Evolution of Physical Frailty and Patient-Reported Outcome Measures in Kidney Transplant Candidates: A Mixed-Methods Longitudinal Study Protocol

Summary

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.

Conditions

• Kidney Failure, Chronic
• Frailty
• Quality of Life
• Kidney Transplantation
• Patient Reported Outcome Measures

Interventions

OTHER

Longitudinal Frailty Assessment

Systematic 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.

OTHER

Electronic Patient-Reported Outcome Measures (ePROMs)

Implementation 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.

Sponsors & Collaborators

• Hospital del Mar

  lead OTHER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-31

Primary Completion

2028-07-31

Completion

2028-07-31