Back to resultsMobile Health Platform for Surveillance of Kidney Stone
Primary Purpose
Stone, Kidney
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mHealth (GetWell)
Standard Care
Sponsored by
About this trial
This is an interventional supportive care trial for Stone, Kidney
Eligibility Criteria
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
Sites / Locations
- Northwestern UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Standard Care
standard care + mHealth (GetWell)
mHealth (GetWell)
Arm Description
Outcomes
Primary Outcome Measures
change in patient quality of life
assess this using the validated Wisconsin Stone Quality of Life questionnaire
change in patient quality of life
assess this using the validated Wisconsin Stone Quality of Life questionnaire
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"),
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"),
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05389982
Brief Title
Mobile Health Platform for Surveillance of Kidney Stone
Official Title
Usage of a Mobile Health Platform for Surveillance of Kidney Stone Formers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stone, Kidney
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard Care
Arm Type
Placebo Comparator
Arm Title
standard care + mHealth (GetWell)
Arm Type
Active Comparator
Arm Title
mHealth (GetWell)
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
mHealth (GetWell)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Care
Intervention Description
Office based pathway
Primary Outcome Measure Information:
Title
change in patient quality of life
Description
assess this using the validated Wisconsin Stone Quality of Life questionnaire
Time Frame
0 to 6 months
Title
change in patient quality of life
Description
assess this using the validated Wisconsin Stone Quality of Life questionnaire
Time Frame
0 to 12 months
Title
Change in overall stone health scale
Description
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"),
Time Frame
0 to 6 months
Title
Change in overall stone health scale
Description
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"),
Time Frame
0 to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jenny Guo
Phone
3126958146
Email
jenny.guo@northwestern.edu
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenny Guo, MD
Phone
312-695-8146
Email
jenny.guo@northwestern.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mobile Health Platform for Surveillance of Kidney Stone
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