Kidney Failure, ChronicNCT07607041
Evolution of Physical Frailty and Patient-Reported Outcome Measures in Kidney Transplant Candidates: A Mixed-Methods Longitudinal Study Protocol
An observational study of Kidney Failure, Chronic and Frailty, run by Hospital del Mar.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic, Frailty, Quality of Life
- What is being tested?
- Longitudinal Frailty Assessment and Electronic Patient-Reported Outcome Measures (ePROMs)
- Type of treatment
- Pill or oral medicine
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Jul 2028
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Longitudinal Tracking of Physical Frailty and Health-Related Quality of Life Through Patient-Reported Outcome Measures in Adult Candidates on the Kidney Transplant Waiting List
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.
Read more
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.
Read the detailed description
Study Design and Framework This research employs a convergent-parallel mixed-methods design to evaluate frailty dynamics and patient-reported outcomes in Kidney Transplantation (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 Patient-Reported Outcomes Measurement Information System (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 (electronic PROMs [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 (Statistical Package for the Social Sciences, 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 PROMs 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.
- Conditions
- Kidney Failure, Chronic, Frailty, Quality of Life, Kidney Transplantation, Patient Reported Outcome Measures
- Being tested
- Longitudinal Frailty Assessment, Electronic Patient-Reported Outcome Measures (ePROMs)
- Keywords
- Kidney Transplantation, Waiting Lists, Health-Related Quality of Life, Digital Health, Longitudinal Studies, Mixed Methods Research, Hermeneutics, Patient-Centered Care, Technology Assessment, Biomedical
- Medical subject headings
- Kidney Failure, Chronic, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Longitudinal Frailty AssessmentOther
Also called Fried Frailty Phenotype Assessment, Physical Performance Monitoring, Comprehensive Frailty Evaluation, Clinical Frailty Scale (CFS)
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
Also called PROMIS-29 v2.0 Questionnaire, Digital Health Monitoring, Patient-Reported Quality of Life Assessment
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Longitudinal Frailty Assessment; Other: Electronic Patient-Reported Outcome Measures (ePROMs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 months, 12 months
Secondary outcomes (3)
Change in Patient-Reported Outcome Measures (PROMs)
Change over time in health-related quality of life measured using the Patient-Reported Outcomes Measurement Information System-29 version 2.0 (PROMIS-29 v2.0).
PROMIS-29 domain scores are reported as standardized T-scores ranging from approximately 20 to 80, where 50 represents the population mean and 10 the standard deviation.
Higher scores indicate more of the concept being measured:
Higher physical function and social participation scores indicate better functioning.
Higher anxiety, depression, fatigue, sleep disturbance, and pain interference scores indicate worse symptoms.
Each PROMIS domain score will be analyzed independently according to PROMIS scoring guidelines.
Measured: Baseline, 6 months, 12 months
Incidence of Clinical Transitions on the Waiting List
Incidence and time-to-event of major clinical transitions affecting transplant waiting list status, including kidney transplantation, temporary or permanent removal from the waiting list, and all-cause mortality.
Measured: 12 Months
Digital Tool Usability and Implementation Barriers
Assessment of the feasibility and usability of the electronic Patient-Reported Outcome Measures (ePROMs) platform during longitudinal follow-up.
Feasibility will be evaluated using questionnaire completion and adherence rates across the study period. Implementation barriers related to technology use and digital access will be identified and categorized through qualitative documentation obtained during Advanced Practice Nurse (APN) follow-up sessions.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Hospital del Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Bach Pascual, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607041
- Sponsor's protocol ID
- 2024/11603
- Status last verified
- Jun 2026
- First submitted
- 19 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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)
Publications
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.
PubMed 31078345Chu 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.
PubMed 31348438Cella 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.
PubMed 20685078Fried 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.
PubMed 11253156
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Tracking of Physical Frailty and Health-Related Quality of Life Through Patient-Reported Outcome Measures in Adult Candidates on the Kidney Transplant Waiting List
- ClinicalTrials.gov ID
- NCT07607041
- Acronym / sponsor ID
- 2024/11603
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hospital del MarUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Design and Framework This research employs a convergent-parallel mixed-methods design to evaluate frailty dynamics and patient-reported outcomes in Kidney Transplantation (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 Patient-Reported Outcomes Measurement Information System (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 (electronic PROMs [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 (Statistical Package for the Social Sciences, 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 PROMs 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney Transplant Candidates | – | Other: Longitudinal Frailty Assessment, Other: Electronic Patient-Reported Outcome Measures (ePROMs)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Longitudinal Frailty AssessmentAlso: Fried Frailty Phenotype Assessment, Physical Performance Monitoring, Comprehensive Frailty Evaluation, Clinical Frailty Scale (CFS)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. | Other | Kidney Transplant Candidates |
| Electronic Patient-Reported Outcome Measures (ePROMs)Also: PROMIS-29 v2.0 Questionnaire, Digital Health Monitoring, Patient-Reported Quality of Life AssessmentImplementation 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. | Other | Kidney Transplant Candidates |
Primary outcome
Change in Frailty Status (Fried Phenotype)
Time frame: Baseline, 6 months, 12 months
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.
3 secondary outcomes
Change in Patient-Reported Outcome Measures (PROMs)
Time frame: Baseline, 6 months, 12 months
Incidence of Clinical Transitions on the Waiting List
Time frame: 12 Months
Digital Tool Usability and Implementation Barriers
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Background: PubMed 31078345Bardes 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.
- Background: PubMed 31348438Chu 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.
- Background: PubMed 20685078Cella 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.
- Background: PubMed 11253156Fried 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.
- Department of Nephrology, Hospital del Mar (Barcelona). Primary clinical site for participant recruitment and follow-up.Link provided by the sponsor.
- Official PROMIS HealthMeasures website. Provides detailed information on the validity and scoring of the PROMIS-29 v2.0 questionnaire used in this study.Link provided by the sponsor.
- Spanish National Transplant Organization (ONT). Provides the regulatory framework and national standards for kidney transplant waiting list management.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Failure, Chronic and Frailty, run by Hospital del Mar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Bach Pascual, RN, MSN i PhDc (+34 648653656, abach@hmar.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Frailty Status (Fried Phenotype) (time frame: Baseline, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07607041, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.