Medication AdherenceNCT04339296
Connected Healthcare for Individuals Living at Home With Chronic Conditions
A study testing Spencer in people with Medication Adherence and Medication Compliance, run by Alberta Health Services, Calgary at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medication Adherence, Medication Compliance, Medication Nonadherence
- What is being tested?
- Spencer
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2019to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with moderate to severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medication Dispensing System to Support Medication Adherence for Individuals Living at Home With Chronic Conditions: A Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Medication Adherence, Medication Compliance, Medication Nonadherence, Hypertension, Diabetes, Arthritis
- Being tested
- Spencer
- Keywords
- Medication dispenser, Medication adherence, Polypharmacy, Chronic conditions, Aging and seniors, Community-dwelling
- Medical subject headings
- Medication Adherence, Hypertension, Diabetes Mellitus, Arthritis, Chronic Pain, Asthma, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpencerDevice
Also called Medication Dispensing System (MDS)
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention group included medication management with Spencer. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start1 Mar 2019
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alberta Health Services, Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Aging and Brain Health Innovation, Catalyst Healthcare Ltd.
- Responsible party
- Principal investigator, Mubashir Aslam Arain, Alberta Health Services, Calgary
- Investigators
- Mubashir A Arain, PhD, Principal investigator, Alberta Health services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339296
- Sponsor's protocol ID
- I2P2-3-00153
- Status last verified
- Sep 2020
- First submitted
- 6 Apr 2020
- Last updated
- 20 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 35691614Arain 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.
PubMed 33446126
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Dispensing System to Support Medication Adherence for Individuals Living at Home With Chronic Conditions: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04339296
- Acronym / sponsor ID
- I2P2-3-00153
- Conditions
- Medication Adherence, Medication Compliance, Medication Nonadherence, Hypertension, Diabetes, Arthritis
- Keywords
- Medication dispenser, Medication adherence, Polypharmacy, Chronic conditions, Aging and seniors, Community-dwelling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Alberta Health Services, CalgaryUniversity, hospital or other
- Collaborators
- Centre for Aging and Brain Health Innovation, Catalyst Healthcare Ltd.
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 9 Apr 2020 (actual)
- Results
- Posted 20 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: SpencerIntervention group included medication management with 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with moderate to severe cognitive impairment
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 |
|---|---|---|
| SpencerAlso: Medication Dispensing System (MDS)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. | Device | Intervention group |
Primary outcome
Recorded Medication Adherence
Time frame: 26 weeks
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.
Self-reported Medication Adherence
Time frame: 6-months
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35691614Chan 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.
- Derived from this study: PubMed 33446126Arain 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.
- Individual participant dataSharing planned: No. 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.
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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.
Mubashir A Arain, PhD principal investigator
Alberta Health services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spencer in people with Medication Adherence and Medication Compliance, run by Alberta Health Services, Calgary at 1 site in Canada.
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 5 inclusion and 1 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 20 Oct 2020. 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 Canada. 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?
Yes. Results are posted in the registry (first posted 20 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Recorded Medication Adherence (time frame: 26 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04339296, which also lists 2 linked publications.
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 20 Oct 2020.