Mobile Health Monitoring for Kidney Stones

Overseen By Jenny Guo

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: No mobile phone, Impairment, Non-English, others

Stay on Your Current Meds You can continue your current medications while participating

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

150 Participants Needed

Trial Summary

What is the purpose of this trial?

We plan to investigate whether usage of a mobile health platform for surveillance of stone formers by itself or as an adjunct to standard office-appointments will improve patient compliance and adherence to treatment guidelines and ultimately improve patient care, satisfaction, quality of life, and decrease stone recurrence.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment mHealth (GetWell) for kidney stones?

Research suggests that mobile health applications can help improve the quality of life for kidney stone patients by supporting lifestyle changes, like increasing fluid intake, which is important for prevention. These technologies are generally well-accepted by patients and can aid in managing the condition. ^{1 2 3 4 5}

Is mobile health technology safe for use in managing kidney stones?

The research on mobile health apps for kidney stone management suggests they are generally safe, with most apps providing privacy policies and security measures to protect user identity. However, only one app has been tested in real-world clinical settings, indicating limited direct safety evaluations. ^{2 3 4 6 7}

How does the mobile health monitoring treatment for kidney stones differ from other treatments?

This treatment is unique because it uses mobile health applications to help manage kidney stone disease by tracking fluid intake and providing reminders, which can improve patient adherence to prevention strategies. Unlike traditional treatments that focus on medication or surgery, this approach emphasizes behavioral change and self-management through technology. ^{2 3 5 8 9}

Eligibility Criteria

This trial is for adults over 18 who have had kidney stones and meet the American Urological Association guidelines for stone evaluation. They must be willing to follow treatment advice and able to use a mobile phone app called GetWell Loop.

Inclusion Criteria

I am over 18 years old.

You meet the guidelines for getting checked for kidney stones.

I have a history of kidney stones.

Exclusion Criteria

I do not have a mobile phone to use for health updates.

I cannot use a mobile phone or answer questionnaires due to physical or cognitive issues.

I am unable to give consent for the study myself.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a mobile health platform for surveillance of kidney stone formers, either alone or as an adjunct to standard office appointments

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• mHealth (GetWell)

Trial Overview The study is testing if a mobile health platform, GetWell Loop, can improve patient care by increasing adherence to treatment guidelines compared to standard office visits alone in managing kidney stones.

Participant Groups

Group I: standard care + mHealth (GetWell) Active Control 2 Interventions

Group II: mHealth (GetWell) Active Control 1 Intervention

Group III: Standard Care Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Findings from Research

A review of 31 mobile health apps for kidney stone disease found that fluid management apps are generally of higher quality than dietary apps, scoring better in technical quality, usability, and clinical value.

While most fluid apps provide good privacy policies, only 36% allow users to consent to secondary data use, highlighting a potential privacy concern despite their effectiveness in managing kidney stone disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Evaluation of Smartphone Applications for the Medical Management of Nephrolithiasis. Winoker, JS., Koo, K., Huang, MM., et al.[2021]

A review of 986 mobile healthcare apps related to kidney stone disease identified 83 that were analyzed, revealing a significant focus on fluid tracking (54 apps) but insufficient physician involvement in their development and data security measures.

Despite the availability of various apps for education and management of kidney stone disease, there is a critical need for better regulation and oversight to ensure their accuracy, safety, and adherence to FDA and Medical Device Regulation guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current state of mobile health apps in endourology: a review of mobile platforms in marketplaces and literature. Talyshinskii, A., Bakhman, G., Hameed, BZ., et al.[2023]

References

1. Spain pubmed.ncbi.nlm.nih.gov

Usefulness and acceptability of a Smart pH meter and mobile medical App as a monitoring tool in patients with urolithiasis: short-term prospective study. [2022]

2. Italy pubmed.ncbi.nlm.nih.gov

Mobile health applications in kidney stone disease management: A reliable support for patients? [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Feasibility of Mini sipIT Behavioral Intervention to Increase Urine Volume in Patients With Kidney Stones. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Acceptability of Mobile Health Technology for Promoting Fluid Consumption in Patients With Nephrolithiasis. [2019]

5. Spain pubmed.ncbi.nlm.nih.gov

Mobile and eHealth technologies in the management and prevention of nephrolithiasis: A systematic review. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Systematic Evaluation of Smartphone Applications for the Medical Management of Nephrolithiasis. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Kidney Stone Prevalence Based on Self-Report and Electronic Health Records: Insight into the Prevalence of Active Medical Care for Kidney Stones. [2023]

8. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Metaphylaxis of urolithiasis: new look, modern approach, implementation in a mobile application]. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Current state of mobile health apps in endourology: a review of mobile platforms in marketplaces and literature. [2023]