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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03321058
Other study ID # PMC-Medication-Organisation
Secondary ID
Status Completed
Phase N/A
First received June 1, 2017
Last updated October 24, 2017
Start date January 6, 2017
Est. completion date October 24, 2017

Study information

Verified date October 2017
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 pharmacies. Data will allow to better address patients' needs in their medication organisation and comprehension of generics.


Recruitment information / eligibility

Status Completed
Enrollment 125
Est. completion date October 24, 2017
Est. primary completion date October 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Assessment
Assessment of patients' medication organisation and comprehension of generics

Locations

Country Name City State
Switzerland University of Basel Basel Basel-Stadt

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland University of Basel

Country where clinical trial is conducted

Switzerland, 

References & Publications (4)

Håkonsen 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. — View Citation

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. — View Citation

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. Review. — View Citation

Olsson E, Kälvemark 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. retrospective 3 months
Primary 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. retrospective 3 months
Secondary Number of patients using Multicompartment Compliance Aids. Assessment of proportion of patients already using Multicompartment Compliance Aids prior to interview. retrospective 3 months
Secondary 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. retrospective 3 months
Secondary 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. retrospective 3 months
Secondary Recommended use of Multicompartment Compliance Aids Number of recommended use of Multicompartment Compliance Aids by pharmacists. retrospective 3 months
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