Mobile Health Platform for Surveillance of Kidney Stone

Stone, Kidney Clinical Trial

Official title:

Usage of a Mobile Health Platform for Surveillance of Kidney Stone Formers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05389982
• Other study ID #: STU00216640
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: June 1, 2025

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: June 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Calculi
• Nephrolithiasis
• Stone, Kidney

Intervention

Other:
• 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.
• Standard Care
Office based pathway

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in patient quality of life	assess this using the validated Wisconsin Stone Quality of Life questionnaire	0 to 6 months
Primary	change in patient quality of life	assess this using the validated Wisconsin Stone Quality of Life questionnaire	0 to 12 months
Primary	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
Primary	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