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

NCT07607041 | Not Yet Recruiting

• 1 other identifier: 2024/11603
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Kidney Transplantation; Waiting Lists; Health-Related Quality of Life; Digital Health; Longitudinal Studies; Mixed Methods Research; Hermeneutics; Patient-Centered Care; Technology Assessment, Biomedical

Outcome Measures

Primary Outcomes (1)

• Change in Frailty Status (Fried Phenotype)

  Change in frailty status over time assessed using the Fried Frailty Phenotype cumulative score, with a total score ranging from 0 to 5 points, where higher scores indicate greater physical frailty. Frailty status categories are defined as: Non-frail: 0 points Pre-frail: 1-2 points Frail: 3-5 points The outcome measure will assess longitudinal changes in the cumulative frailty score and frailty category during the patient's time on the kidney transplant waiting list.

  Baseline, 6 months, 12 months

Secondary Outcomes (3)

• Change in Patient-Reported Outcome Measures (PROMs)

  Baseline, 6 months, 12 months

• Incidence of Clinical Transitions on the Waiting List

  12 Months

• Digital Tool Usability and Implementation Barriers

  12 months

Study Arms (1)

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.

Other: Longitudinal Frailty Assessment; Other: Electronic Patient-Reported Outcome Measures (ePROMs)

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.

Also known as: Fried Frailty Phenotype Assessment, Physical Performance Monitoring, Comprehensive Frailty Evaluation, Clinical Frailty Scale (CFS)

Kidney Transplant Candidates

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.

Also known as: PROMIS-29 v2.0 Questionnaire, Digital Health Monitoring, Patient-Reported Quality of Life Assessment

Kidney Transplant Candidates

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients with End-Stage Renal Disease (ESRD), also classified as Stage 5 chronic kidney disease, managed at the Nephrology Department of Hospital del Mar (Barcelona). This clinical cohort includes patients currently receiving renal replacement therapy (either maintenance haemodialysis or peritoneal dialysis) as well as individuals in the pre-dialysis stage who have been formally referred for comprehensive kidney transplant evaluation. The target population is characterized by a high burden of medical comorbidity and varying degrees of physical frailty associated with chronic uraemia and long-term dialysis treatment.

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.

Sponsors & Collaborators

• Hospital del Mar: lead

Related Publications (4)

• Bardes JM, Benjamin E, Schellenberg M, Inaba K, Demetriades D. Old Age With a Traumatic Mechanism of Injury Should Be a Trauma Team Activation Criterion. J Emerg Med. 2019 Aug;57(2):151-155. doi: 10.1016/j.jemermed.2019.04.003. Epub 2019 May 9.

  PMID: 31078345 BACKGROUND

• Chu NM, Deng A, Ying H, Haugen CE, Garonzik Wang JM, Segev DL, McAdams-DeMarco MA. Dynamic Frailty Before Kidney Transplantation: Time of Measurement Matters. Transplantation. 2019 Aug;103(8):1700-1704. doi: 10.1097/TP.0000000000002563.

  PMID: 31348438 BACKGROUND

• Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.

  PMID: 20685078 BACKGROUND

• Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

  PMID: 11253156 BACKGROUND

Related Links

• Department of Nephrology, Hospital del Mar (Barcelona). Primary clinical site for participant recruitment and follow-up.
• Official PROMIS HealthMeasures website. Provides detailed information on the validity and scoring of the PROMIS-29 v2.0 questionnaire used in this study.
• Spanish National Transplant Organization (ONT). Provides the regulatory framework and national standards for kidney transplant waiting list management.

MeSH Terms

Conditions

Kidney Failure, Chronic; Frailty

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Anna Bach Pascual, RN, MSN i PhDc

CONTACT

+34 648653656; abach@hmar.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 26, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share