Adherence to Polypharmacy in Patients With Opioid Substitution Therapy Using Electronics

Study Overview
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Brief Summary
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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.

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

Conditions
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Substance-Related Disorders

Intervention / Treatment
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* Device: electronic medication dispenser (medido)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: electronic medication dispenser<br>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. | Device: electronic medication dispenser (medido)<br>* Automated dispense of medication through an electronic dispenser<br>* Other names: medido;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Taking Adherence (Number of days with correctly dispensed pouches (%) | Number of days with correctly dispensed pouches (%) | continuous, up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Psychological distress | SCL-90R self-report questionnaire | inclusion, week 12, 24, 36 | 
| Quality of Life | SF-12 self-report questionnaire | inclusion, weeks 3, 6, 9, 12, 15, 18, 21, 24, 36 | 
| Satisfaction | self-report questionnaire, interview | week 12, 24, 36 | 
| Instrumental Activities of Daily Living | Instrumental Activities of Daily Living Scale (Lawton-Brody) | inclusion, week 12, 24, 36 | 
| Cognitive Impairment | Montreal Cognitive Assessment | inclusion, week 12, 24, 36 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmaceutical Care, Adherence, Polypharmacy, e-Health, opioid substitution therapy