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CompletedNCT03321058Updated Oct 25, 2017

Polymedication-Check With Insight in Patients' Medication Organisation and Comprehension of Generics

An observational study in Medication Therapy Management and Medication Adherence, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-25.

Sponsored by University Hospital, Basel, Switzerland · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
125
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Medication Therapy Management
  • Medication Adherence

Keywords

  • Drug Substitution
  • Multicompartment Compliance Aid
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  • medication provided in Multicompartment Compliance Aid or similar device by specific service (pharmacy, elderly home, home care)
04

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
125 participants (actual)
Patient registry
No

Interventions

  • BehavioralAssessment

    Assessment of patients' medication organisation and comprehension of generics

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: retrospective 3 months

  2. 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.

    Time frame: retrospective 3 months

Secondary outcomes

  1. Number of patients using Multicompartment Compliance Aids.

    Assessment of proportion of patients already using Multicompartment Compliance Aids prior to interview.

    Time frame: retrospective 3 months

  2. 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.

    Time frame: retrospective 3 months

  3. 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.

    Time frame: retrospective 3 months

  4. Recommended use of Multicompartment Compliance Aids

    Number of recommended use of Multicompartment Compliance Aids by pharmacists.

    Time frame: retrospective 3 months

06

Study locations

1 site
  • University of Basel
    Basel, Basel-Stadt 4056, Switzerland
07

References and documents

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 27108410 ↗
  • 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. PubMed 23134096 ↗
  • 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. PubMed 19708764 ↗
  • 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. PubMed 21542662 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03321058
Lead sponsor
University Hospital, Basel, Switzerland
Collaborators
University of Basel
Responsible party
Kurt Hersberger (Prof. Dr., University Hospital, Basel, Switzerland) — Principal investigator
First posted
Oct 25, 2017
Start date
Jan 6, 2017
Primary completion
Oct 1, 2017
Completion
Oct 24, 2017
Last update
Oct 25, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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