EVOLUTION IN FRAGILITY IN PEOPLE ON THE WAITING LIST FOR A KIDNEY TRANSPLANT
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Study Design and Framework This research employs a convergent-parallel mixed-methods design to evaluate frailty dynamics and patient-reported outcomes in kidney transplant (KT) candidates. The quantitative component is a longitudinal observational study, while the qualitative component is grounded in Heideggerian hermeneutic phenomenology to explore the lived experience of patients during the waiting list period.
Quantitative Procedures and Data Collection Participants will be recruited during their initial KT evaluation at Hospital del Mar (Barcelona). Frailty will be assessed using the Fried Phenotype (assessing weight loss, exhaustion, physical activity, walk time, and grip strength) at baseline and subsequently every six months while the patient remains on the waiting list.
To monitor Patient-Reported Outcome Measures (PROMs), the study utilizes the PROMIS-29 v2.0 questionnaire. This instrument covers seven health domains: physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles/activities, and pain interference. Data collection will be performed via a digital platform (ePROMs), allowing for real-time monitoring. For patients facing technological or language barriers, an Advanced Practice Nurse (APN) will provide support to ensure data completeness and minimize selection bias.
Qualitative Exploration A purposive sample of participants will undergo in-depth semi-structured interviews. These sessions will focus on the subjective meaning of frailty, the impact of the waiting period on daily life, and the experience of using digital health tools. Interviews will be audio-recorded, transcribed verbatim, and analyzed using thematic analysis to identify core existential themes.
Quality Assurance and Data Management
- Data Validation: A data dictionary has been developed, defining each variable, its source, and acceptable ranges to ensure consistency.
- Source Data Verification: Data entered into the electronic Case Report Form (eCRF) will be cross-referenced with electronic medical records to ensure accuracy.
- Standard Operating Procedures (SOPs): Specific SOPs are in place for patient recruitment, the standardized administration of physical performance tests (e.g., handgrip strength using a dynamometer), and the management of technical issues with the ePROM platform.
Statistical Analysis Plan (SAP) Quantitative data will be analyzed using SPSS v.25. Descriptive statistics will summarize baseline characteristics. Longitudinal changes in frailty scores and PROMs will be analyzed using linear mixed models or generalized estimating equations (GEE) to account for repeated measures. The relationship between frailty status and health-related quality of life (HRQoL) will be assessed using correlation coefficients and multivariate regression models adjusted for age, comorbidity, and time on dialysis.
Missing Data Plan The study aims to minimize missing data through APN-led follow-up. If data are missing at random, multiple imputation techniques will be considered. For patients unable to use digital tools, paper-based alternatives or assisted entry will be provided to reduce non-response bias.
Sample Size Assessment The sample size is based on the prevailing activity of the kidney transplant unit, aiming to include all eligible candidates over the recruitment period (estimated N ≈ 150-200) to ensure sufficient power for detecting longitudinal changes in frailty prevalence and its association with PROMs.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Anna Bach Pascual, RN, MSN i PhDc
- Numero di telefono: +34 648653656
- Email: abach@hmar.cat
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Patients aged 18 years or older.
- Diagnosed with Chronic Kidney Disease (CKD) Stage 5.
- Currently undergoing clinical evaluation for kidney transplantation on the deceased-donor kidney transplant waiting list at Hospital del Mar.
- Ability to understand and provide written informed consent.
- Ability to use or have access to a digital device (smartphone/tablet) for ePROM completion.
Exclusion Criteria:
- Severe cognitive impairment or psychiatric disorders that prevent the reliable completion of questionnaires or physical tests.
- Major physical disability that precludes the assessment of gait speed or handgrip strength (e.g., bilateral leg amputation or severe hand deformity).
- Acute medical condition requiring hospitalization at the time of enrollment (assessment can be deferred).
- Language barrier that prevents understanding the study or the qualitative interview.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
Kidney Transplant Candidates
This is a single-group observational cohort of adult patients with Stage 5 Chronic Kidney Disease (CKD) who are undergoing evaluation for or are already active on the deceased-donor kidney transplant waiting list. The nature of this group is characterized by the transition from advanced chronic illness to potential transplantation. All participants will undergo a longitudinal follow-up (every 6 months) to monitor frailty status and health-related quality of life. The study focuses on the "frailty dynamics" during the waiting period. Data collection includes: Physical assessments (Fried Phenotype: handgrip strength, gait speed). Patient-Reported Outcome Measures (PROMs) via the PROMIS-29 digital platform (ePROMs). Qualitative hermeneutic interviews for a selected subset to explore the lived experience of frailty. No clinical intervention or medication will be administered as part of this study protocol. |
Intervention Description (Intervention 1: Frailty Assessment) Systematic multidimensional assessment of frailty conducted by an Advanced Practice Nurse (APN) specialized in nephrology. Components of assessment:
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.
Altri nomi:
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:
This intervention is purely observational and aimed at capturing the patient's subjectiv
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Frailty Status (Fried Phenotype)
Lasso di tempo: Baseline, 6 months, 12 months
|
Frailty is assessed using the Fried Phenotype, which includes five criteria: unintended weight loss, self-reported exhaustion, low physical activity, slow gait speed (4-meter walk test), and weak grip strength (measured by a hydraulic dynamometer).Scoring: Each criterion is scored 0 (absent) or 1 (present). Non-frail: 0 points Pre-frail: 1-2 points Frail: 3-5 points The primary outcome is the longitudinal change or transition between these categories during the waiting list period. |
Baseline, 6 months, 12 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Health-Related Quality of Life (HRQoL)
Lasso di tempo: Baseline, 6 months, 12 months
|
Assessed using the PROMIS-29 v2.0 questionnaire. This tool measures 7 domains: Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, and Pain Interference. Scoring: Each domain is scored on a T-score metric, where 50 is the mean of the relevant reference population (SD = 10). Higher scores represent more of the concept being measured (e.g., higher anxiety, better physical function). |
Baseline, 6 months, 12 months
|
|
Clinical Transitions on the Waiting List
Lasso di tempo: 12 Months
|
Incidence of major clinical events that alter the patient's status. Events monitored: Successful kidney transplantation, removal from the waiting list due to clinical worsening, or death while on the list. |
12 Months
|
|
Digital Tool Usability and Barriers
Lasso di tempo: 12 months
|
Evaluation of the feasibility and barriers to using the ePROM platform.
Assessment: Measured through the completion rate of the digital questionnaires and the qualitative feedback regarding technological challenges or the "digital divide" as identified during APN follow-up.
|
12 months
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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.
- 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.
- 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.
Collegamenti utili
- 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.
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Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Processi patologici
- Malattie urogenitali maschili
- Malattie renali
- Malattie urologiche
- Malattie urogenitali femminili
- Malattie urogenitali femminili e complicanze della gravidanza
- Malattia cronica
- Attributi della malattia
- Insufficienza renale
- Insufficienza renale cronica
- Condizioni patologiche, segni e sintomi
- Fragilità
- Insufficienza renale cronica
Altri numeri di identificazione dello studio
- 2024/11603
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Individual participant data (IPD) will not be shared at this time to protect the confidentiality of the participants and the integrity of the ongoing doctoral thesis. The data collected involves sensitive clinical information and qualitative interviews within a specific, small-scale clinical setting (kidney transplant waiting list).
However, the study results will be disseminated through peer-reviewed publications and conference presentations. Requests for access to aggregate data or specific methodological details can be directed to the Principal Investigator and will be considered on a case-by-case basis, subject to approval by the Institutional Review Board (CEIm) and in compliance with the General Data Protection Regulation (GDPR)
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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