Clinical Research Directory
Browse clinical research sites, groups, and studies.
EVOLUTION IN FRAGILITY IN PEOPLE ON THE WAITING LIST FOR A KIDNEY TRANSPLANT
Sponsor: Hospital del Mar
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
150
Start Date
2026-04
Completion Date
2028-04
Last Updated
2026-05-26
Healthy Volunteers
No
Conditions
Interventions
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.
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