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

Sponsor
Hospital del Mar
Study ID
NCT07607041
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Longitudinal Frailty Assessment — OTHER
    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.
  • Electronic Patient-Reported Outcome Measures (ePROMs) — OTHER
    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.

Study Details

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 Dates

First listed
May 26, 2026
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: Kidney Transplant Candidates
    This is a single-group observational cohort of adult patients with Stage 5 Chronic Kidney Disease (CKD) undergoing evaluation or active on the deceased-donor kidney transplant waiting list. All participants undergo a longitudinal follow-up every six months to monitor frailty dynamics and health perceptions. Data collection includes: * Physical assessments: Evaluation using the Fried Phenotype framework (measuring handgrip strength and gait speed). * Patient-Reported Outcome Measures (PROMs): Assessment via the digital platform for the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 (electronic PROMs \[ePROMs\]). * Qualitative exploration: Hermeneutic interviews for a selected subset to explore the lived experience of frailty. No clinical intervention or medication will be administered.

Primary Outcome Measure

Change in Frailty Status (Fried Phenotype) [ Time Frame: Baseline, 6 months, 12 months ]

Central Contacts

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