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Mobile Health Platform for Surveillance of Kidney Stone

Sponsor
Northwestern University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05389982
Collaborator
(none)
150
Enrollment
3
Arms
36
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: mHealth (GetWell)
  • Other: Standard Care
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Usage of a Mobile Health Platform for Surveillance of Kidney Stone Formers
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Standard Care

Other: Standard Care
Office based pathway
Active Comparator: standard care + mHealth (GetWell)

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.

Other: Standard Care
Office based pathway
Active Comparator: mHealth (GetWell)

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.

Outcome Measures

Primary Outcome Measures

  1. change in patient quality of life [0 to 6 months]

    assess this using the validated Wisconsin Stone Quality of Life questionnaire

  2. change in patient quality of life [0 to 12 months]

    assess this using the validated Wisconsin Stone Quality of Life questionnaire

  3. Change in overall stone health scale [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"),

  4. Change in overall stone health scale [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"),

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Northwestern University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amy Krambeck, Director of the Endourology/Stone Division, Northwestern University
ClinicalTrials.gov Identifier:
NCT05389982
Other Study ID Numbers:
  • STU00216640
First Posted:
May 25, 2022
Last Update Posted:
May 25, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Kidney Calculi
Nephrolithiasis

Study Results

No Results Posted as of May 25, 2022