Diuretic Tuner Clinical Decision Support (NCT04759274) | Clinical Trial Compass
RecruitingNot Applicable
Diuretic Tuner Clinical Decision Support
United States30 participantsStarted 2023-11-20
Plain-language summary
This purpose of this study is to determine the effectiveness of a mobile phone application in helping to control body swelling in patients with kidney problems. The application will help in the day to day adjustments in diuretic medication dosing.
Participants in this study will have an application loaded on to their mobile phone by the study team and be taught how to use it over a 2 hour visit. Participants will need to check their blood pressure and weight daily and enter this information into the mobile phone application every day. Participants will need to follow daily instructions in their medication dosing provided by the application. There will be periodic blood testing. This will happen at 2 weeks, 90 days, and up to 4 other times if necessary. At the end of the study there is a 2 hour study visit during which participants will answer a survey. The total length of the study is 90 days.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The presence of nephrotic range proteinuria (\> 3 g/d proteinuria by 24hr urine protein, 24hr urine albumin, spot urine protein/creatinine ratio, or spot urine albumin/creatinine ratio) or stage 4 or 5 chronic kidney disease (estimated glomerular filtration rate \< 30 mL/min/1.73 m2 by Modification of Diet in Renal Disease equation) PLUS
* Clinical signs of hypervolemia present (lower extremity edema, ascites, or pleural effusions) with an estimated dry weight (defined as edema-free weight without orthostatic hypotension) 5 lbs less than enrollment body weight
Exclusion Criteria:
* Weight \< 100 lbs or \> 300 lbs.
* Autonomic insufficiency resulting in orthostatic hypotension at screening
* Hypokalemia at enrollment (defined as serum potassium \< 3.5 mmol/L)
* Moderate to severe hyponatremia at enrollment (defined as serum sodium \< 130 mmol/L)
* Serum creatinine \> 6 mg/dL or \> 1.5 times baseline
* Patients who are unable or unwilling to measure their home blood pressures and weights
* Patients without a working phone number and smart phone device
* Expectation that the patient will require dialysis initiation within \< 3 months
* Expected lifespan of \< 6 months
* The presence of a medical condition that would interfere with effectively using the Diuretic Tuner (dementia, illiteracy, or blindness)
* Pregnant patients
* Prisoners
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean time to the attainment of dry weight
Timeframe: 90 days
2
90 day weight variability
Timeframe: 90 days
Trial details
NCT IDNCT04759274
SponsorUniversity of Texas Southwestern Medical Center