Renal Insufficiency, ChronicNCT02905474
Mobile Health Technology for Chronic Kidney Disease Patients: Medication Management
A study testing Integrated mobile medication app and Commercially available mobile medication app in people with Renal Insufficiency, Chronic and Hypertension, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Patients with complex, long-lasting conditions such as chronic kidney disease (CKD) often take multiple medications and frequently have serious medication problems, arising from poor communication between doctors and patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency, Chronic, Hypertension, Medication Reconciliation
- What is being tested?
- Integrated mobile medication app and Commercially available mobile medication app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteCanada
- Study dates
- May 2016to 26 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Incident or prevalent patients who are: ≥18 years of age
- English-speaking
- Able and willing to provide informed consent
Who cannot join
- CKD stages 1 to 3a (estimated glomerular filtration rate of ≥ 45 ml/min)
- likely to receive a kidney transplant within 3 months of enrollment into the trial
- living in a long-term care or rehabilitation institution, likely to have their care transferred to another facility outside participating clinic areas during the course of the study
- taking less than 2 prescription medications
- planning to travel or live consecutively out of the province of Ontario for more than one month
- participating in another intervention trial,
- cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Harnessing Mobile Health Technology to Personalize the Care of Chronic Kidney Disease Patients: Medication Domain Randomized Controlled Trial
Patients with complex, long-lasting conditions such as chronic kidney disease (CKD) often take multiple medications and frequently have serious medication problems, arising from poor communication between doctors and patients. Prescription errors or misunderstandings can cause harm and lead to emergency room visits or even hospitalizations. To address these issues, medication reconciliation is now used by hospitals as a way to confirm the medication list of patients on admission to and discharge from hospital. However, a similar process does not exist outside the hospital setting. In recent years patients have become more proactive in undertaking activities with a direct bearing on their health. Such activities may include maintaining an accurate list of their medications. The rapid growth of the digital health arena has led to the development of a large number of commercially available mobile medication management apps for patients. These digital tools are 'stand-alone' products that are not integrated with the patients' pharmacy or health record system. They rely on patients to enter the list of their medications and update it as necessary. Moreover, few have a function to communicate medication changes or problems with their healthcare providers. Recently, an integrated smartphone, eKidneyCare, app system was developed with a medication management feature to help patients maintain an accurate mobile medication list. Patients' current medication information in the pharmacy database is uploaded onto their by a pharmacist and changes are tracked regularly through a bi-directional communication system. Updates to the medication list occur seamlessly by the pharmacist, and patients and their physicians are notified about any medication errors or serious adverse events. This study will determine whether our eKidneyCare app with its medication management feature will decrease medication errors and improve patient safety compared to the more traditional way of managing medications.
Read the detailed description
Background: Patients who have complicated conditions such as chronic kidney disease (CKD) are at high risk for problems related to their medications. Often these problems occur because doctors and patients do not communicate the right type of medication information to each other. This causes many prescribing errors and can lead to patient harm, emergency visits, or hospitalizations. To address this communication problem, hospitals now use a process called "medication reconciliation" to confirm the medications patients are taking when they enter and leave the hospital. However, the way that medication reconciliation is currently being done, patients are not actively engaged or given tools to effectively communicate the medications they are taking, changes that have been made, and what they are having trouble with. Directly engaging patients in this process might help solve this problem, and mobile technologies on smartphones may be a solution. Our study team has developed a mobile application (app) called eKidneyCare, which has a specific medication component to help patients communicate their medication information to all their doctors. This app can feed medication information from the clinic's medical record to the patient's smartphone, and any changes made to the medication list can be entered by the patient and sent back to the central server to notify their doctors.
Study Design: We propose to conduct an open-label randomized controlled trial to assess the medication related effectiveness and stakeholders' satisfaction of the eKidneyCare mobile app compared to commercially available mobile apps like My MedRec for 12 months. This study will be conducted in the renal clinics at University Health Network who oversee the clinical management of advanced stage 4 to 5 CKD patients and end stage renal disease. On average, patients of this clinic are aged 65 years or more and take 10-15 medications per day.
