Mobile app to manage swelling in kidney patients
Diuretic Tuner Clinical Decision Support Mobile Device Application for Diuretic Titration in Hypervolemic States
This study tests a mobile app that helps kidney patients manage swelling by adjusting their diuretic medication and tracking their daily health data.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT04759274 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a mobile application designed to assist patients with kidney issues in managing body swelling through diuretic medication adjustments. Participants will receive the app and training on its use, requiring them to log daily blood pressure and weight. The app will provide personalized guidance based on their health data and will track medication compliance. The study will last for 90 days, with periodic blood tests and a final survey to assess outcomes.
Who should consider this trial
Good fit: Ideal candidates include individuals with nephrotic syndrome or stage 4 to 5 chronic kidney disease who exhibit signs of hypervolemia.
Not a fit: Patients with severe electrolyte imbalances or those unable to monitor their weight and blood pressure at home may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management of edema and fluid retention in patients with chronic kidney diseases.
How similar studies have performed: While this approach is innovative, similar studies utilizing mobile health applications for chronic disease management have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Dallas, Texas
- University of Texas Southwestern — Dallas, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Kamalanathan K Sambandam, M.D.
- Email: ksambandam@utsouthwestern.edu
- Phone: 214-645-6190
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.