Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04339296 |
| Other study ID # |
I2P2-3-00153 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2019 |
| Est. completion date |
July 31, 2020 |
Study information
| Verified date |
September 2020 |
| Source |
Alberta Health Services, Calgary |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Purpose: It is estimated by 2045, one in five Albertans in Canada will be 65 or older.
Medication compliance in the senior population is a significant challenge for optimizing
patient outcomes. This has significant implications when nearly 69% of medication related
hospitalizations are attributed to non-adherence and the estimated cost to the Canadian
Health care system is $7-$9 billion. The factors that contribute to poor medication adherence
are multifactorial. For example, multiple medications within a treatment regimen, increased
frequency of medication intake and a prolonged course of drug therapy all contribute to
decreased medication adherence. Almost 2/3 of those aged 65 and over take five or more
prescription drugs thus increasing the risk of adherence issues.
Therefore, therapeutic management of multiple chronic diseases can only be realized when the
individual is adherent to their prescribed pharmacological regimen. Age-related innovations
provide an enormous opportunity to enhance the quality of life for seniors and reduce
healthcare cost related to medication adherence issues. The spencer medication dispensing
device is a new integrated technology that improves medication compliance and offers
independence to seniors at home while providing real-time pharmacist and caregiver support.
Alberta Health Services (AHS) is committed to supporting and strengthening community care by
adopting age-related innovations. Hence, the aim of study is to evaluate user benefits and
effectiveness of the device for improving medication compliance in older adults and seniors
population.
Primary Research Question: Does the spencer system improve medication adherence in
individuals 50 year or older living in the community taking five plus medications?
Study Design: This Randomized Controlled Trial (RCT) with the spencer device will be
conducted from March 2019 to June 2020 in Calgary, Alberta. The data will be collected over a
six-month period, the spencer deployment will begin in April 2019 and will continue till
September 2019. This is a proof of concept study for which no formal sample size calculation
is required. A total of 100 study participants will be recruited in the study (50
intervention group and 50 in the control group). The investigators will randomly place a
participant in either the intervention group to use spencer or into the control group to
continue the using their current method of management.
Randomization: The investigators will be using block randomization which is the recommended
method for sample sizes of 50 or less in each group to balance the groups in terms of the
number of subjects they contain, and in the distribution of potential confounding variables.
The study is not blinded so the blocks will vary in sizes (10, 12, 14) to reduce the
predictability of the intervention assignment. A project assistant (a contracted staff which
will not be involved in data collection or analysis activities) will produce
computer-generated sets of random allocations in advance of the study and then sealed in
consecutively numbered opaque envelopes. Once the participants has given consent to be
included in the study, he/she will then be irreversibly randomized by opening the next sealed
envelope containing his/her assignment.
Technology Intervention: The spencer device comprises interactive tools to optimize
medication adherence and clinical outcomes. The device dispenses the patient's medications on
time with reminders by sending visual and audio alerts. The sound of the audio alerts get
louder if the medication pouch is not removed from the device by the patient. Patient have
two hour window to remove the medication pouch. If not removed, patients are considered
non-adherent for that particular time frame. Spencer allows individuals to dispense their
medication early if away from home. Medication adherence is tracked through spencer Care
platform. The medication adherence is based on an assumption that medication was administered
by a patient once the pouch was removed from the device.
Also, spencer uses a multi-disciplinary approach of care team members including pharmacists,
caregivers and spencer medication adherence platform to provide healthcare in to the homes of
the high-risk, chronically-ill population. The device supports a personalized plan that
tracks medication adherence and response to therapy. Spencer displays personalized and
condition specific questions to meet the individual goals of patients. Patients can respond
to disease specific questions in spencer. Spencer certified pharmacists have the ability to
review patient responses remotely and determine the need for reassessment, medication
reconciliation and clinical intervention as appropriate. Spencer permits intervention
remotely through Telehealth capabilities and consultation. Patient receives appointment time
directly from spencer, spencer automatically rings at designated time, and call is initiated
when patient answers with the touch of a screen. Daily tracking of medication adherence and
response to relevant clinical engagement questions will be conducted via the spencer
platform.
Through the connected devices, spencer ensures that everyone in the circle of care can
participate in the wellbeing of the patient. Spencer Assist is a mobile app that allows
caregivers and family members to support patients at home. Medication adherence data is also
accessible to the health care team. The pharmacist, health care provider and caregiver are
now electronically connected to patients and can access data regarding deviations in
adherence in real time. This connectivity allows for earlier intervention to provide the
support needed for improved healthcare outcomes.
The spencer system empowers patients to manage their treatment regimen and schedule from the
comfort of their own home. Spencer technology addresses key priority areas related to Aging
in place, independence, and caregiver support and care coordination with care team and
caregivers.
Primary outcome: The study will look at patient focused outcome and seek to understand the
influence of the medication dispensing device on medication adherence. Specifically,
increased patient medication adherence in the intervention group as a result of spencer
utilization. In the intervention group, the medication adherence data will be retrieved from
the Catalyst spencer medication adherence platform. In the control group, the medication
adherence will be will be self-reported and participants will be required to maintain missed
dosage logs. Participants will complete self-reported adherence questionnaire in both groups
(intervention and control) at baseline assessment and end of the study for comparison
purposes.
Catalyst Healthcare defines Adherence percent as actual pill (s) dispensed from the spencer
at the prescribed time within a two hour time window. Average medication adherence will be
calculated by an average of all "pill level" adherence numbers i.e. if all pills were taken
within the window, the adherence number would only contain 100 values. Alternately if no
pills were taken within the window, the adherence number would only contain 0 values.
Adherence number for a patient within the time range then divided by the total number of
pills will provide average medication adherence. Similar approach will be used for
calculating medication adherence for control group participants.
Data source and variables: the investigators will use data from multiple sources: Catalyst
technology platform for adherence; determine baseline health status of the participants and
characteristics by doing initial assessment upon enrollment; and a monthly follow-up survey
will be completed to collect medication management data and record any changes in health
status or healthcare needs
Data analysis: Data will be entered and analyzed using Statistical Package for the Social
Sciences (SPSS) version 25. Descriptive and inferential statistics will be used to compare
the baseline status of the intervention and control group as well as at the end of the
intervention period. A Chi-square test of independence will be used for categorical variables
such as the number of participants who missed one or more medication dosage in each group. An
independent sample t-test will be performed for continuous variables such as to compare the
average number of missed medicines between the intervention and control group. Any
confounding factors will be controlled in the regression model. Statistical tests for
inferential statistics will be set at 95% confidence level.
