Back to resultsAdherence to Polypharmacy in Patients With Opioid Substitution Therapy Using Electronics (APPOSTEL)
Primary Purpose
Substance-Related Disorders
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
electronic medication dispenser (medido)
Sponsored by
About this trial
This is an interventional health services research trial for Substance-Related Disorders focused on measuring Pharmaceutical Care, Adherence, Polypharmacy, e-Health, opioid substitution therapy
Eligibility Criteria
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)
Sites / Locations
- Outpatient addiction service, University Psychiatric Clinics
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
electronic medication dispenser
Arm Description
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.
Outcomes
Primary Outcome Measures
Taking Adherence (Number of days with correctly dispensed pouches (%)
Number of days with correctly dispensed pouches (%)
Secondary Outcome Measures
Timing adherence (number of correctly dispensed pouches within predefined time-frame (%)
number of correctly dispensed pouches within predefined time-frame (%)
Patients' specific routine parameters according to condition(s) of participant (composite outcome)
Individual clinical outcomes, eg blood pressure, blood sugar, HIV count...
Psychological distress
SCL-90R self-report questionnaire
Quality of Life
SF-12 self-report questionnaire
Satisfaction
self-report questionnaire, interview
Instrumental Activities of Daily Living
Instrumental Activities of Daily Living Scale (Lawton-Brody)
Cognitive Impairment
Montreal Cognitive Assessment
Full Information
NCT ID
NCT02701660
First Posted
November 25, 2014
Last Updated
April 17, 2018
Sponsor
University Hospital, Basel, Switzerland
Collaborators
University of Basel, Psychiatric Hospital of the University of Basel
1. Study Identification
Unique Protocol Identification Number
NCT02701660
Brief Title
Adherence to Polypharmacy in Patients With Opioid Substitution Therapy Using Electronics
Acronym
APPOSTEL
Official Title
Remote-controlled Dispensing of Medication and Electronic Monitoring of Adherence in Ambulatory Patients With Opioid Dependency Syndrome and Polypharmacy - a Feasibility Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
November 2014 (Actual)
Primary Completion Date
August 30, 2016 (Actual)
Study Completion Date
August 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
University of Basel, Psychiatric Hospital of the University of Basel
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders
Keywords
Pharmaceutical Care, Adherence, Polypharmacy, e-Health, opioid substitution therapy
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
electronic medication dispenser
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
electronic medication dispenser (medido)
Other Intervention Name(s)
medido
Intervention Description
Automated dispense of medication through an electronic dispenser
Primary Outcome Measure Information:
Title
Taking Adherence (Number of days with correctly dispensed pouches (%)
Description
Number of days with correctly dispensed pouches (%)
Time Frame
continuous, up to 24 weeks
Secondary Outcome Measure Information:
Title
Timing adherence (number of correctly dispensed pouches within predefined time-frame (%)
Description
number of correctly dispensed pouches within predefined time-frame (%)
Time Frame
continuous, up to 24 weeks
Title
Patients' specific routine parameters according to condition(s) of participant (composite outcome)
Description
Individual clinical outcomes, eg blood pressure, blood sugar, HIV count...
Time Frame
up to 24 weeks
Title
Psychological distress
Description
SCL-90R self-report questionnaire
Time Frame
inclusion, week 12, 24, 36
Title
Quality of Life
Description
SF-12 self-report questionnaire
Time Frame
inclusion, weeks 3, 6, 9, 12, 15, 18, 21, 24, 36
Title
Satisfaction
Description
self-report questionnaire, interview
Time Frame
week 12, 24, 36
Title
Instrumental Activities of Daily Living
Description
Instrumental Activities of Daily Living Scale (Lawton-Brody)
Time Frame
inclusion, week 12, 24, 36
Title
Cognitive Impairment
Description
Montreal Cognitive Assessment
Time Frame
inclusion, week 12, 24, 36
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kurt Hersberger, Prof. MD
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Study Chair
Facility Information:
Facility Name
Outpatient addiction service, University Psychiatric Clinics
City
Basel
Country
Switzerland
12. IPD Sharing Statement
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Adherence to Polypharmacy in Patients With Opioid Substitution Therapy Using Electronics
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