Stone, KidneyNCT05389982
Mobile Health Platform for Surveillance of Kidney Stone
A study testing mHealth (GetWell) in people with Stone, Kidney, run by Northwestern University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stone, Kidney
- What is being tested?
- mHealth (GetWell)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Usage of a Mobile Health Platform for Surveillance of Kidney Stone Formers
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.
- Conditions
- Stone, Kidney
- Being tested
- mHealth (GetWell), Standard Care
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth (GetWell)Other
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 CareOther
Office based pathway
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Placebo comparator | Not described Receives: Other: Standard Care |
| standard care + mHealth (GetWell) | Active comparator | Not described Receives: Other: mHealth (GetWell); Other: Standard Care |
| mHealth (GetWell) | Active comparator | Not described Receives: Other: mHealth (GetWell) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in patient quality of life
assess this using the validated Wisconsin Stone Quality of Life questionnaire
Measured: 0 to 6 months
change in patient quality of life
assess this using the validated Wisconsin Stone Quality of Life questionnaire
Measured: 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"),
Measured: 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"),
Measured: 0 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start1 Aug 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Why it stopped: The study was stopped early due to lack of recruitment/difficulty meeting recruitment goal.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stone, KidneyStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Krambeck, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389982
- Sponsor's protocol ID
- STU00216640
- Status last verified
- Mar 2024
- First submitted
- 6 May 2022
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usage of a Mobile Health Platform for Surveillance of Kidney Stone Formers
- ClinicalTrials.gov ID
- NCT05389982
- Acronym / sponsor ID
- STU00216640
- Conditions
- Stone, Kidney
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped early due to lack of recruitment/difficulty meeting recruitment goal.
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Placebo comparator | Other: Standard Care |
| standard care + mHealth (GetWell) | Active comparator | Other: mHealth (GetWell), Other: Standard Care |
| mHealth (GetWell) | Active comparator | Other: mHealth (GetWell) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | mHealth (GetWell), standard care + mHealth (GetWell) |
| Standard CareOffice based pathway | Other | Standard Care, standard care + mHealth (GetWell) |
Primary outcome
change in patient quality of life
Time frame: 0 to 6 months
assess this using the validated Wisconsin Stone Quality of Life questionnaire
change in patient quality of life
Time frame: 0 to 12 months
assess this using the validated Wisconsin Stone Quality of Life questionnaire
Change in overall stone health scale
Time frame: 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"),
Change in overall stone health scale
Time frame: 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"),
Results and safety
The study was stopped early (reason given: The study was stopped early due to lack of recruitment/difficulty meeting recruitment goal.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth (GetWell) in people with Stone, Kidney, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was stopped early due to lack of recruitment/difficulty meeting recruitment goal.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in patient quality of life (time frame: 0 to 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.