NCT03321058

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2017

Completed
Last Updated

October 25, 2017

Status Verified

October 1, 2017

Enrollment Period

9 months

First QC Date

June 1, 2017

Last Update Submit

October 24, 2017

Conditions

Keywords

Drug SubstitutionMulticompartment Compliance Aid

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Number of patients using Multicompartment Compliance Aids.

    retrospective 3 months

  • Number of substitutable medicines.

    retrospective 3 months

  • Swallowing difficulties

    retrospective 3 months

  • Recommended use of Multicompartment Compliance Aids

    retrospective 3 months

Interventions

AssessmentBEHAVIORAL

Assessment of patients' medication organisation and comprehension of generics

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Basel

Basel, Canton of Basel-City, 4056, Switzerland

Location

Related Publications (4)

  • 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.

    PMID: 27108410BACKGROUND
  • 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.

    PMID: 23134096BACKGROUND
  • 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.

    PMID: 19708764BACKGROUND
  • 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.

    PMID: 21542662BACKGROUND

MeSH Terms

Conditions

Medication Adherence

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

June 1, 2017

First Posted

October 25, 2017

Study Start

January 6, 2017

Primary Completion

October 1, 2017

Study Completion

October 24, 2017

Last Updated

October 25, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations