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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05389982
Other study ID # STU00216640
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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