similar device by a specific service like home care, pharmacy or home for elderly.
Who may be able to join
- at least 4 medicines for at least 3 months
- at least 1 generic drug
- at least 1 medicine of ATC code cardiovascular system (C01-10)
Who cannot join
- medication provided in Multicompartment Compliance Aid or similar device by specific service (pharmacy, elderly home, home care)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Polymedikations-Check Und Medikamenten-Organisation im Alltag
Patients using multiple drugs including generics have found different solutions to manage their medication. During a Polymedication-Check (medication review type 2a service in community pharmacies) additional information about the organisation of patients' medication in daily life will be compiled in Swiss community pharmacies. Data will allow to better address patients' needs in their medication organisation and comprehension of generics.
- Being tested
- Assessment
- Keywords
- Drug Substitution, Multicompartment Compliance Aid
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentBehavioural
Assessment of patients' medication organisation and comprehension of generics
What is being measured
The primary outcome is the main question the study is designed to answer.
Insight in patients' organisation of polymedication
Patients organise their multiple medications differently in daily life. The study will investigate the different organisation strategies to get a better understanding of patients' behaviour. The behaviour is assessed with a questionnaire containing 14 questions on the management of medication including single choice, multiple choice and free text questions. As example the number of patients already using a medication organisation system will be assessed, the number of patients using a weekly or daily pillbox will be assessed, and who is filling the medication organisation system.
Measured: retrospective 3 months
Insight in patients' comprehension of generics
Patients have a different comprehension of generics including their advantages and disadvantages. The study will investigate patients' comprehension of generics to get a better understanding of patients' behaviour. The comprehension is assessed with a questionnaire containing 4 questions on the believes about generics including single choice, multiple choice and free text questions. As example the number of patients knowing that they use generics is assessed and the patient's personal opinion on advantages and disadvantages of generics is investigated.
Measured: retrospective 3 months
Secondary outcomes (4)
Number of patients using Multicompartment Compliance Aids.
Assessment of proportion of patients already using Multicompartment Compliance Aids prior to interview.
Measured: retrospective 3 months
Number of substitutable medicines.
Assessment of number of brand name medication which could be substituted by generic medication and willingness of pharmacists to recommend generic medicines.
Measured: retrospective 3 months
Swallowing difficulties
Prevalence of present and/or past swallowing difficulties and coping strategies will be assessed. A specific question (from SWAMECO) on the experienced swallowing difficulties is asked and will be answered on a visual analog scale (0 to 100%). If swallowing-difficulties are present, 2 more questions are asked: Which medication is difficult to swallow and how medication is altered in order to be able to swallow them.
Measured: retrospective 3 months
Recommended use of Multicompartment Compliance Aids
Number of recommended use of Multicompartment Compliance Aids by pharmacists.
Measured: retrospective 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start6 Jan 2017
- Primary completion1 Oct 2017
- Study completion24 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Medication Therapy ManagementStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Basel
- Responsible party
- Principal investigator, Kurt Hersberger, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321058
- Sponsor's protocol ID
- PMC-Medication-Organisation
- Status last verified
- Oct 2017
- First submitted
- 1 Jun 2017
- Last updated
- 25 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Messerli M, Blozik E, Vriends N, Hersberger KE. Impact of a community pharmacist-led medication review on medicines use in patients on polypharmacy--a prospective randomised controlled trial. BMC Health Serv Res. 2016 Apr 23;16:145. doi: 10.1186/s12913-016-1384-8.
PubMed 27108410Olsson E, Kalvemark Sporrong S. Pharmacists' experiences and attitudes regarding generic drugs and generic substitution: two sides of the coin. Int J Pharm Pract. 2012 Dec;20(6):377-83. doi: 10.1111/j.2042-7174.2012.00214.x. Epub 2012 Jun 1.
PubMed 23134096Hakonsen H, Eilertsen M, Borge H, Toverud EL. Generic substitution: additional challenge for adherence in hypertensive patients? Curr Med Res Opin. 2009 Oct;25(10):2515-21. doi: 10.1185/03007990903192223.
PubMed 19708764Nunney J, Raynor DK, Knapp P, Closs SJ. How do the attitudes and beliefs of older people and healthcare professionals impact on the use of multi-compartment compliance aids?: a qualitative study using grounded theory. Drugs Aging. 2011 May 1;28(5):403-14. doi: 10.2165/11587180-000000000-00000.
