Clinical Trials Logo

Clinical Trial Summary

Leveraging a unique combination of synchronized web and mobile applications, this 3 year SBIR Phase II project will fully develop and pilot test My Kidney Guru-a program that will offer pediatric patients with CKD developmentally appropriate, interactive, and engaging instruction and practice opportunities to build knowledge and skills to manage CKD.


Clinical Trial Description

Chronic kidney disease (CKD) is a progressive condition, characterized by an irreversible deterioration of renal function that gradually progresses to end-stage renal disease, requiring dialysis or kidney transplant. CKD and its co-morbidities (e.g., hypertension, anemia, acidosis, and metabolic bone disease) require strict treatment adherence to halt progression and improve outcomes. Unfortunately, the majority of pediatric patients with CKD do not adhere to their medical regimen. This non-adherence can have devastating consequences such as renal failure, kidney transplant rejection, and even death. Research underscores how a lack of information or misinformation undermines adherence, and how static educational materials are not sufficient to ensure adherence to treatment. In order to optimize adherence, there is a need for educational programs to include a behavioral self-management component. Moreover, web-based tools are well accepted among CKD patients and online education has been shown to significantly improve health outcomes for adults with chronic illness. Leveraging a unique combination of synchronized web and mobile applications, this 3 year SBIR Phase II project will fully develop and pilot test My Kidney Guru-a program that will offer pediatric patients with CKD developmentally appropriate, interactive, and engaging instruction and practice opportunities to build knowledge and skills to manage CKD. The contextually-relevant program will include personalized tools for self-monitoring and self-management including coping strategies for managing psychological and psychosocial aspects of a chronic condition. The proposed project will accomplish three specific aims: (1) Fully develop the program, including nine modules, using an iterative user-centered development-testing-revision process to ensure the software achieves optimal usability for intended end users. (2) Conduct a pilot efficacy study to assess the program's impact for improving adolescents' CKD and self-management knowledge, treatment adherence, transition readiness, self-management skills, self-efficacy, and quality of life. Adolescents with CKD will complete the nine modules over a 6-month intervention period. Parents of adolescents will review the parent module at the beginning of the trial and the youth modules at the end of the trial. Investigators expect adolescents to report significant improvements in all areas. Lastly, investigators will (3) prepare the product for commercialization by conducting focus groups with healthcare providers to review the program and gather feedback regarding implementation in healthcare delivery settings. In preparation for Phase III commercial launch, investigators will finalize revisions and reporting functions, and integrate e-commerce functions into the website. The proposed My Kidney Guru program will directly address the need for innovative solutions to effectively increase treatment adherence using a dynamic education and self-management program designed specifically to meet the needs of adolescents with CKD. Greater adherence and self-management skill will translate into significant benefits in the well-being of these youth, including lower risk for medical complications and mortality. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05630729
Study type Interventional
Source 3-C Institute for Social Development
Contact
Status Completed
Phase N/A
Start date September 1, 2021
Completion date July 31, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT06386172 - Electronic Decision-support System to Improve Detection and Care of Patients With Chronic Kidney Disease in Stockholm N/A
Recruiting NCT04910867 - APOL1 Genetic Testing Program for Living Donors N/A
Completed NCT03434145 - Changes of Ocular Structures After Hemodialysis in Patients With Chronic Kidney Diseases N/A
Recruiting NCT04984226 - Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD Phase 2
Active, not recruiting NCT05887817 - Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR) Phase 4
Recruiting NCT05318196 - Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases
Terminated NCT05022329 - COVID-19 Vaccine Boosters in Patients With CKD Phase 2/Phase 3
Not yet recruiting NCT04925661 - HEC53856 Phase Ib Study in Patients With Non-dialysis Renal Anemia Phase 1
Recruiting NCT04961164 - Resistant Starch Prebiotic Effects in Chronic Kidney Disease N/A
Completed NCT05015647 - Low Protein Diet in CKD Patients at Risk of Malnutrition N/A
Completed NCT03426787 - Helping Empower Liver and Kidney Patients N/A
Recruiting NCT06094231 - Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study N/A
Completed NCT04363554 - The Kidneys Ability to Concentrate and Dilute Urine in Patients With Autosomal Dominant Polycystic Kidney Disease N/A
Recruiting NCT04831021 - Pre- or Per-dialytic Physical Exercise : a Cardioprotective Role? N/A
Terminated NCT04877847 - Multi-Center Trial Utilizing Low Frequency Ultrasound in the Prevention of Post-Contrast Acute Kidney Injury N/A
Recruiting NCT04422652 - Combination of Novel Therapies for CKD Comorbid Depression Phase 2
Completed NCT05055362 - Effect a Honey, Spice-blended Baked Good Has on Salivary Inflammation Markers in Adults: a Pilot Study N/A
Not yet recruiting NCT06330480 - Check@Home: General Population Screening for Early Detection of Atrial Fibrillation and Chronic Kidney Disease N/A
Recruiting NCT03176862 - Left Ventricular Fibrosis in Chronic Kidney Disease N/A
Terminated NCT02539680 - Intestinal Phosphate Transporter Expression in CKD Patients N/A