John C Sieverdes1, Matthew Price2, Kenneth J Ruggiero3, Prabhakar K Baliga4, Kenneth D Chavin5, Brenda Brunner-Jackson6, Sachin Patel7, Frank A Treiber8. 1. Medical University of South Carolina, College of Nursing, 99 Jonathan Lucas St., Charleston, SC 29425-1600, USA. Electronic address: sieverde@musc.edu. 2. University of Vermont, College of Arts and Sciences, Department of Psychological Science, John Dewey Hall, Rm 248 2 Colchester Avenue, Burlington, VT 05405-0134, USA. Electronic address: matthew.price@uvm.edu. 3. Medical University of South Carolina, College of Nursing, 99 Jonathan Lucas St., Charleston, SC 29425-1600, USA. Electronic address: ruggierk@musc.edu. 4. Medical University of South Carolina, College of Medicine, 96 Jonathan Lucas St., Charleston, SC 29425-1600, USA. Electronic address: baligap@musc.edu. 5. Medical University of South Carolina, College of Medicine, 96 Jonathan Lucas St., Charleston, SC 29425-1600, USA; Case Western Reserve University School of Medicine, Department of Surgery-Transplant, 11100 Euclid Ave, Cleveland, OH 44106, USA. Electronic address: kenneth.chavin@uhhospitals.org. 6. Medical University of South Carolina, College of Nursing, 99 Jonathan Lucas St., Charleston, SC 29425-1600, USA. Electronic address: brunnerj@musc.edu. 7. Medical University of South Carolina, College of Nursing, 99 Jonathan Lucas St., Charleston, SC 29425-1600, USA. Electronic address: patelsk@musc.edu. 8. Medical University of South Carolina, College of Nursing, 99 Jonathan Lucas St., Charleston, SC 29425-1600, USA; Medical University of South Carolina, College of Medicine, 96 Jonathan Lucas St., Charleston, SC 29425-1600, USA. Electronic address: treiberf@musc.edu.
Abstract
PURPOSE: To describe the rationale, methodology, design, and interventional approach of a mobile health education program designed for African Americans with end stage renal disease (ESRD) to increase knowledge and self-efficacy to approach others about their need for a living donor kidney transplant (LDKT). METHODS: The Living Organ Video Educated Donors (LOVED) program is a theory-guided iterative designed, mixed methods study incorporating three phases: 1) a formative evaluation using focus groups to develop program content and approach; 2) a 2-month proof of concept trial (n=27) to primarily investigate acceptability, tolerability and investigate increases of LDKT knowledge and self-efficacy; and 3) a 6-month, 2-arm, 60-person feasibility randomized control trial (RCT) to primarily investigate increases in LDKT knowledge and self-efficacy, and secondarily, to increase the number of living donor inquiries, medical evaluations, and LDKTs. The 8-week LOVED program includes an interactive web-based app delivered on 10″ tablet computer incorporating weekly interactive video education modules, weekly group video chat sessions with an African American navigator who has had LDKT and other group interactions for support and improve strategies to promote their need for a kidney. RESULTS: Phase 1 and 2 have been completed and the program is currently enrolling for the feasibility RCT. Phase 2 experienced 100% retention rates with 91% adherence completing the video modules and 88% minimum adherence to the video chat sessions. CONCLUSIONS: We are in the early stages of an RCT to evaluate the LOVED program; to date, we have found high tolerability reported from Phase 2.
RCT Entities:
PURPOSE: To describe the rationale, methodology, design, and interventional approach of a mobile health education program designed for African Americans with end stage renal disease (ESRD) to increase knowledge and self-efficacy to approach others about their need for a living donor kidney transplant (LDKT). METHODS: The Living Organ Video Educated Donors (LOVED) program is a theory-guided iterative designed, mixed methods study incorporating three phases: 1) a formative evaluation using focus groups to develop program content and approach; 2) a 2-month proof of concept trial (n=27) to primarily investigate acceptability, tolerability and investigate increases of LDKT knowledge and self-efficacy; and 3) a 6-month, 2-arm, 60-person feasibility randomized control trial (RCT) to primarily investigate increases in LDKT knowledge and self-efficacy, and secondarily, to increase the number of living donor inquiries, medical evaluations, and LDKTs. The 8-week LOVED program includes an interactive web-based app delivered on 10″ tablet computer incorporating weekly interactive video education modules, weekly group video chat sessions with an African American navigator who has had LDKT and other group interactions for support and improve strategies to promote their need for a kidney. RESULTS: Phase 1 and 2 have been completed and the program is currently enrolling for the feasibility RCT. Phase 2 experienced 100% retention rates with 91% adherence completing the video modules and 88% minimum adherence to the video chat sessions. CONCLUSIONS: We are in the early stages of an RCT to evaluate the LOVED program; to date, we have found high tolerability reported from Phase 2.
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