- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03321058
Polymedication-Check With Insight in Patients' Medication Organisation and Comprehension of Generics
October 24, 2017 updated by: Kurt Hersberger, University Hospital, Basel, Switzerland
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
125
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Basel-Stadt
-
Basel, Basel-Stadt, Switzerland, 4056
- University of Basel
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- medication provided in Multicompartment Compliance Aid or similar device by specific service (pharmacy, elderly home, home care)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
retrospective 3 months
|
|
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.
|
retrospective 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patients using Multicompartment Compliance Aids.
Time Frame: retrospective 3 months
|
Assessment of proportion of patients already using Multicompartment Compliance Aids prior to interview.
|
retrospective 3 months
|
|
Number of substitutable medicines.
Time Frame: retrospective 3 months
|
Assessment of number of brand name medication which could be substituted by generic medication and willingness of pharmacists to recommend generic medicines.
|
retrospective 3 months
|
|
Swallowing difficulties
Time Frame: retrospective 3 months
|
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.
|
retrospective 3 months
|
|
Recommended use of Multicompartment Compliance Aids
Time Frame: retrospective 3 months
|
Number of recommended use of Multicompartment Compliance Aids by pharmacists.
|
retrospective 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Olsson 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.
- Hakonsen 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.
- Nunney 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 6, 2017
Primary Completion (ACTUAL)
October 1, 2017
Study Completion (ACTUAL)
October 24, 2017
Study Registration Dates
First Submitted
June 1, 2017
First Submitted That Met QC Criteria
October 24, 2017
First Posted (ACTUAL)
October 25, 2017
Study Record Updates
Last Update Posted (ACTUAL)
October 25, 2017
Last Update Submitted That Met QC Criteria
October 24, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- PMC-Medication-Organisation
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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