Dipping at home: is it better, easier and more convenient? A feasibility and acceptability study of a novel home urinalysis using a smartphone application

Abstract

Background:

Monitoring proteinuria in patients with kidney disease is of crucial importance given its implications for long term disease progression and clinical management. Leveraging digital health technology to provide a clinical grade urinalysis result from home holds the potential to greatly enhance the clinical experience and workflows for patients, caregivers and providers. The goal of this study was to evaluate the acceptability and feasibility of a home-based urinalysis kit using a smartphone application.

Methods:

A prospective cohort study of children and young adults (5–21 years of age) at a single pediatric center. The study received ethical board approval. Families performed a home urine test using the Healthy.io smartphone app. The app was compared with standard of care of either home dipstick monitoring or urinalysis performed in clinic or a local laboratory. Patient satisfaction was compared between the new app and current practice.

Results:

103 children, 63 (61%) male and median age 10.9 years (inter-quartile range 7.8–14.2), were enrolled. Primary diagnosis included: 47 (46%) glomerular disease, 48 (47%) non-glomerular kidney disease, and 8 (8%) kidney transplant recipients. 101 (98%) patients reported being satisfied with the smartphone app compared to 41 (40%) patients who were satisfied with the current practice for urine protein monitoring (P<0.0001). Positive themes identified included ease of use, convenience, and immediacy and accuracy of results.

Conclusions:

The Healthy.io home urine testing app received very high rates of satisfaction among patients and caregivers compared to current practice and holds great potential to enhance patient-centered care.

INTRODUCTION

Monitoring proteinuria in pediatric nephrology practice is of critical importance given its impact on disease progression in chronic kidney disease and clinical management for nephrotic syndrome [1–6]. Among kidney transplant recipients, it has been demonstrated that improved control of proteinuria can decrease renal allograft deterioration[7]. Obtaining a urinalysis is standard of care for all nephrology clinic visits, and certain patient populations are asked to bring a first morning urine sample from home for testing in clinic. A first morning urine sample can help distinguish between true fixed proteinuria which necessitates management versus orthostatic proteinuria which is a benign condition[8–10]. It can be challenging to consistently collect and bring in a first morning urine sample. Home urine dipstick testing for proteinuria is standard of care for children with nephrotic syndrome. Among patients with nephrotic syndrome, home testing guides management, and inaccurate readings may negatively impact care[11].

In the era of telemedicine, the utility of home-based telehealth is growing, and there has been increasing use of digital health tools for home-based screening[12–15]. Leveraging technology to provide a clinical grade urinalysis result from testing performed at home, combining convenience and accuracy, could transform and enhance clinical experience and workflows for patients and their caregivers as well as nephrology providers. This study focused on testing the acceptability and feasibility of a home-based urinalysis kit using a smartphone application (app) compared to current practice of home Albustix monitoring or clinic-based testing for proteinuria.

METHODS

Setting and participants

This study was a prospective cohort study of children, adolescents, and young adults. Participants were screened through reviewing the clinic schedule and electronic health record and approached through a phone call, email or in person. All patients enrolled had a previous urine test in the system as part of their routine care. Inclusion criteria included patients between the ages of 5 to 21 years receiving care at the Children’s Hospital of Philadelphia (CHOP) with at least one of the following diagnoses: nephrotic syndrome, lupus nephritis, chronic kidney disease, and post-kidney transplant.

All Participants or their parents/guardians needed to be English speaking (as app is in English) with a smartphone and access to internet.

Study procedures

The study team provided education about the Healthy.io smartphone kit to the patient and patient’s parent/legal guardian. Patients who were 18 years of age or older or parents/legal guardians of patients younger than 18 years provided consent via REDCap [16] and then completed a baseline survey collecting demographic information and assessing their experience with the current practice for urine protein monitoring. Kits were then sent to the patient’s home, and the link for downloading the app was sent via a text message to the patient’s/guardian’s smartphone.

This novel testing approach requires two components: (1) the Dip.io smartphone application and (2) the Dip.io testing kit. The smartphone app can be downloaded to an Apple or Android device using a link that is sent via an SMS text message. The Dip.io home urine testing kit consists of one urine collection container, one urinalysis reagent strip, and a color calibration board. The smartphone app guides the user through the process of collecting the urine sample, dipping the urine reagent strip, placing the strip on the color board, and taking a picture of the board. The patients were asked to provide one random urine sample. The app then shows the results for leukocytes, nitrites, urobilinogen, blood, protein, pH, specific gravity, ketones, bilirubin, and glucose. Results were provided to patients in real-time and simultaneously sent to a web-based, HIPAA-compliant database maintained by Healthy.io and accessible to the CHOP study team. (Figure 1) The study team followed-up all test results, and results were communicated to nephrology providers. Once the urine test was performed a final survey was sent to either the patient, if over 12 years of age, or guardian asking about their experience using the Healthy.io home based urine testing kit. Nephrology providers of enrolled patients (all from CHOP) were asked to complete a brief survey at the end of the study period. Clinical data was captured from the electronic health record. The nephrotic syndrome patients routinely check their urine at home using albustics whereas the other patients drop their urine off or bring it to clinic. Patients compared their experience to their standard of care.

Figure 1:

Healthy.io’s Dip.io urinalysis testing kit

Ethical and regulatory approval

This app and device is FDA approved for clinical use.

The study was approved by the Institutional Review Board at CHOP.

Statistical analysis

A descriptive analysis was performed with continuous variables presented as medians and inter-quartile ranges (IQR) and categorical variables as frequencies and percentages. Change in patient satisfaction, measured on a 4-point scale, was tested using the Wilcoxon Signed-Rank test. Analyses were performed using SAS version 9.4 [17] and R statistical software version 4.1. packages. [18] A two-sided alpha of 0.05 represented by p value was considered statistically significant.

