Living With CKD: An E-Learning Platform for Adolescents With CKD About the Disease and Its Management

NCT ID: NCT05630729

Last Updated: 2022-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-07-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

My Kidney Guru Intervention

Youth Participants with CKD will complete the 9 My Kidney Guru modules over the 6-month intervention period, at a rate of approximately one module every 2-3 weeks. Parent participants will complete the parent module within the first t2 weeks of the intervention period, and to review the remaining youth modules by the end of the trial period. Participants will complete outcomes measures within 1 month prior to beginning the intervention. Software usage data will be gathered regarding fidelity and dosage of the My Kidney Guru intervention. Within 1 month of completing the intervention period, participants will complete the same set of outcomes assessments, along with an evaluation survey of the intervention. Once post-intervention data collection has been completed and the intervention period has ended, participants will participate in a 45 minute follow up Web-Ex focus group to provide feedback on their experiences with My Kidney Guru and collect additional suggestions for improvement.

Group Type: OTHER

My Kidney Guru

Intervention Type: OTHER

My Kidney Guru is 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.

Interventions

My Kidney Guru

My Kidney Guru is 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

3-C Institute for Social Development

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Debra Childress, PHD

Role: PRINCIPAL_INVESTIGATOR

3- C Institute for Social Development, dba 3C Institute

Maria Ferris, MD, PHD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

3C Institute

Durham, North Carolina, United States

Countries

United States

Other Identifiers

R44DK108421

Identifier Type: NIH

Identifier Source: org_study_id

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