Chronic Kidney Diseases Clinical Trial
— CKD DelpOfficial title:
Living With CKD: An E-Learning Platform for Adolescents With CKD About the Disease and Its Management
Verified date | November 2022 |
Source | 3-C Institute for Social Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
United States | 3C Institute | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
3-C Institute for Social Development | University of North Carolina, Chapel Hill |
United States,
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 |
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