Multidrug Blister Pack Study

NCT ID: NCT01759095

Last Updated: 2015-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Typical adherence rates for oral prescription medications are approximately 50-76%. Insufficient adherence causes an increase in morbidity, mortality, and costs, and decreases quality of life of patients. Multidrug blister packs are recommended to improve adherence and are widely used in Switzerland. However, evidence is poor and patient-relevant endpoints are seldom measured. This study was designed to compare patient-relevant outcomes in patients with medication repackaged in multidrug blister packs versus patients with medication dispensed in commercially available packages. Adherence of the intervention group will be monitored electronically and feedback will be given to the patients. The intervention will take place in a study pharmacy. Follow-up visits will take place at the study pharmacy at 3, 6, and 12 months for all patients. Study duration will be 12 months.

Conditions

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Any Event Leading to Hospitalisation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Electronic Multidrug Blister Pack

Group Type EXPERIMENTAL

Electronic multidrug blister pack

Intervention Type DEVICE

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.

Interventions

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Electronic multidrug blister pack

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.

Intervention Type DEVICE

Other Intervention Names

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Multidrug blister pack: Pharmis GmbH, Beinwil am See, Switzerland Electronic film: Confrérie Clinique S.A., Lausanne, Switzerland

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kurt Hersberger

OTHER

Sponsor Role lead

Responsible Party

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Kurt Hersberger

Professor PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kurt E Hersberger, Prof PhD

Role: STUDY_CHAIR

University of Basel

Locations

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Notfallapotheke

Basel, Canton of Basel-City, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 21901694 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9467683 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16079372 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14998735 (View on PubMed)

Related Links

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http://www.pharmacare.unibas.ch

Pharmaceutical Care Research Group, University of Basel, Switzerland

Other Identifiers

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EKBB54/12

Identifier Type: -

Identifier Source: org_study_id

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