- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05630729
Living With CKD: An E-Learning Platform for Adolescents With CKD About the Disease and Its Management (CKD Delp)
November 27, 2022 updated by: 3-C Institute for Social Development
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
67
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina at Chapel Hill
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Durham, North Carolina, United States, 27713
- 3C Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 25 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Self-Management and Transition to Adulthood Treatment Questionnaire at 6 months
Time Frame: 6 months apart, as pre- and post-tests
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Beliefs about Dietary Compliance scale at 6 months
Time Frame: 6 months apart, as pre- and post-tests
|
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.
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6 months apart, as pre- and post-tests
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Change from Baseline Chronic Kidney Disease Self-Efficacy Instrument at 6 months
Time Frame: 6 months apart, as pre- and post-tests
|
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.
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6 months apart, as pre- and post-tests
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Change from Baseline Self-Efficacy for Managing Chronic Disease Scale at 6 months
Time Frame: 6 months apart, as pre- and post-tests
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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.
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6 months apart, as pre- and post-tests
|
Change from Baseline Illness Perception Questionnaire-Revised at 6 months
Time Frame: 6 months apart, as pre- and post-tests
|
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.
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6 months apart, as pre- and post-tests
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Change from Baseline Center for Epidemiologic Studies Depression Scale at 6 months
Time Frame: 6 months apart, as pre- and post-tests
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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.
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6 months apart, as pre- and post-tests
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Change from Baseline Kidney Disease and Quality of Life-Short Form at 6 months
Time Frame: 6 months apart, as pre- and post-tests
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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.
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6 months apart, as pre- and post-tests
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Change from Baseline Knowledge of My Kidney Guru at 6 months
Time Frame: 6 months apart, as pre- and post-tests
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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.
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6 months apart, as pre- and post-tests
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2021
Primary Completion (Actual)
July 31, 2022
Study Completion (Actual)
July 31, 2022
Study Registration Dates
First Submitted
June 15, 2020
First Submitted That Met QC Criteria
November 27, 2022
First Posted (Actual)
November 30, 2022
Study Record Updates
Last Update Posted (Actual)
November 30, 2022
Last Update Submitted That Met QC Criteria
November 27, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R44DK108421 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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