Adherence to Polypharmacy in Patients With Opioid Substitution Therapy Using Electronics

Substance-Related Disorders Clinical Trial

— APPOSTEL  

Official title:

Remote-controlled Dispensing of Medication and Electronic Monitoring of Adherence in Ambulatory Patients With Opioid Dependency Syndrome and Polypharmacy - a Feasibility Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02701660
• Other study ID #: APPOSTEL-1
• Status: Completed
• Phase: N/A
• First received: November 25, 2014
• Last updated: April 17, 2018
• Start date: November 2014
• Est. completion date: August 30, 2016

Study information

• Verified date: April 2018
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: August 30, 2016
• Est. primary completion date: August 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Substance-Related Disorders

Intervention

Device:
• electronic medication dispenser (medido)
Automated dispense of medication through an electronic dispenser

Locations

Country	Name	City	State
Switzerland	Outpatient addiction service, University Psychiatric Clinics	Basel

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Psychiatric Hospital of the University of Basel, University of Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Taking Adherence (Number of days with correctly dispensed pouches (%)	Number of days with correctly dispensed pouches (%)	continuous, up to 24 weeks
Secondary	Timing adherence (number of correctly dispensed pouches within predefined time-frame (%)	number of correctly dispensed pouches within predefined time-frame (%)	continuous, up to 24 weeks
Secondary	Patients' specific routine parameters according to condition(s) of participant (composite outcome)	Individual clinical outcomes, eg blood pressure, blood sugar, HIV count...	up to 24 weeks
Secondary	Psychological distress	SCL-90R self-report questionnaire	inclusion, week 12, 24, 36
Secondary	Quality of Life	SF-12 self-report questionnaire	inclusion, weeks 3, 6, 9, 12, 15, 18, 21, 24, 36
Secondary	Satisfaction	self-report questionnaire, interview	week 12, 24, 36
Secondary	Instrumental Activities of Daily Living	Instrumental Activities of Daily Living Scale (Lawton-Brody)	inclusion, week 12, 24, 36
Secondary	Cognitive Impairment	Montreal Cognitive Assessment	inclusion, week 12, 24, 36