- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05389982
Mobile Health Platform for Surveillance of Kidney Stone
January 16, 2026 updated by: Amy Krambeck, Northwestern University
Usage of a Mobile Health Platform for Surveillance of Kidney Stone Formers
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- over 18 years old
- urinary tract stone formers
- meet the AUA guideline indication for metabolic stone evaluation and surveillance
- willing to pursue treatment recommendations of a metabolic workup
Exclusion Criteria:
- patients without mobile phone capability to utilize GetWell Loop,
- physical or cognitive impairment precluding usage of mobile phone or answering of questionnaires
- non-English speaking
- inability to consent to the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Standard Care
|
Office based pathway
|
|
Active Comparator: standard care + mHealth (GetWell)
|
Office based pathway
GetWell Loop utilizes an interactive health care application to allow patients to more actively participate in their care.
We plan to work with GetWell to develop a custom build plan for kidney stone formers to achieve key aspects of stone prevention and provide patient education.
This care plan will be developed using native capabilities within GetWell Loop.
|
|
Active Comparator: mHealth (GetWell)
|
GetWell Loop utilizes an interactive health care application to allow patients to more actively participate in their care.
We plan to work with GetWell to develop a custom build plan for kidney stone formers to achieve key aspects of stone prevention and provide patient education.
This care plan will be developed using native capabilities within GetWell Loop.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in patient quality of life
Time Frame: 0 to 6 months
|
assess this using the validated Wisconsin Stone Quality of Life questionnaire
|
0 to 6 months
|
|
change in patient quality of life
Time Frame: 0 to 12 months
|
assess this using the validated Wisconsin Stone Quality of Life questionnaire
|
0 to 12 months
|
|
Change in overall stone health scale
Time Frame: 0 to 6 months
|
overall stone health scale (Likert 10-point scale with 1 being "very unhappy with current stone health" and 10 being "couldn't be happier about stone health"),
|
0 to 6 months
|
|
Change in overall stone health scale
Time Frame: 0 to 12 months
|
overall stone health scale (Likert 10-point scale with 1 being "very unhappy with current stone health" and 10 being "couldn't be happier about stone health"),
|
0 to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2022
Primary Completion (Actual)
December 31, 2024
Study Completion (Actual)
December 31, 2024
Study Registration Dates
First Submitted
May 6, 2022
First Submitted That Met QC Criteria
May 21, 2022
First Posted (Actual)
May 25, 2022
Study Record Updates
Last Update Posted (Actual)
January 21, 2026
Last Update Submitted That Met QC Criteria
January 16, 2026
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Male Urogenital Diseases
- Calculi
- Pathological Conditions, Anatomical
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urolithiasis
- Urinary Calculi
- Nephrolithiasis
- Pathological Conditions, Signs and Symptoms
- Kidney Calculi
- Health Services Administration
- Delivery of Health Care
- Health Care Quality, Access, and Evaluation
- Quality of Health Care
- Quality Indicators, Health Care
- Patient Care Management
- Standard of Care
- Telemedicine
Other Study ID Numbers
- STU00216640
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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