PubMed 21542662
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polymedikations-Check Und Medikamenten-Organisation im Alltag
- ClinicalTrials.gov ID
- NCT03321058
- Acronym / sponsor ID
- PMC-Medication-Organisation
- Keywords
- Drug Substitution, Multicompartment Compliance Aid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University of Basel
- Study start
- 6 Jan 2017 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 24 Oct 2017 (actual)
- First posted
- 25 Oct 2017 (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.
Patients using multiple drugs including generics have found different solutions to manage their medication. During a Polymedication-Check (medication review type 2a service in community pharmacies) additional information about the organisation of patients' medication in daily life will be compiled in Swiss community pharmacies. Data will allow to better address patients' needs in their medication organisation and comprehension of generics.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises adults (18 years and older) with at least 4 prescribed medicines which they are taking for at least 3 months. One of those medicines must be a generic drug, one must be prescribed for a cardiovascular condition (ATC C01-10). Patients cannot have their medication provided in a Multicompartment Compliance Aid or a similar device by a specific service like home care, pharmacy or home for elderly.
Key inclusion criteria (3 listed)
- at least 4 medicines for at least 3 months
- at least 1 generic drug
- at least 1 medicine of ATC code cardiovascular system (C01-10)
Key exclusion criteria (1 listed)
- medication provided in Multicompartment Compliance Aid or similar device by specific service (pharmacy, elderly home, home care)
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 |
|---|---|---|
| AssessmentAssessment of patients' medication organisation and comprehension of generics | Behavioural | – |
Primary outcome
Insight in patients' organisation of polymedication
Time frame: retrospective 3 months
Patients organise their multiple medications differently in daily life. The study will investigate the different organisation strategies to get a better understanding of patients' behaviour. The behaviour is assessed with a questionnaire containing 14 questions on the management of medication including single choice, multiple choice and free text questions. As example the number of patients already using a medication organisation system will be assessed, the number of patients using a weekly or daily pillbox will be assessed, and who is filling the medication organisation system.
Insight in patients' comprehension of generics
Time frame: retrospective 3 months
Patients have a different comprehension of generics including their advantages and disadvantages. The study will investigate patients' comprehension of generics to get a better understanding of patients' behaviour. The comprehension is assessed with a questionnaire containing 4 questions on the believes about generics including single choice, multiple choice and free text questions. As example the number of patients knowing that they use generics is assessed and the patient's personal opinion on advantages and disadvantages of generics is investigated.
4 secondary outcomes
Number of patients using Multicompartment Compliance Aids.
Time frame: retrospective 3 months
Number of substitutable medicines.
Time frame: retrospective 3 months
Swallowing difficulties
Time frame: retrospective 3 months
Recommended use of Multicompartment Compliance Aids
Time frame: retrospective 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
- Background: PubMed 27108410Messerli M, Blozik E, Vriends N, Hersberger KE. Impact of a community pharmacist-led medication review on medicines use in patients on polypharmacy--a prospective randomised controlled trial. BMC Health Serv Res. 2016 Apr 23;16:145. doi: 10.1186/s12913-016-1384-8.
- Background: PubMed 23134096Olsson E, Kalvemark Sporrong S. Pharmacists' experiences and attitudes regarding generic drugs and generic substitution: two sides of the coin. Int J Pharm Pract. 2012 Dec;20(6):377-83. doi: 10.1111/j.2042-7174.2012.00214.x. Epub 2012 Jun 1.
- Background: PubMed 19708764Hakonsen H, Eilertsen M, Borge H, Toverud EL. Generic substitution: additional challenge for adherence in hypertensive patients? Curr Med Res Opin. 2009 Oct;25(10):2515-21. doi: 10.1185/03007990903192223.
- Background: PubMed 21542662Nunney J, Raynor DK, Knapp P, Closs SJ. How do the attitudes and beliefs of older people and healthcare professionals impact on the use of multi-compartment compliance aids?: a qualitative study using grounded theory. Drugs Aging. 2011 May 1;28(5):403-14. doi: 10.2165/11587180-000000000-00000.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Therapy Management and Medication Adherence, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 3 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: finished, as of the sponsor's last update on 25 Oct 2017. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insight in patients' organisation of polymedication (time frame: retrospective 3 months). 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?
On the ClinicalTrials.gov record for NCT03321058, which also lists 4 linked publications.
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 25 Oct 2017.