Study Stopped
The study was stopped early due to lack of recruitment/difficulty meeting recruitment goal.
Mobile Health Platform for Surveillance of Kidney Stone
Usage of a Mobile Health Platform for Surveillance of Kidney Stone Formers
1 other identifier
interventional
75
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2022
CompletedFirst Posted
Study publicly available on registry
May 25, 2022
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJanuary 21, 2026
March 1, 2024
2.4 years
May 6, 2022
January 16, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
change in patient quality of life
assess this using the validated Wisconsin Stone Quality of Life questionnaire
0 to 6 months
change in patient quality of life
assess this using the validated Wisconsin Stone Quality of Life questionnaire
0 to 12 months
Change in overall stone health scale
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
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
Study Arms (3)
Standard Care
PLACEBO COMPARATORstandard care + mHealth (GetWell)
ACTIVE COMPARATORmHealth (GetWell)
ACTIVE COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwestern University
Chicago, Illinois, 60611, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Endourology/Stone Division
Study Record Dates
First Submitted
May 6, 2022
First Posted
May 25, 2022
Study Start
August 1, 2022
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
January 21, 2026
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share