Any Event Leading to Hospitalisation Clinical Trial
Official title:
Electronic Multidrug Blister Packs to Improve Clinical and Humanistic Outcomes in Patients After Hospital Discharge
| Verified date | April 2015 |
| Source | University Hospital, Basel, Switzerland |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: Ethikkommission |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 11 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Notfallapotheke | Basel | Basel-Stadt |
| Lead Sponsor | Collaborator |
|---|---|
| Kurt Hersberger |
Switzerland,
Cramer JA. Enhancing patient compliance in the elderly. Role of packaging aids and monitoring. Drugs Aging. 1998 Jan;12(1):7-15. Review. — View Citation
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. Review. — View Citation
Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. Review. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to rehospitalisation + time to major therapy adjustment | The outcome measure will be assessed at 3, 6, and 12 months. | 12 months | No |
| Primary | Medication Possession Ratio | MPR will be assessed at 3, 6, and 12 months. | 12 months | No |
| Secondary | 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. | 12 months | No |
| Secondary | Quality of life | Quality of life will be assessed at 3, 6, and 12 months. | 12 months | No |
| Secondary | Patient satisfaction | 12 months | No |