Hypertension Clinical Trial
Official title:
Harnessing Mobile Health Technology to Personalize the Care of Chronic Kidney Disease Patients: Medication Domain Randomized Controlled Trial
Verified date | November 2017 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 182 |
Est. completion date | September 26, 2017 |
Est. primary completion date | September 26, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Incident or prevalent patients who are: =18 years of age - English-speaking - Able and willing to provide informed consent Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | University Health Network | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | Canadian Institutes of Health Research (CIHR) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Medication Discrepancy | The change in unintentional medication discrepancy rate from baseline to the last (12 months) visit. | One year (12 months) | |
Secondary | Clinic Blood Pressure | Mean change in systolic and diastolic BP measured by clinic BP Tru automated machine | 6, 12 months | |
Secondary | Ambulatory Blood Pressure | Mean change in systolic and diastolic BP measured by average 7 day home ambulatory BP readings | 12 months | |
Secondary | CKD specific laboratory values (hemoglobin) | Proportion of patients in target hemoglobin, defined as hemoglobin of 100 to 120 g/L | 12 months | |
Secondary | CKD specific laboratory values (potassium) | Proportion of patients in target potassium ; defined as potassium of 3.2 to 5.0 mmol/L | 12 months | |
Secondary | CKD specific laboratory values (phosphate) | Proportion of patients in target phosphate; defined as phosphate range of less than 1.5 mmol/L. | 12 months | |
Secondary | Medication Discrepancy Proportion of Patients | Proportion of patients more than 1 unintentional discrepancy | 12 months | |
Secondary | Satisfaction | Key feedback on usability, experience and perceived strengths and weakness of mobile app | 12 months | |
Secondary | Quality of Life | Change in health utility scores as captured in the EQ-5D questionnaire | 12 months |
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