This study looks at how the physical and emotional health of people changes while they wait for a kidney transplant. Waiting for an organ can take a long time. During this period, some patients become "frail." This means they lose strength and are at a higher risk for health problems.
The main goal is to follow these patients over time to better understand their needs. Researchers will use a mobile application to collect Patient-Reported Outcome Measures (PROMs) directly from patients about how they feel and their quality of life. The study will also include personal interviews to learn about the patients' experiences and any difficulties they face when using technology.
The results of this study will help to: • Identify early which patients are losing strength or health. • Improve the support that nurses provide during the transplant waiting period. • Make sure that digital health tools are easy for everyone to use.
In short, this work aims to help patients reach the day of their surgery in the best possible condition.
Patients aged 18 years or older.
Diagnosed with Stage 5 chronic kidney disease (CKD).
Currently undergoing clinical evaluation for or actively listed on the deceased-donor kidney transplant waiting list at Hospital del Mar (Barcelona).
Cognitive and physical ability to understand and provide written informed consent.
Severe cognitive impairment or active psychiatric disorders that prevent the reliable completion of questionnaires or physical tests.
Major physical disability that precludes the objective assessment of gait speed or handgrip strength (e.g., bilateral lower limb amputation or severe dominant hand deformity).
Acute medical illness requiring hospitalization at the time of enrolment.
Total language barrier that prevents understanding the study components or the qualitative interview.
The study population consists of adult patients with End-Stage Renal Disease (ESRD), also classified as Stage 5 chronic kidney disease, managed at the Nephrology Department of Hospital del Mar (Barcelona). This clinical cohort includes patients currently receiving renal replacement therapy (either maintenance haemodialysis or peritoneal dialysis) as well as individuals in the pre-dialysis stage who have been formally referred for comprehensive kidney transplant evaluation. The target population is characterized by a high burden of medical comorbidity and varying degrees of physical frailty associated with chronic uraemia and long-term dialysis treatment.
Cohort
Prospective
Longitudinal Frailty Assessment
Other interventionSystematic multidimensional assessment of physical frailty conducted by an Advanced Practice Nurse (APN) specialized in nephrology. The evaluation encompasses the following components: * Fried Phenotype: Objective measurement of 5 criteria: unintended weight loss, self-reported exhaustion, physical activity level, gait speed (over 4 meters), and handgrip strength (using a calibrated hydraulic dynamometer). * Clinical Frailty Scale (CFS): Global clinical judgment score based on the patient's overall fitness and functional independence. * Short Physical Performance Battery (SPPB): Standardized test battery to objectively assess balance, gait speed, and lower limb strength through timed chair stands. Frequency: Assessments will be performed at baseline and every 6 months (+/- 1 month) throughout the patient's presence on the kidney transplant waiting list. Standardized protocols ensure data reproducibility.
Electronic Patient-Reported Outcome Measures (ePROMs)
Other interventionImplementation of a digital health strategy to monitor patient-reported outcomes throughout the kidney transplant waiting list period. Core Instrument: Participants complete the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 v2.0 questionnaire, assessing 7 health domains: physical function, anxiety, depression, fatigue, sleep disturbance, social roles/activities, pain interference, and pain intensity. Procedure: • Data Collection: Administered via a secure electronic Patient-Reported Outcome Measures (ePROMs) digital platform accessible via smartphone, tablet, or computer. • Frequency: Data collected at baseline and every 6 months, coinciding with physical frailty assessments. • Support: An Advanced Practice Nurse (APN) provides technical onboarding and follows up on non-compliance to address the digital divide. This observational strategy aims to capture the patient's subjective health status.
Change in Frailty Status (Fried Phenotype)
Change in frailty status over time assessed using the Fried Frailty Phenotype cumulative score, with a total score ranging from 0 to 5 points, where higher scores indicate greater physical frailty. Frailty status categories are defined as: Non-frail: 0 points Pre-frail: 1-2 points Frail: 3-5 points The outcome measure will assess longitudinal changes in the cumulative frailty score and frailty category during the patient's time on the kidney transplant waiting list.
Change in Patient-Reported Outcome Measures (PROMs)
Change over time in health-related quality of life measured using the Patient-Reported Outcomes Measurement Information System-29 version 2.0 (PROMIS-29 v2.0). PROMIS-29 domain scores are reported as standardized T-scores ranging from approximately 20 to 80, where 50 represents the population mean and 10 the standard deviation. Higher scores indicate more of the concept being measured: Higher physical function and social participation scores indicate better functioning. Higher anxiety, depression, fatigue, sleep disturbance, and pain interference scores indicate worse symptoms. Each PROMIS domain score will be analyzed independently according to PROMIS scoring guidelines.
Incidence of Clinical Transitions on the Waiting List
Incidence and time-to-event of major clinical transitions affecting transplant waiting list status, including kidney transplantation, temporary or permanent removal from the waiting list, and all-cause mortality.
Digital Tool Usability and Implementation Barriers
Assessment of the feasibility and usability of the electronic Patient-Reported Outcome Measures (ePROMs) platform during longitudinal follow-up. Feasibility will be evaluated using questionnaire completion and adherence rates across the study period. Implementation barriers related to technology use and digital access will be identified and categorized through qualitative documentation obtained during Advanced Practice Nurse (APN) follow-up sessions.
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