#250 Advancing coaching and telehealth for CKD Care: the ACT-CKD cohort study protocol

Abstract Background and Aims Chronic kidney disease (CKD) is a growing global healthcare challenge, affecting around 9 million people in Germany alone. Many patients do not receive adequate diagnostics and care, and barriers are expected to increase in the future. Furthermore, patients often lack disease knowledge and resources needed to make informed decisions about kidney-replacement therapy. The KDIGO guidelines for CKD highlight telemedicine as a potential solution to address these challenges. While early evidence highlights the promise of telehealth in CKD care, there is a clear need for further development and testing of innovative programs. Kidney+ is a novel hybrid telecoaching program designed to help CKD patients actively manage their health. The program combines telemedicine consultations—via chat, telephone or video—with a multidisciplinary care team of nurses, dietitians and patient peers. Patients receive guidance regarding healthy lifestyle habits, medication adherence, and self-sufficient decision-making regarding kidney replacement therapies. The ACT-CKD study aims to achieve three key objectives: (1) Build a detailed profile of the participants using the program. (2) Evaluate program effects regarding clinical parameters and patient-reported outcome measures. (3) Examine how participants engage with the program, their usage patterns, and their satisfaction with the telecoaching experience. Method The ACT-CKD cohort study will recruit patients with CKD attending a nephrology specialist and receiving the standard of care. Patients will access the Kidney+ program via its companion app. The study follows a longitudinal design over six months with a single-arm structure, conducting a pre/post-program analysis. To build a user profile, demographics, underlying diseases, laboratory values, and medication data will be analyzed. Evaluation of program effects will consist of clinical parameters such as blood pressure, body mass index, and laboratory changes as well as patient-reported outcome measures like quality of life (PROMIS-29), patient activation (PAM13), medication adherence (A14), lifestyle changes, disease knowledge, and preferred kidney replacement therapy. Regarding patient engagement with the program, analysis will focus on usage patterns and program satisfaction (adapted smartNTx). Based on an estimated medium effect size for most endpoints, a cohort of 100 participants has been determined as the required sample size. This calculation ensures sufficient power to evaluate the study hypotheses after six months of program participation. Results The study will follow a structured timeline, with data collection occurring at baseline and after six months of participation in the Kidney+ program. The primary analysis will focus on patient profile, program effects and usage patterns. Results will provide robust new insights into the impact and feasibility of the Kidney+ program, offering a foundation for further research and development in innovative telehealth solutions for CKD care. The findings are expected to raise further questions and open new pathways in hybrid telecoaching approaches. Regulatory approval is anticipated for Q1 2025, with recruitment planned from Q1 to Q2 2025. Results are expected by Q4 2025. Conclusion Nurse-led telecare has emerged as a promising approach for managing chronic diseases, offering significant potential for patients with CKD. However, comprehensive and well-structured programs tailored to this population with proven medical benefits remain scarce. The Kidney+ program aims to bridge this gap with an innovative, patient-centered telecoaching model designed to improve not only patient-reported outcomes but also clinically important features. The ACT-CKD study will evaluate the impact of the Kidney+ program, examining its effects on clinical and behavioral outcomes as well as user engagement. By addressing the pressing need for research into hybrid-care solutions for CKD, this study seeks to determine whether the program could serve as a cornerstone for future care models, easing the strain on an increasingly overburdened healthcare system.