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

NCT05630729 | Completed

• 1 other identifier: R44DK108421
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change from Baseline Beliefs about Dietary Compliance scale at 6 months

  6 months apart, as pre- and post-tests

• Change from Baseline Chronic Kidney Disease Self-Efficacy Instrument at 6 months

  6 months apart, as pre- and post-tests

• Change from Baseline Self-Efficacy for Managing Chronic Disease Scale at 6 months

  6 months apart, as pre- and post-tests

• Change from Baseline Illness Perception Questionnaire-Revised at 6 months

  6 months apart, as pre- and post-tests

• Change from Baseline Center for Epidemiologic Studies Depression Scale at 6 months

  6 months apart, as pre- and post-tests

Study Arms (1)

My Kidney Guru Intervention

OTHER

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.

Other: My Kidney Guru

Interventions

My Kidney Guru 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.

My Kidney Guru Intervention

Eligibility Criteria

• Age: 13 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• 3-C Institute for Social Development: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (2)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

3C Institute

Durham, North Carolina, 27713, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Debra Childress, PHD

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

  PRINCIPAL INVESTIGATOR

• Maria Ferris, MD, PHD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: November 30, 2022
• Study Start: September 1, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)