Objectives and Hypotheses Primary 1) To evaluate the effect of the eKidneyCare mobile app compared to a commercially available stand alone mobile app (My MedRec) on unintentional medication discrepancies in CKD patients. The use of the eKidneyCare app will have a greater reduction medication discrepancy rates by enhancing patient self-care through bidirectional communication of information.
Secondary
- To determine the effect of the eKidneyCare mobile app compared to commercially available stand along mobile app (My MedRec) on CKD-specific clinical outcomes. Patients actively engaged in medication management will translate to improved clinical parameters such as better blood pressure control.
- To evaluate the direct costs and quality of life (QOL) associated with incorporating the eKidneyCare mobile app compared to commercially available stand along mobile app (My MedRec). Reduction in the unintentional medication discrepancy rate will offset the cost of using the medication self-care app and will improve patients' quality of life.
- To assess stakeholders' satisfaction in using the mobile app to manage CKD. Medication self-care app will increase satisfaction among patients.
This study will evaluated if this app will decrease errors related to medications. It is hypothesized that if patients use this app to report their medications to their doctors, fewer errors will occur, which should eventually lead to reduced patient harm and healthcare use.
- Conditions
- Renal Insufficiency, Chronic, Hypertension, Medication Reconciliation, Mobile Applications
- Being tested
- Usual Care, Integrated mobile medication app, Commercially available mobile medication app
- Keywords
- chronic kidney disease, mobile applications, mHealth, medication reconciliation, self-management
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareOther
Usual standard CKD care involves an outpatient clinic visit every 3 to 4 months (at minimum every 6 months) for a clinical assessment by their renal clinical care team.
Integrated mobile medication appDevice
Use of mobile app to maintain, manage medication list on a smartphone device that allows for bidirectional transfer of medication information
Commercially available mobile medication appDevice
Use of mobile app to manually record and maintain medication records with no integration to databases.
| Study group | Role | What they receive |
|---|---|---|
| eKidneyCare | Experimental | The eKidneyCare mobile app has an active interface with the renal clinic pharmacy system to allow for updated medication profiles to be sent directly to the patient's smartphone for the renal clinic pharmacy information system. Receives: Other: Usual Care; Device: Integrated mobile medication app |
| My MedRec (Commercial App) | Active comparator | My MedRec is a commercially available mobile app which allows a user to have a personal health record along with keeping track of their medications. The My MedRec mobile app allows users to track blood pressure and medication information through manual data entry with the app. It is a stand alone mobile app which stores specified medical information on the native smartphone device and does not connect to any other servers or databases. Receives: Other: Usual Care; Device: Commercially available mobile medication app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Discrepancy
The change in unintentional medication discrepancy rate from baseline to the last (12 months) visit.
Measured: One year (12 months)
Secondary outcomes (8)
Clinic Blood Pressure
Mean change in systolic and diastolic BP measured by clinic BP Tru automated machine
Measured: 6, 12 months
Ambulatory Blood Pressure
Mean change in systolic and diastolic BP measured by average 7 day home ambulatory BP readings
Measured: 12 months
CKD specific laboratory values (hemoglobin)
Proportion of patients in target hemoglobin, defined as hemoglobin of 100 to 120 g/L
Measured: 12 months
CKD specific laboratory values (potassium)
Proportion of patients in target potassium ; defined as potassium of 3.2 to 5.0 mmol/L
Measured: 12 months
CKD specific laboratory values (phosphate)
Proportion of patients in target phosphate; defined as phosphate range of less than 1.5 mmol/L.
Measured: 12 months
Medication Discrepancy Proportion of Patients
Proportion of patients more than 1 unintentional discrepancy
Measured: 12 months
Satisfaction
Key feedback on usability, experience and perceived strengths and weakness of mobile app
Measured: 12 months
Quality of Life
Change in health utility scores as captured in the EQ-5D questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startMay 2016
- Primary completion26 Sep 2017
- Study completion26 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Stephanie W Ong, BScPHM, MSc, Principal investigator, UHNAlexander G Logan, MD, FRCP(C), Principal investigator, Samuel Lunenfeld Research Institute, Mount Sinai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905474
- Sponsor's protocol ID
- UHN-16-5002-BE
- Status last verified
- Nov 2017
- First submitted
- 14 Sep 2016
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Ong SW, Jassal SV, Porter EC, Min KK, Uddin A, Cafazzo JA, Rac VE, Tomlinson G, Logan AG. Digital Applications Targeting Medication Safety in Ambulatory High-Risk CKD Patients: Randomized Controlled Clinical Trial. Clin J Am Soc Nephrol. 2021 Apr 7;16(4):532-542. doi: 10.2215/CJN.15020920. Epub 2021 Mar 18.
