Clinical trial NCT02701660: Adherence to Polypharmacy in Patients With Opioid Substitution Therapy Using Electronics
Official title: Remote-controlled Dispensing of Medication and Electronic Monitoring of Adherence in Ambulatory Patients With Opioid Dependency Syndrome and Polypharmacy - a Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance-Related Disorders
Keywords: Pharmaceutical Care
Adherence
Polypharmacy
e-Health
opioid substitution therapy
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: University of Basel
name: Psychiatric Hospital of the University of Basel
First posted: 2016-03-08
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Electronic dispensers for polypharmacy are used in home care to assist patients with their medication management and to improve adherence. Opioid dependent patients with substitution therapy often exhibit multiple risk factors for non-adherence. The increase of both the age and associated comorbidities in this population demand for innovative solutions to optimize medication management. The investigators developed a novel medication supply model with an automated electronic medication dispenser to simultaneously assist opioid dependent patients with their medication and objectively monitor their adherence. This study aims to demonstrate the feasibility of the new supply model.


Eligibility criteria: Inclusion Criteria:

* written informed consent given
* reading and writing skills in German
* Stable housing situation in the canton of Basel-City and adjacent communities
* Accessibility by phone
* Minimum duration in opioid substitution treatment for 2 months
* Polypharmacy (\> 3 solid oral medications)
* Routine monitoring of clinical parameters less than 1 week before inclusion or agreed within 1 week from inclusion
* Insured with Swiss health insurance

Exclusion Criteria:

* opioid substitution treatment with Diacetylmorphine
* \> 2 drugs, which can not be packaged in pouches (eg liquids)

Primary outcomes:
measure: Taking Adherence (Number of days with correctly dispensed pouches (%)
timeFrame: continuous, up to 24 weeks
Secondary outcomes:
measure: Timing adherence (number of correctly dispensed pouches within predefined time-frame (%)
timeFrame: continuous, up to 24 weeks
measure: Patients' specific routine parameters according to condition(s) of participant (composite outcome)
timeFrame: up to 24 weeks
measure: Psychological distress
timeFrame: inclusion, week 12, 24, 36
measure: Quality of Life
timeFrame: inclusion, weeks 3, 6, 9, 12, 15, 18, 21, 24, 36
measure: Satisfaction
timeFrame: week 12, 24, 36
measure: Instrumental Activities of Daily Living
timeFrame: inclusion, week 12, 24, 36
measure: Cognitive Impairment
timeFrame: inclusion, week 12, 24, 36
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Outpatient addiction service, University Psychiatric Clinics
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Kurt Hersberger, Prof. MD
role: STUDY_CHAIR
References: