Clinical trial NCT05630729: Living With CKD: An E-Learning Platform for Adolescents With CKD About the Disease and Its Management
Official title: Living With CKD: An E-Learning Platform for Adolescents With CKD About the Disease and Its Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Chronic Kidney Disease stage3
Chronic Kidney Disease stage4
Chronic Kidney Disease Stage V
Chronic Kidney Disease Stage 5
Chronic Kidney Disease Stage 2
Chronic Kidney Disease, Stage I
Chronic Kidney Disease, Stage IV (Severe)
Pediatric Kidney Disease
Keywords: Chronic Kidney Disease
Disease Self-Management
Adolescent Health
Lead sponsor: 3-C Institute for Social Development
Sponsor class: INDUSTRY
Collaborators: name: University of North Carolina, Chapel Hill
First posted: 2022-11-30
Enrollment: 67
Sex: ALL
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 13-25 years old
* Been in Stage 1-5 CKD for at least 3 months or \<1 year post transplant
* English Language fluency
* No significant intellectual or developmental delays

Exclusion Criteria:

* Adolescents who participated in the Phase I feasibility testing or Phase II usability testing will be excluded from the pilot test due to their familiarity with the proposed product.

Primary outcomes:
measure: Change from Baseline Self-Management and Transition to Adulthood Treatment Questionnaire at 6 months
timeFrame: 6 months apart, as pre- and post-tests
Secondary outcomes:
measure: Change from Baseline Beliefs about Dietary Compliance scale at 6 months
timeFrame: 6 months apart, as pre- and post-tests
measure: Change from Baseline Chronic Kidney Disease Self-Efficacy Instrument at 6 months
timeFrame: 6 months apart, as pre- and post-tests
measure: Change from Baseline Self-Efficacy for Managing Chronic Disease Scale at 6 months
timeFrame: 6 months apart, as pre- and post-tests
measure: Change from Baseline Illness Perception Questionnaire-Revised at 6 months
timeFrame: 6 months apart, as pre- and post-tests
measure: Change from Baseline Center for Epidemiologic Studies Depression Scale at 6 months
timeFrame: 6 months apart, as pre- and post-tests
measure: Change from Baseline Kidney Disease and Quality of Life-Short Form at 6 months
timeFrame: 6 months apart, as pre- and post-tests
measure: Change from Baseline Knowledge of My Kidney Guru at 6 months
timeFrame: 6 months apart, as pre- and post-tests
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: 3C Institute
state: North Carolina
Study officials:
affiliation: 3- C Institute for Social Development, dba 3C Institute
name: Debra Childress, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Maria Ferris, MD, PHD, MPH
role: PRINCIPAL_INVESTIGATOR
References: