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Completed

NCT Number: NCT03513224

The eDosette Pilot Study

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.

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Key information

Conditions

Medication Adherence Behavior Health Behavior Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

eDosette

Other

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.

Primary outcomes

  1. Four-week medication adherence rate

    Time frame: 4 weeks

    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.

Secondary outcomes

  1. Thematic content of pharmacist-participant discussion during the study

    Time frame: 4 weeks

    Retrospective chart reviews were performed to extract content on these discussions.

  2. Frequency of medication changes noted

    Time frame: 4 weeks

    Retrospective chart reviews were performed to extract content on these changes.

  3. Change in MRCI score

    Time frame: 4 weeks

    Medication Regimen Complexity Index (MRCI) were calculated at baseline and 4 weeks by the pharmacist based on medication listed obtained from dispensing pharmacies.

  4. Participant feedback

    Time frame: 4 weeks

    An exit-feedback survey was administered asking participants to rank their experience with the eDosette. The survey also asked participants to identify the three best and worst aspects of the eDosette.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

The Use of an Electronic Medication Administration-monitoring Device to Improve Medication Adherence and Reduce Medication Regimen Complexity in Community Dwelling Seniors: A Prospective Pilot Study

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 1, 2018
Registry last updated
May 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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