At the National Kidney Foundation’s Annual Spring Clinical Meetings, the NKF, Geisinger and Healthy.io announced the launch of a novel clinical trial using a smartphone-enabled home urinalysis device for chronic kidney disease among patients with high blood pressure. The smartphone app from Healthy.io enables users to conduct a urinalysis test at home and securely share results with their clinicians.
“Early detection of CKD is crucial so that risk factors can be aggressively managed to prevent end-stage renal disease and cardiovascular disease,” Alexander Chang, MD, a practicing nephrologist and assistant professor in the Kidney Health Research Institute at Geisinger, said in a press release.
The trial, which is scheduled to begin on April 16, will examine the effect of a mailed, Healthy.io smartphone urinalysis kit (Dip.io test) to improve albuminuria screening compliance and detection of albuminuria. The trial will also examine the feasibility of pharmacists in improving management of detected albuminuria, as pharmacists will be instructed to confirm test with urine albumin/creatinine ratio and treat albuminuria.
For the trial, researchers will randomize 1,000 non-diabetic patients with hypertension who are receiving primary care at Geisinger into one of two groups. One group will receive usual care and the other will be mailed the urinalysis kit. According to the release, the home test will be mailed to 500 Geisinger patients who have been diagnosed with hypertension but who do not have diabetes. These patients will also receive instructions for downloading the smartphone app, to determine if the patient also has CKD. Geisinger patients will receive a letter and phone call educating them on the importance of screening for proteinuria from a team of nurses within the organization’s Care Gaps department. Appropriate follow-up will then be managed by the patient’s primary care provider and care team.
“This new trial using a smartphone app and urinalysis kit will provide important information on how to increase testing for CKD in this high-risk population,” Kerry Willis, PhD, chief scientific officer of the NKF, said in the release. “Our hope is that a home-based test makes it easier for patients at risk for CKD to comply with regular albuminuria screening, and that this will lead to earlier diagnosis and treatment of CKD, reducing cardiovascular risk and preserving kidney function.”