Evolution of Physical Frailty and Patient-Reported Outcome Measures in Kidney Transplant Candidates: A Mixed-Methods Longitudinal Study Protocol
Starting soon
Conditions studied: Kidney Failure, Chronic, Frailty, Quality of Life, Kidney Transplantation, Patient Reported Outcome Measures
In brief
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.
Key facts
- Study ID
- NCT07607041
- Run by
- Hospital del Mar
- People needed
- 150
- Starts
- 2026-07-01
- Expected to finish
- 2028-07-01
- Last updated by the study team
- 2026-06-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- Ability to use or have regular access to a digital device (smartphone or tablet) for electronic Patient-Reported Outcome Measures (ePROMs) completion.
You may not qualify if…
- 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.
Full record on ClinicalTrials.gov
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