Connected Healthcare for Individuals Living at Home With Chronic Conditions

NCT ID: NCT04339296

Last Updated: 2020-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2020-07-31

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.

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; Chronic Pain; Anxiety Depression; Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention group

Intervention group included medication management with Spencer.

Group Type: EXPERIMENTAL

Spencer

Intervention Type: DEVICE

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.

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Spencer

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.

Intervention Type: DEVICE

Other Intervention Names

Medication Dispensing System (MDS)

Eligibility Criteria

Inclusion Criteria

1. English speakers

2. age 50 and over

3. diagnosed with one or more chronic condition(s) and

4. currently taking five or more prescribed oral medications.

5. City of Calgary resident

Exclusion Criteria

• Patients with moderate to severe cognitive impairment

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre for Aging and Brain Health Innovation

OTHER

Sponsor Role: collaborator

Catalyst Healthcare Ltd.

INDUSTRY

Sponsor Role: collaborator

Alberta Health Services, Calgary

OTHER

Sponsor Role: lead

Responsible Party

Mubashir Aslam Arain

Senior Research and Evaluation Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mubashir A Arain, PhD

Role: PRINCIPAL_INVESTIGATOR

Alberta Health services

Locations

East Calgary Family Care Clinic

Calgary, Alberta, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 35691614 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33446126 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

I2P2-3-00153

Identifier Type: -

Identifier Source: org_study_id