EVOLUTION IN FRAGILITY IN PEOPLE ON THE WAITING LIST FOR A KIDNEY TRANSPLANT

NCT07607041 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2026-05-26

No results posted yet for this study

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 app to collect information 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

Intervention Description (Intervention 1: Frailty Assessment) Systematic multidimensional assessment of frailty conducted by an Advanced Practice Nurse (APN) specialized in nephrology. Components of assessment: 1. Fried Phenotype: Objective measurement of 5 criteria: unintended weight loss, self-reported exhaustion, level of physical activity, gait speed (measured over 4 meters), and handgrip strength (measured using a calibrated hydraulic dynamometer). 2. Clinical Frailty Scale (CFS): Global clinical judgment based on fitness and functional independence. 3. SPPB (Short Physical Performance Battery): To assess balance, gait, and lower limb strength (chair stands). Frequency: Assessments will be performed at baseline (enrollment) and every 6 months (+/- 1 month) throughout the duration of the patient's presence on the kidney transplant waiting list. All measurements follow standardized protocols to minimize inter-observer variability and 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 will complete the PROMIS-29 v2.0 (Patient-Reported Outcomes Measurement Information System) questionnaire. This validated tool assesses 7 key health domains: Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Roles/Activities, and Pain Interference, plus a single-item pain intensity scale. Procedure: 1. Data Collection: Administered via a secure digital platform (ePROMs) accessible via smartphone, tablet, or computer. 2. Frequency: Data will be collected at baseline and subsequently every 6 months, coinciding with clinical frailty assessments. 3. Support: An Advanced Practice Nurse (APN) provides technical onboarding and follows up on non-compliance to ensure data completeness and address the digital divide. This intervention is purely observational and aimed at capturing the patient's subjectiv

Sponsors & Collaborators

  • Hospital del Mar

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2028-04-30
Completion
2028-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07607041 on ClinicalTrials.gov