Any Event Leading to HospitalisationNCT01759095
Multidrug Blister Pack Study
A study testing Electronic multidrug blister pack in people with Any Event Leading to Hospitalisation, run by Kurt Hersberger at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Any Event Leading to Hospitalisation
- What is being tested?
- Electronic multidrug blister pack
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electronic Multidrug Blister Packs to Improve Clinical and Humanistic Outcomes in Patients After Hospital Discharge
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.
Read the 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.
- Conditions
- Any Event Leading to Hospitalisation
- Being tested
- Electronic multidrug blister pack
- Keywords
- adherence, electronic monitoring, primary care, community pharmacy, multidrug blister pack, pill box
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic multidrug blister packDevice
Also called Multidrug blister pack: Pharmis GmbH, Beinwil am See, Switzerland, Electronic film: Confrérie Clinique S.A., Lausanne, Switzerland
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | At hospital discharge, patients of the control group will receive usual care at their community pharmacy. |
| Electronic Multidrug Blister Pack | Experimental | Not described Receives: Device: Electronic multidrug blister pack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to rehospitalisation + time to major therapy adjustment
The outcome measure will be assessed at 3, 6, and 12 months.
Measured: 12 months
Medication Possession Ratio
MPR will be assessed at 3, 6, and 12 months.
Measured: 12 months
Secondary outcomes (3)
Timing and taking adherence according to the electronic monitoring system and through patient self report
Electronic monitoring will be continuous over 12 months. Patient self report will be assessed at 3, 6, and 12 months.
Measured: 12 months
Quality of life
Quality of life will be assessed at 3, 6, and 12 months.
Measured: 12 months
Patient satisfaction
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Difficulties with patient recruitement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Any Event Leading to HospitalisationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kurt Hersberger
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kurt Hersberger, University Hospital, Basel, Switzerland
- Investigators
- Kurt E Hersberger, Prof PhD, Study chair, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759095
- Sponsor's protocol ID
- EKBB54/12
- Status last verified
- Apr 2015
- First submitted
- 2 Nov 2012
- Last updated
- 9 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21901694Cramer 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.
PubMed 9467683Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.
PubMed 16079372Rosen 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.
PubMed 14998735
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Multidrug Blister Packs to Improve Clinical and Humanistic Outcomes in Patients After Hospital Discharge
- ClinicalTrials.gov ID
- NCT01759095
- Acronym / sponsor ID
- EKBB54/12
- Conditions
- Any Event Leading to Hospitalisation
- Keywords
- adherence, electronic monitoring, primary care, community pharmacy, multidrug blister pack, pill box
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties with patient recruitement
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Kurt HersbergerUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 2 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic multidrug blister packAlso: Multidrug blister pack: Pharmis GmbH, Beinwil am See, Switzerland, Electronic film: Confrérie Clinique S.A., Lausanne, SwitzerlandAt 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. | Device | Electronic Multidrug Blister Pack |
Primary outcome
Time to rehospitalisation + time to major therapy adjustment
Time frame: 12 months
The outcome measure will be assessed at 3, 6, and 12 months.
Medication Possession Ratio
Time frame: 12 months
MPR will be assessed at 3, 6, and 12 months.
3 secondary outcomes
Timing and taking adherence according to the electronic monitoring system and through patient self report
Time frame: 12 months
Quality of life
Time frame: 12 months
Patient satisfaction
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Difficulties with patient recruitement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2015.
- Background: PubMed 21901694Mahtani 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.
- Background: PubMed 9467683Cramer 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.
- Background: PubMed 16079372Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.
- Background: PubMed 14998735Rosen 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.
- Pharmaceutical Care Research Group, University of Basel, SwitzerlandLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kurt E Hersberger, Prof PhD study chair
University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic multidrug blister pack in people with Any Event Leading to Hospitalisation, run by Kurt Hersberger at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulties with patient recruitement). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to rehospitalisation + time to major therapy adjustment (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01759095, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2015.