NCT01759095

Brief Summary

The purpose of this study is to determine the benefit of patients using a multidrug blister packs after discharged from an university hospital to their homes.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

November 2, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 2, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 9, 2015

Status Verified

April 1, 2015

Enrollment Period

1.9 years

First QC Date

November 2, 2012

Last Update Submit

April 8, 2015

Conditions

Any Event Leading to Hospitalisation

Keywords

adherenceelectronic monitoringprimary carecommunity pharmacymultidrug blister packpill box

Outcome Measures

Primary Outcomes (2)

  • Time to rehospitalisation + time to major therapy adjustment

    The outcome measure will be assessed at 3, 6, and 12 months.

    12 months

  • Medication Possession Ratio

    MPR will be assessed at 3, 6, and 12 months.

    12 months

Secondary Outcomes (3)

  • Timing and taking adherence according to the electronic monitoring system and through patient self report

    12 months

  • Quality of life

    12 months

  • Patient satisfaction

    12 months

Study Arms (2)

Control

NO INTERVENTION

At hospital discharge, patients of the control group will receive usual care at their community pharmacy.

Electronic Multidrug Blister Pack

EXPERIMENTAL
Device: Electronic multidrug blister pack

Interventions

Electronic multidrug blister packDEVICE

At hospital discharge, patients will get their prescribed drugs repackaged in an electronic multidrug blister pack with 7x4 cavities. The electronic film affixed on the rear side measures the date and time when a loop is broken, i.e. when a cavity is emptied. Patients will get feedback on their adherence profiles at the community pharmacy.

Also known as: Multidrug blister pack: Pharmis GmbH, Beinwil am See, Switzerland, Electronic film: Confrérie Clinique S.A., Lausanne, Switzerland
Electronic Multidrug Blister Pack

Eligibility Criteria

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

You may qualify if:

  • Age over 18 years
  • Prescription of 4 or more different oral solid drugs
  • Capable to understand german (verbally and written)
  • Capable to give informed consent
  • Insured by a Swiss health insurance
  • Manages his/her pharmacotherapy without external support
  • Obtains his/her medication from a community pharmacy
  • Accepts to use an electronic multidrug blister pack
  • Place of domicile in Basel-Stadt or Basel-Land

You may not qualify if:

  • Pregnancy
  • \> 2 drugs that cannot be packed into a multidrug blister pack (e.g. fluids)
  • Dementia, or evaluated as cognitively impaired by the responsible nurse
  • Transplanted patient
  • Anticoagulation with oral vitamin K antagonists
  • Has already used a multidrug blister pack of Pharmis or a Medifilm® single dose system
  • is visually impaired (blind)
  • cannot push drugs through a blister
  • refuses to allow contact to his/her regular pharmacy and GP
  • is referred to a nursing home or to rehabilitation or another hospital at discharge
  • is included in other clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Notfallapotheke

Basel, Canton of Basel-City, 4056, Switzerland

Location

Related Publications (4)

  • Mahtani KR, Heneghan CJ, Glasziou PP, Perera R. Reminder packaging for improving adherence to self-administered long-term medications. Cochrane Database Syst Rev. 2011 Sep 7;(9):CD005025. doi: 10.1002/14651858.CD005025.pub3.

    PMID: 21901694BACKGROUND

  • Cramer JA. Enhancing patient compliance in the elderly. Role of packaging aids and monitoring. Drugs Aging. 1998 Jan;12(1):7-15. doi: 10.2165/00002512-199812010-00002.

    PMID: 9467683BACKGROUND

  • Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.

    PMID: 16079372BACKGROUND

  • Rosen MI, Rigsby MO, Salahi JT, Ryan CE, Cramer JA. Electronic monitoring and counseling to improve medication adherence. Behav Res Ther. 2004 Apr;42(4):409-22. doi: 10.1016/S0005-7967(03)00149-9.

    PMID: 14998735BACKGROUND

Related Links

Study Officials

  • Kurt E Hersberger, Prof PhD

    University of Basel

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor PhD

Study Record Dates

First Submitted

November 2, 2012

First Posted

January 2, 2013

Study Start

January 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 9, 2015

Record last verified: 2015-04

Locations

CH(1)