NCT03513224

Brief Summary

Medication non-adherence can lead to serious health issues for older adults. This study is a four week study in older adults using a new device, the eDosette, which dispenses and records how one takes their medications, and subsequently makes this information available to the primary care team by the internet. This study aims to show that the eDosette can report how well a group of older adults living independently in the community are taking their medications (e.g. "medication adherence"). This study hopes to show that the eDosette intervention could play a role in medication adherence by improving conversations between older adults and primary care.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 1, 2018

Completed
Last Updated

May 1, 2018

Status Verified

April 1, 2018

Enrollment Period

12 months

First QC Date

April 19, 2018

Last Update Submit

April 19, 2018

Conditions

Medication Adherence

Outcome Measures

Primary Outcomes (1)

  • Four-week medication adherence rate

    Each participant's observed medication adherence for the entire study was calculated by dividing the total medication doses taken correctly by the total doses in the study. The numerator, total medication doses taken correctly is calculated by subtracting from the total doses any missed or late doses as determined by the eDosette. Missed doses is defined as any dose still present on image data after the next daily scheduled dose time); late doses is defined as any dose taken outside the two-hour time window of the average time of dose administration - e.g. 08h00-10h00 for a 09h00 average dose time. The denominator, total doses, was defined as the total number of pills prescribed for a patient to take during the study.

    4 weeks

Secondary Outcomes (4)

  • Thematic content of pharmacist-participant discussion during the study

    4 weeks

  • Frequency of medication changes noted

    4 weeks

  • Change in MRCI score

    4 weeks

  • Participant feedback

    4 weeks

Study Arms (1)

eDosette

EXPERIMENTAL
Other: eDosette

Interventions

eDosetteOTHER

The eDosette is an internet-enabled, medication administration monitoring unit that has been previously tested for feasibility in older adults. The eDosette was designed to be compatible with different types of weekly medication blister packs and dosettes, and monitors medication-taking behaviour in a patient's home. The eDosette securely transmits this information to a secure server where the information is converted to individual medication administration records. Patients can also use the eDosette to notify their primary care team of potential medication side effects.

eDosette

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • age 65 and over
  • taking five or more medications (including supplements)
  • using or willing to use a blister pack or dosette
  • currently managing their medications independently
  • living independently
  • English speaking

You may not qualify if:

  • a documented diagnosis of mild cognitive impairment or dementia
  • living in any form of assisted living facility
  • currently palliative
  • currently deemed medically unstable by their primary care team

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Siu HY, Mangin D, Howard M, Price D, Chan D. Developing and testing an electronic medication administration monitoring device for community dwelling seniors: a feasibility study. Pilot Feasibility Stud. 2017 Feb 1;3:5. doi: 10.1186/s40814-016-0118-3. eCollection 2017.

    PMID: 28168041BACKGROUND

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

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
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 19, 2018

First Posted

May 1, 2018

Study Start

September 1, 2016

Primary Completion

August 31, 2017

Study Completion

December 31, 2017

Last Updated

May 1, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share