Multidrug Blister Pack Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01759095
Recruitment Status : Terminated (Difficulties with patient recruitement)
First Posted : January 2, 2013
Last Update Posted : April 9, 2015
Information provided by (Responsible Party):
Kurt Hersberger, University Hospital, Basel, Switzerland

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.

Condition or disease Intervention/treatment
Any Event Leading to Hospitalisation Device: Electronic multidrug blister pack

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Electronic Multidrug Blister Packs to Improve Clinical and Humanistic Outcomes in Patients After Hospital Discharge
Study Start Date : January 2013
Primary Completion Date : December 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Control
At hospital discharge, patients of the control group will receive usual care at their community pharmacy.
Experimental: Electronic Multidrug Blister Pack Device: 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.
Other Names:
  • Multidrug blister pack: Pharmis GmbH, Beinwil am See, Switzerland
  • Electronic film: Confrérie Clinique S.A., Lausanne, Switzerland

Primary Outcome Measures :
  1. Time to rehospitalisation + time to major therapy adjustment [ Time Frame: 12 months ]
    The outcome measure will be assessed at 3, 6, and 12 months.

  2. Medication Possession Ratio [ Time Frame: 12 months ]
    MPR will be assessed at 3, 6, and 12 months.

Secondary Outcome Measures :
  1. Timing and taking adherence according to the electronic monitoring system and through patient self report [ Time Frame: 12 months ]
    Electronic monitoring will be continuous over 12 months. Patient self report will be assessed at 3, 6, and 12 months.

  2. Quality of life [ Time Frame: 12 months ]
    Quality of life will be assessed at 3, 6, and 12 months.

  3. Patient satisfaction [ Time Frame: 12 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01759095

Basel, Basel-Stadt, Switzerland, 4056
Sponsors and Collaborators
Kurt Hersberger
Study Chair: Kurt E Hersberger, Prof PhD University of Basel

Additional Information:
Responsible Party: Kurt Hersberger, Professor PhD, University Hospital, Basel, Switzerland Identifier: NCT01759095     History of Changes
Other Study ID Numbers: EKBB54/12
First Posted: January 2, 2013    Key Record Dates
Last Update Posted: April 9, 2015
Last Verified: April 2015

Keywords provided by Kurt Hersberger, University Hospital, Basel, Switzerland:
electronic monitoring
primary care
community pharmacy
multidrug blister pack
pill box

Additional relevant MeSH terms:
Skin Diseases, Vesiculobullous
Skin Diseases
Pathological Conditions, Anatomical