RESULTS

Cohort Characteristics (Table 1)

Table 1:

Characteristics of Study Cohort

Demographic and Clinical Characteristics
Diagnosis	Percentage (Count) or Median (IQR)
Kidney Transplant	8% (8)
Glomerular Diagnosis	46% (47)
Non-Glomerular Diagnosis	47% (48)
Gender
Male	61% (63)
Female	39% (40)
Age (years)	10.9 (7.8, 14.2)
Survey Completed By
Patient	13% (13)
Parent or Guardian	87% (90)
Days to Complete	6 (2, 15)

The cohort consisted of 103 participants; 63 (61%) were male with a median age of 10.9 years (IQR 7.8–14.2). The primary diagnoses of the cohort were: 47 (46%) with glomerular disease (for example: Nephrotic syndrome, systemic lupus erythematosus, IGA nephropathy, 48 (47%) with non-glomerular kidney disease (mostly included patients with congenital anomalies of kidneys), and 8 (8%) kidney transplant recipients. Ninety (87%) of the surveys were completed by a parent or legal guardian. The median number of days to complete the home urine testing kit once it was delivered was 6 (IQR 2–15).

Current practice satisfaction

Current practice in the CHOP Division of Nephrology includes obtaining a urinalysis for all nephrology patient visits. Patients are asked to either bring in a first morning urine sample to clinic or to a lab prior to the visit for point of care testing. If clinically indicated, patients are also asked to provide an additional sample to a laboratory for further testing. Patients with nephrotic syndrome are asked to test their urine for protein at home using Albustix as prescribed by their nephrologist and contact their nephrologist if the test indicates that there is protein in the urine. From the preliminary survey, only 43/103 (43.1%) participants remembered to bring a first morning urine sample to their recent clinic visit.

New app satisfaction

Compared to providing a first morning urine sample at clinic, a majority of participants (94.3%) found using the Healthy.io home urine testing kit easier compared to current practice. As shown in Table 2, of the 103 participants who completed the study, 101 (98%) patients were satisfied with the smartphone app compared to only 41 (40%) patients who were satisfied with the current practice (P<0.0001). Patients/parents’ free text comments were divided into themes (Table 3). Participants tended to comment on the ease of use, the immediate results that are provided, and the convenience of the home urine testing kit. Additional feedback was focused on packaging, container design, and disappearance of the results view.

Table 2:

Patient satisfaction of current practice and Healthy.io home urinalysis smartphone app

Satisfaction Level	Current Practice	Healthy.io app	Significance
Very Satisfied	15% (15)	81% (84)	P<0.0001
Satisfied	25% (26)	17% (17)
Neutral	55% (57)	2% (2)
Dissatisfied	5% (5)	0% (0)

Table 3:

Written comments regarding App use, by themes *

“Things I liked about the app”		“Things I would like to improve”
Theme	Number of responses	Theme	Number of responses
Ease of use	68(37%)	Results timed out	7 (4%)
Convenience	35 (19%)	Packaging	6 (3%)
Immediate results	25 (14%)	Container shape	5 (3%)
Self-Explanatory	15 (8%)	Lack of result interpretation	5 (3%)
Accuracy	10 (5%)	Not able to pause/skip instructions	2 (1%)
Data capture	5 (3%)

• (A total of 183 comments, % presented rate of comments out of the total)

Nephrology Provider Results

Eight nephrology providers gave feedback regarding the return of results from their patients. Among the 8 providers, 5 (62.5%) thought that the Healthy.io testing kit was easier and/or superior compared to current practice. All eight providers reported they would like the home urine testing kit incorporated into current clinical practice.

DISCUSSION

With the growing field of telemedicine, expanding digital health tools to improve clinical care based at home will provide patients with additional in-home testing. A recent review of 68 studies addressing telemedicine in transplant demonstrated that smartphone apps and web-based platforms can improve patient adherence to therapy and improve care [19]. Additional studies adressing home monitoring using digital health tools have provided data on the benefit in screening for hypertension. In this study a descriptive study which was conducted to evaluate the prevalence of pediatric hypertension in 81 preschool and school age children. App users were trained with an online course. The manual systolic and diastolic blood pressure readings were entered into the application, along with the patient’s gender, age, height, and weight. The app calculated the blood pressure classification of the patient based on percentiles. [20].

The Dip.io smartphone app and kit for home-based urinalysis testing has previously demonstrated high rates of patient satisfaction. For example, women receiving prenatal care preferred obtaining a home urine sample compared to providing a sample in clinic [21]. The kit was tested among adult patients for early detection of proteinuria with high rates as well [22]. Our study was the first pediatric study using the kit. Our satisfaction rates were similarly high suggesting acceptability of this app both in the adult and pediatric patient populations. Patients’ positive feedback on the kit/app was mainly focused on the rapid results, convenience, and ease of use, while their critical feedback was focused on packaging, container design, and disappearance of the results view. Following the study these comments were being adressed by the company to improve the product.

This study has several limitations. For usage of the kit a smartphone and iternet acssess is needed. Because this was a demonstration project for feasibility and acceptability, the study results were not transmitted directly into the electronic health record (though the workflow and interface exists), requiring that a separate portal be accessed by the study team and results transmitted to providers in a care communication rather than as discrete data. This is a single center study and given the small number of providers, provider feedback was limited. Despite the limited number of comments, all providers expressed enthusiasm for incorporating the home urine testing kit into routine nephrology care. Another advantage this technology has is that it can unable color-blind patients or caregivers to do urine dipstick test at home accurately.

CONCLUSIONS

The Healthy.io home urine testing app received very high rates of satisfaction among patients, caregivers and providers compared to current practice. This app holds great potential to enhance patient-centered care in the growing era of telemedicine.