Mobile Health Technology for Chronic Kidney Disease Patients: Medication Management

NCT02905474 | Completed

• 1 other identifier: UHN-16-5002-BE
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Renal Insufficiency, Chronic; Hypertension; Medication Reconciliation; Mobile Applications

Keywords

chronic kidney disease, mobile applications, mHealth, medication reconciliation, self-management

Outcome Measures

Primary Outcomes (1)

• Medication Discrepancy

  The change in unintentional medication discrepancy rate from baseline to the last (12 months) visit.

  One year (12 months)

Secondary Outcomes (8)

• Clinic Blood Pressure

  6, 12 months

• Ambulatory Blood Pressure

  12 months

• CKD specific laboratory values (hemoglobin)

  12 months

• CKD specific laboratory values (potassium)

  12 months

• CKD specific laboratory values (phosphate)

  12 months

Study Arms (2)

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.

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.

Other: Usual Care; Device: Commercially available mobile medication app

Interventions

Usual Care OTHER

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.

My MedRec (Commercial App); eKidneyCare

Integrated mobile medication app DEVICE

Use of mobile app to maintain, manage medication list on a smartphone device that allows for bidirectional transfer of medication information

eKidneyCare

Commercially available mobile medication app DEVICE

Use of mobile app to manually record and maintain medication records with no integration to databases.

My MedRec (Commercial App)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Incident or prevalent patients who are: ≥18 years of age
• English-speaking
• Able and willing to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (1)

• 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.

  PMID: 33737321 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertension

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Stephanie W Ong, BScPHM, MSc

  UHN

  PRINCIPAL INVESTIGATOR

• Alexander G Logan, MD, FRCP(C)

  Samuel Lunenfeld Research Institute, Mount Sinai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 19, 2016
• Study Start: May 1, 2016
• Primary Completion: September 26, 2017
• Study Completion: September 26, 2017
• Last Updated: November 9, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)