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OpenTrials
Completed

NCT Number: NCT02701660

Adherence to Polypharmacy in Patients With Opioid Substitution Therapy Using Electronics

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.

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Key information

Conditions

Substance-related Disorders Chemically-Induced Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient addiction service, University Psychiatric Clinics

Basel, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

electronic medication dispenser (medido)

Device

Automated dispense of medication through an electronic dispenser

Other names: medido

Primary outcomes

  1. Taking Adherence (Number of days with correctly dispensed pouches (%)

    Time frame: continuous, up to 24 weeks

    Number of days with correctly dispensed pouches (%)

Secondary outcomes

  1. Timing adherence (number of correctly dispensed pouches within predefined time-frame (%)

    Time frame: continuous, up to 24 weeks

    number of correctly dispensed pouches within predefined time-frame (%)

  2. Patients' specific routine parameters according to condition(s) of participant (composite outcome)

    Time frame: up to 24 weeks

    Individual clinical outcomes, eg blood pressure, blood sugar, HIV count...

  3. Psychological distress

    Time frame: inclusion, week 12, 24, 36

    SCL-90R self-report questionnaire

  4. Quality of Life

    Time frame: inclusion, weeks 3, 6, 9, 12, 15, 18, 21, 24, 36

    SF-12 self-report questionnaire

  5. Satisfaction

    Time frame: week 12, 24, 36

    self-report questionnaire, interview

  6. Instrumental Activities of Daily Living

    Time frame: inclusion, week 12, 24, 36

    Instrumental Activities of Daily Living Scale (Lawton-Brody)

  7. Cognitive Impairment

    Time frame: inclusion, week 12, 24, 36

    Montreal Cognitive Assessment

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Psychiatric Hospital of the University of Basel
  • University of Basel

Registry information

Official study title

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

Acronym: APPOSTEL

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 8, 2016
Registry last updated
Apr 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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