SBIR-STTR Award

Chronic kidney disease (CKD) is a progressive condition, characterized by an irreversible deterioration of renal function that gradually progresses to end-stage renal disease (ESRD), requiring dialysis or kidney transplant. CKD and its co-morbidities (e.g. hypertension, anemia, acidosis, metabolic bone disease), require strict treatment adherence to halt progression and improve outcomes. Adolescence is a critical transition time when youth take on primary responsibility for management of their illness and parental supervision drops off. However, disease knowledge (understanding of the disease and its consequences) and self-management skills of adolescents with CKD have been demonstrated to be poor, representing major impediments to self- management, inconsistent commitment to treatment regimens, and suboptimal health outcomes. Adherence to medical treatment among pediatric patients with CKD/ESRD is multifactorial and a major challenge, particularly in the adolescent and young adult populations. CKD can be silent, and the consequences of non-adherence are not immediately noticeable to patients. This non-adherence has devastating impacts. The 10-year survival rate for adolescent onset ESRD is > 80 percent and, despite medical advances, kidney transplant loss in adolescents exceeds that of any other population. In addition, adolescents receiving their first renal transplant between ages 14 and 16 have the highest risk of graft loss and worse outcomes in follow-ups post-transplant. Reviews of adherence studies for a wide array of chronic illness have underscored the influential role information plays in determining adherence. While education is essential, the literature underscores that static educational materials are not sufficient to ensure adherence to treatment. In fact, a review of adherence studies indicates that adding a behavioral self-management component to an educational program optimizes adherence. 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. Given this, technology-based training has the potential to both engage adolescents and support education and self-management skills tailored for individual treatment regimens. This 6-month SBIR Phase I project includes three specific aims: (1) develop the My Kidney Guru prototype; (2) conduct prototype usability and feasibility testing with adolescents with CKD, healthcare providers (i.e., physicians, nurses, dieticians) of adolescents with CKD, and parents of youth with CKD; and (3) prepare for Phase II full development. 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 health and well-being of these youth, including lower risk for medical complications and mortality, and healthcare cost reductions.

Public Health Relevance Statement:


Public Health Relevance:
Disease knowledge and self-management skills of adolescents with CKD have been demonstrated to be poor, representing major impediments to self-management, inconsistent commitment to treatment regimens, and suboptimal health outcomes. Increasing disease- and treatment-related knowledge is an essential component of any intervention to improve treatment adherence and support the successful transition to adult self- management. In response to this problem, this SBIR project aims to develop a web-accessible dynamic education and self-management program designed specifically to meet the needs of adolescents with CKD.

Project Terms:
Acidosis; Address; Adherence; Adolescence; Adolescent; Adolescent and Young Adult; Adult; Age; aged; Anemia; base; Behavioral; Businesses; Childhood; Chronic Disease; Chronic Kidney Failure; Cognitive; Collaborations; Comorbidity; Computer software; course development; Data; design; Deterioration; Development; Development Plans; Dialysis procedure; Disease; Drops; E-learning; editorial; Education; Educational Materials; End stage renal failure; Ensure; Evaluation; Feedback; field study; Foundations; Goals; Health; Health Care Costs; Health Personnel; Healthcare; high risk; Home environment; Housing; Hypertension; improved; improved outcome; Individual; Influentials; innovation; Instruction; Interdisciplinary Study; Internet; Intervention; Kidney; Kidney Transplantation; Knowledge; Learning; Life; literacy; Literature; Medical; medical complication; meetings; Metabolic Bone Diseases; Methods; Modality; mortality; Nurses; Online Systems; Outcome; Parents; Patient-Focused Outcomes; Patients; pediatric patients; Personal Satisfaction; Phase; Physicians; Play; Population; product development; programs; prototype; public health relevance; Recruitment Activity; Renal function; Research; Research Infrastructure; Respondent; response; Risk; Role; Self Management; Sensory; skills; Small Business Innovation Research Grant; Subgroup; Supervision; Survival Rate; Technology; Testing; Time; tool; Training; Training Activity; Translating; Transplantation; treatment adherence; Treatment Protocols; usability; web-accessible; webinar; Work; Youth

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. We expect adolescents to report significant improvements in all areas. Lastly, we 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, we 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.

Thesaurus Terms:
Acidosis; Address; Adherence; Adolescent; Adolescent Patient; Adult; Age; Anemia; Area; Arm; Awareness; Base; Behavioral; Cessation Of Life; Childhood; Chronic; Chronic Disease; Chronic Kidney Failure; Commercial Application; Commercialization; Comorbidity; Computer Software; Coping; Course Development; Data; Data Analyses; Design; Deterioration; Development; Developmental Disease; Dialysis Procedure; Disease; Disease Management; E-Commerce; E-Learning; Education; Educational Materials; Efficacy Study; End Stage Renal Failure; Ensure; Evidence Base; Experience; Family; Feedback; Focus Groups; Foundations; Goals; Graft Rejection; Health; Health Care Delivery; Health Personnel; Healthcare; Hypertension; Improved; Improved Outcome; Independent Self Care; Information Resources Management; Innovation; Intervention; Kidney; Kidney Failure; Kidney Transplantation; Knowledge; Literacy; Literature; Manuscripts; Medical; Medical Complication; Metabolic Bone Diseases; Misinformation; Mobile Application; Monitor; Mortality; Nonprofit Organizations; Outcome; Parents; Participant; Patient Education; Patient Recruitments; Patient-Focused Outcomes; Patients; Pediatric Patients; Personal Satisfaction; Phase; Post Intervention; Preparation; Process; Program Reviews; Programs; Provider; Psychologic; Psychological Stress; Psychosocial; Psychosocial Stress; Quality Of Life; Readiness; Recruit; Regimen; Renal Function; Reporting; Research; Risk; Self Care; Self Efficacy; Self Management; Self Perception; Self-Management Program; Skills; Small Business Innovation Research Grant; Stress; Teaching Method; Technology; Teenagers; Testing; Time; Tool; Translating; Treatment Adherence; Usability; Web App; Web Site; Web-Based Tool; Youth;