NCT04339296

Brief Summary

Managing and taking medications as prescribed can be a difficult task. This is especially true for older adults living at home with chronic conditions while managing multiple prescribed medications. In response, Catalyst Healthcare has adopted an integrated medication dispensing system that intends to improve patient adherence to medications and quality of care through real-time pharmacists and caregiver support.Catalyst Healthcare has launched an integrated at-home medication dispenser system called spencer. Spencer is a natural extension that plugs into Catalyst's AdhereNet platform, connecting high-risk patients in home care setting to a multi-disciplinary care team in real-time. Study is funded by the Centre of Aging and Brain Health Innovation (CABHI). Investigators are conducting a randomized controlled trial with a target sample size of 100 participants to examine the efficacy of an in-home electronic medication dispensing system (MDS) on improving medication adherence in community-dwelling older adults with chronic conditions. 50 of these participants will be assigned to the intervention group (medication management with Spencer) and 50 will be assigned to the control group (medication management without Spencer). Medication adherence and patient-related data will be collected over a six-month period. Participants health status and characteristics will be obtained through baseline assessment upon enrollment. A monthly follow-up survey will be completed to collect medication management and adherence data. Adherence data for spencer-users will be collected from Catalyst Healthcare technology platform. In the control group, adherence will be measured through monthly medication logs completed by participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

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

March 1, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
3 months until next milestone

Results Posted

Study results publicly available

October 20, 2020

Completed
Last Updated

October 20, 2020

Status Verified

September 1, 2020

Enrollment Period

1.4 years

First QC Date

April 6, 2020

Results QC Date

September 1, 2020

Last Update Submit

September 25, 2020

Conditions

Keywords

Medication dispenserMedication adherencePolypharmacyChronic conditionsAging and seniorsCommunity-dwelling

Outcome Measures

Primary Outcomes (2)

  • Recorded Medication Adherence

    The intervention group adherence recording was obtained from Catalyst's AdhereNet platform. The spencer adherence was defined as percentage of medications dispensed from the system at the prescribed time. The user had a two-hour window to remove the medication pouch. If dispensed, they are given a score of 100 for the particular medication time. If not removed, the user was considered non-adherent and given a score of 0. Weekly medication adherence was calculated by taking the seven day average of daily dispensing adherence values. In the control group, adherence was measured through monthly medication calendars completed by participants. Each participant received customized calendars based on their medications timings along with instruction sheet for tracking their medications. Participants were required to mark "X" on the calendar on the day and time they missed taking their medication(s). Average adherence (weekly) was used as a primary outcome measure.

    26 weeks

  • Self-reported Medication Adherence

    The within group difference in mean rating scores of self-reported medication adherence. The adherence question asked participants to rate their medication adherence on a scale of 1 (non-adherent) to 10 (adherent).

    6-months

Study Arms (2)

Intervention group

EXPERIMENTAL

Intervention group included medication management with Spencer.

Device: Spencer

Control Group

NO INTERVENTION

The control group continued to use their current method of medication management, such as blister packs, strip packs, pill organizers and plastic prescription vials.

Interventions

SpencerDEVICE

The MDS dispenses medications on time with visual and audio reminders. The audio alert get louder if the plastic medication packet is not dispensed from the system. The MDS allows participants to dispense their medications early if they are going to be away from home. The system also displays personalized and health-condition specific questions. The pre-packaged medications are delivered by pharmacy that inserted directly into the spencer device. Spencer system is non-inclusive and approved by Health Canada.

Also known as: Medication Dispensing System (MDS)
Intervention group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English speakers
  • age 50 and over
  • diagnosed with one or more chronic condition(s) and
  • currently taking five or more prescribed oral medications.
  • City of Calgary resident

You may not qualify if:

  • Patients with moderate to severe cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East Calgary Family Care Clinic

Calgary, Alberta, Canada

Location

Related Publications (2)

  • Chan A, De Simoni A, Wileman V, Holliday L, Newby CJ, Chisari C, Ali S, Zhu N, Padakanti P, Pinprachanan V, Ting V, Griffiths CJ. Digital interventions to improve adherence to maintenance medication in asthma. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD013030. doi: 10.1002/14651858.CD013030.pub2.

  • Arain MA, Ahmad A, Chiu V, Kembel L. Medication adherence support of an in-home electronic medication dispensing system for individuals living with chronic conditions: a pilot randomized controlled trial. BMC Geriatr. 2021 Jan 14;21(1):56. doi: 10.1186/s12877-020-01979-w.

MeSH Terms

Conditions

Medication AdherenceHypertensionDiabetes MellitusArthritisChronic PainAsthmaChronic Disease

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorVascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesDisease AttributesPathologic Processes

Limitations and Caveats

Intermittent data collected because some participants were unavailable for all monthly follow-up phone calls; control participants were not consistently sending in tracking calendars; intervention participants experienced some technical issues.

Results Point of Contact

Title
Research and Evaluation Coordinator
Organization
Health Systems Evaluation & Evidence - Alberta Health Services

Study Officials

  • Mubashir A Arain, PhD

    Alberta Health services

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Participants were assigned to two groups. Intervention participants were assigned to use spencer medication dispenser system. Whereas, control participants continued to use their current method of medication management. Block randomization was used to assign the participants into the intervention or control group as soon as they enrolled in the study. Blocks varied in sizes (10, 12, 14) to reduce the predictability of the allocation assignment within participants and research staff.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research and Evaluation Consultant

Study Record Dates

First Submitted

April 6, 2020

First Posted

April 9, 2020

Study Start

March 1, 2019

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

October 20, 2020

Results First Posted

October 20, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

The investigators will be aggregating the data for research purposes and will not release participant-specific data. Also, since this research falls under the auspices of AHS, all data collection, management, and storage processes will fully comply with the Health Information Act and the Freedom of Information and Protection of Privacy Act.

Locations