Adherence to Polypharmacy in Patients With Opioid Substitution Therapy Using Electronics (APPOSTEL)

April 17, 2018 updated by: University Hospital, Basel, Switzerland

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland
        • Outpatient addiction service, University Psychiatric Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: electronic medication dispenser
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)
Automated dispense of medication through an electronic dispenser
Other Names:
  • medido

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Taking Adherence (Number of days with correctly dispensed pouches (%)
Time Frame: continuous, up to 24 weeks
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 (%)
Time Frame: continuous, up to 24 weeks
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)
Time Frame: up to 24 weeks
Individual clinical outcomes, eg blood pressure, blood sugar, HIV count...
up to 24 weeks
Psychological distress
Time Frame: inclusion, week 12, 24, 36
SCL-90R self-report questionnaire
inclusion, week 12, 24, 36
Quality of Life
Time Frame: inclusion, weeks 3, 6, 9, 12, 15, 18, 21, 24, 36
SF-12 self-report questionnaire
inclusion, weeks 3, 6, 9, 12, 15, 18, 21, 24, 36
Satisfaction
Time Frame: week 12, 24, 36
self-report questionnaire, interview
week 12, 24, 36
Instrumental Activities of Daily Living
Time Frame: inclusion, week 12, 24, 36
Instrumental Activities of Daily Living Scale (Lawton-Brody)
inclusion, week 12, 24, 36
Cognitive Impairment
Time Frame: inclusion, week 12, 24, 36
Montreal Cognitive Assessment
inclusion, week 12, 24, 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

University of Basel
Psychiatric Hospital of the University of Basel

Investigators

  • Study Chair: Kurt Hersberger, Prof. MD, University Hospital, Basel, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2014

Primary Completion (ACTUAL)

August 30, 2016

Study Completion (ACTUAL)

August 30, 2016

Study Registration Dates

First Submitted

November 25, 2014

First Submitted That Met QC Criteria

March 2, 2016

First Posted (ESTIMATE)

March 8, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 18, 2018

Last Update Submitted That Met QC Criteria

April 17, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APPOSTEL-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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