NCT07529470

Brief Summary

Frailty is a key determinant of prognosis in older adults with complex chronic conditions and in palliative care settings. The Rockwood Frailty Index (RFI), based on the accumulation of health deficits, has demonstrated prognostic value across multiple clinical contexts. This study evaluates the association between the RFI and overall survival in complex chronic and palliative patients (oncologic and non-oncologic) treated in a Hospital-at-Home (HaH) unit.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,610

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

4 years

First QC Date

April 8, 2026

Last Update Submit

April 16, 2026

Conditions

Keywords

Hospital at homeFrailtySurvivalComplex Chronic PatientsRockwood Index

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    Time from discharge from the Hospital-at-Home unit to death from any cause.

    1 year

Secondary Outcomes (7)

  • Comparative prognostic performance of the Rockwood Frailty Index versus Charlson Comorbidity Index

    1 year

  • Association between age and overall survival

    1 year

  • Association between sex and overall survival

    1 year

  • Association between overall survival and clinical variables (Charlson Comorbidity Index)

    1 year

  • Association between overall survival and clinical variables (Barthel Index)

    1 year

  • +2 more secondary outcomes

Study Arms (1)

Older adults with complex chronic diseases or palliative care needs

All patients must had a recorded modified Rockwood Frailty Index (RFI) at admission and were subsequently followed through a structured case-management program led by nurse case managers via scheduled telephone follow-up. Patients were classified into three clinical groups: complex chronic patients, non-oncologic palliative patients, and oncologic palliative patients. Non-oncologic palliative status was defined by an RFI ≥0.53, while complex chronic patients had an RFI \>0.37 and \<0.53. Oncologic palliative patients were classified based on referral from Oncology services regardless of frailty level.

Other: Patients identified and followed in this cohort received scheduled supportive telephone calls every two weeks if classified in the oncologic palliative care group, and once monthly in the case of comp

Interventions

Patients in this cohort received scheduled supportive telephone calls every two weeks if classified under palliative care (oncologic or chronic conditions), and once monthly if classified as chronic non-palliative patients.

Older adults with complex chronic diseases or palliative care needs

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged over 65 years with a high comorbidity burden and functional dependence, and/or with advanced cancer requiring symptom management and end-of-life care.

You may qualify if:

  • Age ≥65 years
  • Admission to the Hospital-at-Home unit during the study period
  • Recorded modified Rockwood Frailty Index at admission
  • Participation in the post-discharge case management follow-up program

You may not qualify if:

  • Incomplete data for frailty index calculation
  • Immediate loss to follow-up after discharge

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari i Politècnic La Fe

Valencia, Valencia, 46026, Spain

Location

Related Publications (7)

  • Hall A, Boulton E, Kunonga P, Spiers G, Beyer F, Bower P, Craig D, Todd C, Hanratty B. Identifying older adults with frailty approaching end-of-life: A systematic review. Palliat Med. 2021 Dec;35(10):1832-1843. doi: 10.1177/02692163211045917. Epub 2021 Sep 14.

    PMID: 34519246BACKGROUND
  • Kojima G, Iliffe S, Walters K. Frailty index as a predictor of mortality: a systematic review and meta-analysis. Age Ageing. 2018 Mar 1;47(2):193-200. doi: 10.1093/ageing/afx162.

    PMID: 29040347BACKGROUND
  • Ko W, Jeong H, Yim HW. Frailty Index Predicts Future All-cause Mortality and Quality of Life: A 2-Year Follow-up Study Among Korean Older Adults From a Population-based Cohort Study. J Prev Med Public Health. 2025 Nov;58(6):572-580. doi: 10.3961/jpmph.25.210. Epub 2025 Nov 10.

    PMID: 41223731BACKGROUND
  • Salminen M, Viljanen A, Eloranta S, Viikari P, Wuorela M, Vahlberg T, Isoaho R, Kivela SL, Korhonen P, Irjala K, Lopponen M, Viikari L. Frailty and mortality: an 18-year follow-up study among Finnish community-dwelling older people. Aging Clin Exp Res. 2020 Oct;32(10):2013-2019. doi: 10.1007/s40520-019-01383-4. Epub 2019 Oct 25.

    PMID: 31654244BACKGROUND
  • Amblas-Novellas J, Martori JC, Molist Brunet N, Oller R, Gomez-Batiste X, Espaulella Panicot J. [Frail-VIG index: Design and evaluation of a new frailty index based on the Comprehensive Geriatric Assessment]. Rev Esp Geriatr Gerontol. 2017 May-Jun;52(3):119-127. doi: 10.1016/j.regg.2016.09.003. Epub 2016 Oct 28. Spanish.

    PMID: 28029467BACKGROUND
  • Martinez-Velilla N, Herce PA, Herrero AC, Gutierrez-Valencia M, Saez de Asteasu ML, Mateos AS, Zubillaga AC, Beroiz BI, Jimenez AG, Izquierdo M. Heterogeneity of Different Tools for Detecting the Prevalence of Frailty in Nursing Homes: Feasibility and Meaning of Different Approaches. J Am Med Dir Assoc. 2017 Oct 1;18(10):898.e1-898.e8. doi: 10.1016/j.jamda.2017.06.016. Epub 2017 Jul 27.

    PMID: 28757333BACKGROUND
  • Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.

    PMID: 16129869BACKGROUND

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Vicente Ruiz Garcia, MD, PhD

    Hospital at Home Unit - Hospital UiP La Fe Valencia Avda Fernando Abril Martorell 106 Torre B Planta 1 Valencia 26206 (SPAIN)

    PRINCIPAL INVESTIGATOR
  • Elisa Soriano Melchor, MD, PhD

    Hospital at Home Unit - Hospital UiP La Fe Valencia Avda Fernando Abril Martorell 106 Torre B Planta 1 Valencia 26206 (SPAIN)

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 8, 2026

First Posted

April 14, 2026

Study Start

January 1, 2021

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) underlying the results reported in publications will be shared. The shared IPD will include baseline demographic and clinical characteristics, outcome measures, and relevant covariates. Data will be made available upon reasonable request after publication of the study results, subject to institutional approval and in accordance with applicable data protection and privacy regulations.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Starting after publication of the study results; duration of availability will be determined according to institutional policies.
Access Criteria
Qualified researchers who submit a reasonable research proposal will be able to access the de-identified individual participant data (IPD) and supporting documentation (such as the data dictionary). Access will be granted after review and approval by the study investigators and the corresponding institution. Data will be provided in a de-identified format and shared through secure data transfer methods. Researchers may be required to sign a data use agreement to ensure compliance with ethical standards, data protection regulations, and intended use of the data.
More information

Locations