NCT02701660

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2014

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

March 8, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2016

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

1.8 years

First QC Date

November 25, 2014

Last Update Submit

April 17, 2018

Conditions

Substance-Related Disorders

Keywords

Pharmaceutical CareAdherencePolypharmacye-Healthopioid substitution therapy

Outcome Measures

Primary Outcomes (1)

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

    Number of days with correctly dispensed pouches (%)

    continuous, up to 24 weeks

Secondary Outcomes (7)

  • Timing adherence (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)

    up to 24 weeks

  • Psychological distress

    inclusion, week 12, 24, 36

  • Quality of Life

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

  • Satisfaction

    week 12, 24, 36

  • +2 more secondary outcomes

Study Arms (1)

electronic medication dispenser

EXPERIMENTAL

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)

Interventions

electronic medication dispenser (medido)DEVICE

Automated dispense of medication through an electronic dispenser

Also known as: medido
electronic medication dispenser

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • Insured with Swiss health insurance

You may not qualify if:

  • opioid substitution treatment with Diacetylmorphine
  • \> 2 drugs, which can not be packaged in pouches (eg liquids)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient addiction service, University Psychiatric Clinics

Basel, Switzerland

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Kurt Hersberger, Prof. MD

    University Hospital, Basel, Switzerland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2014

First Posted

March 8, 2016

Study Start

November 1, 2014

Primary Completion

August 30, 2016

Study Completion

August 30, 2016

Last Updated

April 18, 2018

Record last verified: 2018-04

Locations

CH(1)