PubMed 33737321
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harnessing Mobile Health Technology to Personalize the Care of Chronic Kidney Disease Patients: Medication Domain Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02905474
- Acronym / sponsor ID
- UHN-16-5002-BE
- Conditions
- Renal Insufficiency, Chronic, Hypertension, Medication Reconciliation, Mobile Applications
- Keywords
- chronic kidney disease, mobile applications, mHealth, medication reconciliation, self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- May 2016
- Primary completion
- 26 Sep 2017 (actual)
- Study completion
- 26 Sep 2017 (actual)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with complex, long-lasting conditions such as chronic kidney disease (CKD) often take multiple medications and frequently have serious medication problems, arising from poor communication between doctors and patients. Prescription errors or misunderstandings can cause harm and lead to emergency room visits or even hospitalizations. To address these issues, medication reconciliation is now used by hospitals as a way to confirm the medication list of patients on admission to and discharge from hospital. However, a similar process does not exist outside the hospital setting. In recent years patients have become more proactive in undertaking activities with a direct bearing on their health. Such activities may include maintaining an accurate list of their medications. The rapid growth of the digital health arena has led to the development of a large number of commercially available mobile medication management apps for patients. These digital tools are 'stand-alone' products that are not integrated with the patients' pharmacy or health record system. They rely on patients to enter the list of their medications and update it as necessary. Moreover, few have a function to communicate medication changes or problems with their healthcare providers. Recently, an integrated smartphone, eKidneyCare, app system was developed with a medication management feature to help patients maintain an accurate mobile medication list. Patients' current medication information in the pharmacy database is uploaded onto their by a pharmacist and changes are tracked regularly through a bi-directional communication system. Updates to the medication list occur seamlessly by the pharmacist, and patients and their physicians are notified about any medication errors or serious adverse events. This study will determine whether our eKidneyCare app with its medication management feature will decrease medication errors and improve patient safety compared to the more traditional way of managing medications.
Detailed description
Background: Patients who have complicated conditions such as chronic kidney disease (CKD) are at high risk for problems related to their medications. Often these problems occur because doctors and patients do not communicate the right type of medication information to each other. This causes many prescribing errors and can lead to patient harm, emergency visits, or hospitalizations. To address this communication problem, hospitals now use a process called "medication reconciliation" to confirm the medications patients are taking when they enter and leave the hospital. However, the way that medication reconciliation is currently being done, patients are not actively engaged or given tools to effectively communicate the medications they are taking, changes that have been made, and what they are having trouble with. Directly engaging patients in this process might help solve this problem, and mobile technologies on smartphones may be a solution. Our study team has developed a mobile application (app) called eKidneyCare, which has a specific medication component to help patients communicate their medication information to all their doctors. This app can feed medication information from the clinic's medical record to the patient's smartphone, and any changes made to the medication list can be entered by the patient and sent back to the central server to notify their doctors.
Study Design: We propose to conduct an open-label randomized controlled trial to assess the medication related effectiveness and stakeholders' satisfaction of the eKidneyCare mobile app compared to commercially available mobile apps like My MedRec for 12 months. This study will be conducted in the renal clinics at University Health Network who oversee the clinical management of advanced stage 4 to 5 CKD patients and end stage renal disease. On average, patients of this clinic are aged 65 years or more and take 10-15 medications per day.
Objectives and Hypotheses Primary 1) To evaluate the effect of the eKidneyCare mobile app compared to a commercially available stand alone mobile app (My MedRec) on unintentional medication discrepancies in CKD patients. The use of the eKidneyCare app will have a greater reduction medication discrepancy rates by enhancing patient self-care through bidirectional communication of information.
