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

Chronic Kidney Diseases Clinical Trial

— CKD Delp  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05630729
• Other study ID #: R44DK108421
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: November 2022
• Source: 3-C Institute for Social Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease Stage 2
• Chronic Kidney Disease Stage 5
• Chronic Kidney Disease Stage V
• Chronic Kidney Disease stage3
• Chronic Kidney Disease stage4
• Chronic Kidney Disease, Stage IV (Severe)
• Chronic Kidney Diseases
• Kidney Diseases
• Pediatric Kidney Disease
• Renal Insufficiency, Chronic

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	3C Institute	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
3-C Institute for Social Development	University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Self-Management and Transition to Adulthood Treatment Questionnaire at 6 months	Both parents and adolescents will complete this 18-item measure, rating the extent to which youth are ready to transition to self-care and manage their health-related needs independently. Items assess adolescents' independence in scheduling doctor's appointments, remembering to take medication, finding answers to health-related questions, knowledge of their condition, and how easy/difficult these tasks are for the youth. Responses range from 0 (Never, Very Hard, or Nothing) to 5 (Always, Very Easy, or A Lot). Total scores range from 0 to 90. Higher scores reflect better outcomes.	6 months apart, as pre- and post-tests
Secondary	Change from Baseline Beliefs about Dietary Compliance scale at 6 months	This modified measure contains 9 items, on which adolescents and their parents report on their perceptions of the benefits and barriers of adherence to the condition treatment regimen. Responses range from 0 (strongly disagree) to 4 (strongly agree). Total scores range from 0 to 36. Higher scores reflect greater perceived benefits.	6 months apart, as pre- and post-tests
Secondary	Change from Baseline Chronic Kidney Disease Self-Efficacy Instrument at 6 months	Adolescents will complete this 25-item reporting their self-confidence in managing their condition, including self-confidence in (a) managing the disease autonomously, (b) integrating treatment requirements to fit new situations or social activities, (c) finding solutions to CKD-related problems, and (d) finding social support when needing help. Responses range from 1 (not at all confident) to 10 (totally confident). Total scores range from 25 to 250. Higher scores reflect improved outcomes.	6 months apart, as pre- and post-tests
Secondary	Change from Baseline Self-Efficacy for Managing Chronic Disease Scale at 6 months	Adolescents will report on condition self-management by responding to 6 items reporting their confidence and ability to observe and understand symptoms. Responses range from 0 (not at all confident) to 10 (totally confident). Total scores range from 0 to 60. Higher scores reflect improved outcomes.	6 months apart, as pre- and post-tests
Secondary	Change from Baseline Illness Perception Questionnaire-Revised at 6 months	Adolescent participants report their perceptions of the severity of their condition. These items assess the extent to which a patient believes their condition to be serious and to have major consequences on his/her life. Responses range from 1 (strongly disagree) to 5 (strongly agree). Total scores range from 6 to 30. Higher scores reflect worse outcomes.	6 months apart, as pre- and post-tests
Secondary	Change from Baseline Center for Epidemiologic Studies Depression Scale at 6 months	Adolescent participants respond to the this 20-item measure rating how often they experienced symptoms associated with depression over the past week, including poor sleep, loss of appetite, and loneliness. Responses range from 1 (rarely) to 4 (all of the time). Total scores range from 20 to 80. Higher scores reflect worse outcomes.	6 months apart, as pre- and post-tests
Secondary	Change from Baseline Kidney Disease and Quality of Life-Short Form at 6 months	Adolescent participants will complete a subset of 19 items modified to be more general and applicable to any medical condition. These items comprise subscales that assess patients' symptoms, burden of condition in interfering with life, cognitive functioning, social support, and difficulty sleeping. Items are scored based on the configuration of the item (e.g., frequency of behavior, 1-non to 6-very severe). Total scores range from 15-91. Higher scores indicate worse outcomes.	6 months apart, as pre- and post-tests
Secondary	Change from Baseline Knowledge of My Kidney Guru at 6 months	On this measure, both parent and adolescent participants complete a 30 item multiple choice questionnaire designed to assess their knowledge of information learned in the My Kidney Guru program. Each item is worth 0 to 1 point. Total scores range from 0 to 20. Higher scores reflect better outcomes.	6 months apart, as pre- and post-tests