Chronic Kidney DiseasesCKD DelpNCT05630729
Living With CKD: An E-Learning Platform for Adolescents With CKD About the Disease and Its Management
A study testing My Kidney Guru in people with Chronic Kidney Diseases and Chronic Kidney Disease stage3, run by 3-C Institute for Social Development at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 13 to 25 years
- Conditions the study is for
- Chronic Kidney Diseases, Chronic Kidney Disease stage3, Chronic Kidney Disease stage4
- What is being tested?
- My Kidney Guru
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2021to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
3C Institute
Durham, North Carolina, 27713
About this study
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.
Read the 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
- Being tested
- My Kidney Guru
- Keywords
- Chronic Kidney Disease, Disease Self-Management, Adolescent Health
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My Kidney GuruOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: My Kidney Guru |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months apart, as pre- and post-tests
Secondary outcomes (7)
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.
Measured: 6 months apart, as pre- and post-tests
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.
Measured: 6 months apart, as pre- and post-tests
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.
Measured: 6 months apart, as pre- and post-tests
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.
Measured: 6 months apart, as pre- and post-tests
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.
Measured: 6 months apart, as pre- and post-tests
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.
Measured: 6 months apart, as pre- and post-tests
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.
Measured: 6 months apart, as pre- and post-tests
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start1 Sep 2021
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3-C Institute for Social Development
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
- Investigators
- Debra Childress, PHD, Principal investigator, 3- C Institute for Social Development, dba 3C InstituteMaria Ferris, MD, PHD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630729
- Sponsor's protocol ID
- R44DK108421
- Acronym
- CKD Delp
- Status last verified
- Nov 2022
- First submitted
- 15 Jun 2020
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living With CKD: An E-Learning Platform for Adolescents With CKD About the Disease and Its Management
- ClinicalTrials.gov ID
- NCT05630729
- Acronym / sponsor ID
- CKD Delp / R44DK108421
- 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
- Keywords
- Chronic Kidney Disease, Disease Self-Management, Adolescent Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- 3-C Institute for Social DevelopmentIndustry (pharma, biotech, devices)
- Collaborators
- University of North Carolina, Chapel Hill
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| My Kidney Guru Intervention | Other | Other: My Kidney GuruYouth 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. |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| My Kidney GuruMy 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. | Other | My Kidney Guru Intervention |
Primary outcome
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.
7 secondary outcomes
Change from Baseline Beliefs about Dietary Compliance scale at 6 months
Time frame: 6 months apart, as pre- and post-tests
Change from Baseline Chronic Kidney Disease Self-Efficacy Instrument at 6 months
Time frame: 6 months apart, as pre- and post-tests
Change from Baseline Self-Efficacy for Managing Chronic Disease Scale at 6 months
Time frame: 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
Change from Baseline Center for Epidemiologic Studies Depression Scale at 6 months
Time frame: 6 months apart, as pre- and post-tests
Change from Baseline Kidney Disease and Quality of Life-Short Form at 6 months
Time frame: 6 months apart, as pre- and post-tests
Change from Baseline Knowledge of My Kidney Guru at 6 months
Time frame: 6 months apart, as pre- and post-tests
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra Childress, PHD principal investigator
3- C Institute for Social Development, dba 3C Institute
Maria Ferris, MD, PHD, MPH principal investigator
University of North Carolina, Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing My Kidney Guru in people with Chronic Kidney Diseases and Chronic Kidney Disease stage3, run by 3-C Institute for Social Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Self-Management and Transition to Adulthood Treatment Questionnaire at 6 months (time frame: 6 months apart, as pre- and post-tests). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.