Secondary
- To determine the effect of the eKidneyCare mobile app compared to commercially available stand along mobile app (My MedRec) on CKD-specific clinical outcomes. Patients actively engaged in medication management will translate to improved clinical parameters such as better blood pressure control.
- To evaluate the direct costs and quality of life (QOL) associated with incorporating the eKidneyCare mobile app compared to commercially available stand along mobile app (My MedRec). Reduction in the unintentional medication discrepancy rate will offset the cost of using the medication self-care app and will improve patients' quality of life.
- To assess stakeholders' satisfaction in using the mobile app to manage CKD. Medication self-care app will increase satisfaction among patients.
This study will evaluated if this app will decrease errors related to medications. It is hypothesized that if patients use this app to report their medications to their doctors, fewer errors will occur, which should eventually lead to reduced patient harm and healthcare use.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eKidneyCare | Experimental | Other: Usual Care, Device: Integrated mobile medication appThe eKidneyCare mobile app has an active interface with the renal clinic pharmacy system to allow for updated medication profiles to be sent directly to the patient's smartphone for the renal clinic pharmacy information system. |
| My MedRec (Commercial App) | Active comparator | Other: Usual Care, Device: Commercially available mobile medication appMy MedRec is a commercially available mobile app which allows a user to have a personal health record along with keeping track of their medications. The My MedRec mobile app allows users to track blood pressure and medication information through manual data entry with the app. It is a stand alone mobile app which stores specified medical information on the native smartphone device and does not connect to any other servers or databases. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Incident or prevalent patients who are: ≥18 years of age
- English-speaking
- Able and willing to provide informed consent
Key exclusion criteria (7 listed)
- CKD stages 1 to 3a (estimated glomerular filtration rate of ≥ 45 ml/min)
- likely to receive a kidney transplant within 3 months of enrollment into the trial
- living in a long-term care or rehabilitation institution, likely to have their care transferred to another facility outside participating clinic areas during the course of the study
- taking less than 2 prescription medications
- planning to travel or live consecutively out of the province of Ontario for more than one month
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 |
|---|---|---|
| Usual CareUsual standard CKD care involves an outpatient clinic visit every 3 to 4 months (at minimum every 6 months) for a clinical assessment by their renal clinical care team. | Other | My MedRec (Commercial App), eKidneyCare |
| Integrated mobile medication appUse of mobile app to maintain, manage medication list on a smartphone device that allows for bidirectional transfer of medication information | Device | eKidneyCare |
| Commercially available mobile medication appUse of mobile app to manually record and maintain medication records with no integration to databases. | Device | My MedRec (Commercial App) |
Primary outcome
Medication Discrepancy
Time frame: One year (12 months)
The change in unintentional medication discrepancy rate from baseline to the last (12 months) visit.
8 secondary outcomes
Clinic Blood Pressure
Time frame: 6, 12 months
Ambulatory Blood Pressure
Time frame: 12 months
CKD specific laboratory values (hemoglobin)
Time frame: 12 months
CKD specific laboratory values (potassium)
Time frame: 12 months
CKD specific laboratory values (phosphate)
Time frame: 12 months
Medication Discrepancy Proportion of Patients
Time frame: 12 months
Satisfaction
Time frame: 12 months
Quality of Life
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
- Derived from this study: PubMed 33737321Ong SW, Jassal SV, Porter EC, Min KK, Uddin A, Cafazzo JA, Rac VE, Tomlinson G, Logan AG. Digital Applications Targeting Medication Safety in Ambulatory High-Risk CKD Patients: Randomized Controlled Clinical Trial. Clin J Am Soc Nephrol. 2021 Apr 7;16(4):532-542. doi: 10.2215/CJN.15020920. Epub 2021 Mar 18.
- Individual participant dataSharing planned: Yes
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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.
Stephanie W Ong, BScPHM, MSc principal investigator
UHN
Alexander G Logan, MD, FRCP(C) principal investigator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated mobile medication app and Commercially available mobile medication app in people with Renal Insufficiency, Chronic and Hypertension, run by University Health Network, Toronto 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 3 inclusion and 7 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 9 Nov 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Medication Discrepancy (time frame: One year (12 months)). 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 NCT02905474, which also lists 1 linked publication.
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 9 Nov 2017.