Adherence to Polypharmacy in Patients With Opioid Substitution Therapy Using Electronics

Not Applicable

Completed

• Conditions: Substance-Related Disorders
• Interventions: Device: electronic medication dispenser (medido)

• Registration Number: NCT02701660
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-25
• Study First Submitted QC: 2016-03-02
• Study First Posted: 2016-03-08
• Primary Completion: 2016-08-30
• Study Completion: 2016-08-30
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-17
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
electronic medication dispenser	electronic medication dispenser (medido)	An Automatic Tablet Dispensing and Packaging System is used to repack all solid oral prescription medications for each participant into unit-of-dose pouches. Every participant receives a roll with pouches for 14-28 days loaded into a dispenser installed at their homes. The electronic medication dispenser is a remote controlled, electronic medication management aid reminding the patients with acoustic alerts to take their medication.

Primary Outcome Measures

Name	Time	Method
Taking Adherence (Number of days with correctly dispensed pouches (%)	continuous, up to 24 weeks	Number of days with correctly dispensed pouches (%)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Outpatient addiction service, University Psychiatric Clinics; 🇨🇭 Basel, Switzerland