Substance-Related DisordersAPPOSTELNCT02701660
Adherence to Polypharmacy in Patients With Opioid Substitution Therapy Using Electronics
A study testing electronic medication dispenser (medido) in people with Substance-Related Disorders, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- electronic medication dispenser (medido)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2014to 30 Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- opioid substitution treatment with Diacetylmorphine
- > 2 drugs, which can not be packaged in pouches (eg liquids)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Outpatient addiction service, University Psychiatric Clinics
Basel
About this study
Official title: 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.
- Conditions
- Substance-Related Disorders
- Being tested
- electronic medication dispenser (medido)
- Keywords
- Pharmaceutical Care, Adherence, Polypharmacy, e-Health, opioid substitution therapy
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electronic medication dispenser (medido)Device
Also called medido
Automated dispense of medication through an electronic dispenser
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: electronic medication dispenser (medido) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taking Adherence (Number of days with correctly dispensed pouches (%)
Number of days with correctly dispensed pouches (%)
Measured: continuous, up to 24 weeks
Secondary outcomes (7)
Timing adherence (number of correctly dispensed pouches within predefined time-frame (%)
number of correctly dispensed pouches within predefined time-frame (%)
Measured: 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...
Measured: up to 24 weeks
Psychological distress
SCL-90R self-report questionnaire
Measured: inclusion, week 12, 24, 36
Quality of Life
SF-12 self-report questionnaire
Measured: inclusion, weeks 3, 6, 9, 12, 15, 18, 21, 24, 36
Satisfaction
self-report questionnaire, interview
Measured: week 12, 24, 36
Instrumental Activities of Daily Living
Instrumental Activities of Daily Living Scale (Lawton-Brody)
Measured: inclusion, week 12, 24, 36
Cognitive Impairment
Montreal Cognitive Assessment
Measured: inclusion, week 12, 24, 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startNov 2014
- Primary completion30 Aug 2016
- Study completion30 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Basel, Psychiatric Hospital of the University of Basel
- Responsible party
- Sponsor
- Investigators
- Kurt Hersberger, Prof. MD, Study chair, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701660
- Sponsor's protocol ID
- APPOSTEL-1
- Acronym
- APPOSTEL
- Status last verified
- Apr 2018
- First submitted
- 25 Nov 2014
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote-controlled Dispensing of Medication and Electronic Monitoring of Adherence in Ambulatory Patients With Opioid Dependency Syndrome and Polypharmacy - a Feasibility Trial
- ClinicalTrials.gov ID
- NCT02701660
- Acronym / sponsor ID
- APPOSTEL / APPOSTEL-1
- Conditions
- Substance-Related Disorders
- Keywords
- Pharmaceutical Care, Adherence, Polypharmacy, e-Health, opioid substitution therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University of Basel, Psychiatric Hospital of the University of Basel
- Study start
- Nov 2014 (actual)
- Primary completion
- 30 Aug 2016 (actual)
- Study completion
- 30 Aug 2016 (actual)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| electronic medication dispenser | Experimental | Device: electronic medication dispenser (medido)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- opioid substitution treatment with Diacetylmorphine
- > 2 drugs, which can not be packaged in pouches (eg liquids)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electronic medication dispenser (medido)Also: medidoAutomated dispense of medication through an electronic dispenser | Device | electronic medication dispenser |
Primary outcome
Taking Adherence (Number of days with correctly dispensed pouches (%)
Time frame: continuous, up to 24 weeks
Number of days with correctly dispensed pouches (%)
7 secondary outcomes
Timing adherence (number of correctly dispensed pouches within predefined time-frame (%)
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
Psychological distress
Time frame: inclusion, week 12, 24, 36
Quality of Life
Time frame: inclusion, weeks 3, 6, 9, 12, 15, 18, 21, 24, 36
Satisfaction
Time frame: week 12, 24, 36
Instrumental Activities of Daily Living
Time frame: inclusion, week 12, 24, 36
Cognitive Impairment
Time frame: inclusion, week 12, 24, 36
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kurt Hersberger, Prof. MD study chair
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electronic medication dispenser (medido) in people with Substance-Related Disorders, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Taking Adherence (Number of days with correctly dispensed pouches (%) (time frame: continuous, up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.