[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643721":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":10,"centralContacts":33,"locations":10,"responsibleParty":39,"collaborators":10,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":10,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":10,"enrollmentInfo":52,"targetDuration":55,"studyType":56,"phases":10,"briefSummary":57,"conditions":58,"keywords":64,"overallStatus":73,"whyStopped":10,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":10},{"fullName":5,"class":6},"Hospital del Mar","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Kidney Transplant Candidates",null,"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.\n\nData collection includes:\n\n* Physical assessments: Evaluation using the Fried Phenotype framework (measuring handgrip strength and gait speed).\n* Patient-Reported Outcome Measures (PROMs): Assessment via the digital platform for the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 (electronic PROMs \\[ePROMs\\]).\n* Qualitative exploration: Hermeneutic interviews for a selected subset to explore the lived experience of frailty.\n\nNo clinical intervention or medication will be administered.",[13,14],"Other: Longitudinal Frailty Assessment","Other: Electronic Patient-Reported Outcome Measures (ePROMs)",[16,25],{"type":6,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"Longitudinal Frailty Assessment","Systematic multidimensional assessment of physical frailty conducted by an Advanced Practice Nurse (APN) specialized in nephrology.\n\nThe evaluation encompasses the following components:\n\n* 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).\n* Clinical Frailty Scale (CFS): Global clinical judgment score based on the patient's overall fitness and functional independence.\n* Short Physical Performance Battery (SPPB): Standardized test battery to objectively assess balance, gait speed, and lower limb strength through timed chair stands.\n\nFrequency: Assessments will be performed at baseline and every 6 months (+\u002F- 1 month) throughout the patient's presence on the kidney transplant waiting list. Standardized protocols ensure data reproducibility.",[9],[21,22,23,24],"Fried Frailty Phenotype Assessment","Physical Performance Monitoring","Comprehensive Frailty Evaluation","Clinical Frailty Scale (CFS)",{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"Electronic Patient-Reported Outcome Measures (ePROMs)","Implementation of a digital health strategy to monitor patient-reported outcomes throughout the kidney transplant waiting list period.\n\nCore 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\u002Factivities, pain interference, and pain intensity.\n\nProcedure: • 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.\n\nThis observational strategy aims to capture the patient's subjective health status.",[9],[30,31,32],"PROMIS-29 v2.0 Questionnaire","Digital Health Monitoring","Patient-Reported Quality of Life Assessment",[34],{"name":35,"role":36,"phone":37,"phoneExt":10,"email":38},"Anna Bach Pascual, RN, MSN i PhDc","CONTACT","+34 648653656","abach@hmar.cat",{"type":40,"investigatorFullName":41,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Anna Bach Pascual","Nurse","100643721","evolution-of-physical-frailty-and-patient-reported-outcome-measures-in-kidney-transplant-candidates-a-mixed-methods-longitudinal-study-protocol-100643721",false,"NCT07607041","Evolution of Physical Frailty and Patient-Reported Outcome Measures in Kidney Transplant Candidates: A Mixed-Methods Longitudinal Study Protocol","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","Inclusion Criteria:\n\n* Patients aged 18 years or older.\n* Diagnosed with Stage 5 chronic kidney disease (CKD).\n* Currently undergoing clinical evaluation for or actively listed on the deceased-donor kidney transplant waiting list at Hospital del Mar (Barcelona).\n* Cognitive and physical ability to understand and provide written informed consent.\n* Ability to use or have regular access to a digital device (smartphone or tablet) for electronic Patient-Reported Outcome Measures (ePROMs) completion.\n\nExclusion Criteria:\n\n* Severe cognitive impairment or active psychiatric disorders that prevent the reliable completion of questionnaires or physical tests.\n* 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).\n* Acute medical illness requiring hospitalization at the time of enrolment.\n* Total language barrier that prevents understanding the study components or the qualitative interview.","ALL","18 Years",{"count":53,"type":54},150,"ESTIMATED","24 Months","OBSERVATIONAL","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.\n\nThe 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.\n\nThe 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.\n\nIn short, this work aims to help patients reach the day of their surgery in the best possible condition.",[59,60,61,62,63],"Kidney Failure, Chronic","Frailty","Quality of Life","Kidney Transplantation","Patient Reported Outcome Measures",[62,65,66,67,68,69,70,71,72],"Waiting Lists","Health-Related Quality of Life","Digital Health","Longitudinal Studies","Mixed Methods Research","Hermeneutics","Patient-Centered Care","Technology Assessment, Biomedical","NOT_YET_RECRUITING","2026-06-05",{"date":76,"type":77},"2026-06-08","ACTUAL",{"date":79,"type":54},"2026-07",{"date":81,"type":54},"2028-07",{"name":5,"class":6}]