- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07529470
Rockwood Frailty Index and Survival in Hospital-at-Home Patients (DOMMOR)
Assessment of One-year Mortality Risk Using the Modified 34-item Rockwood Index
Study Overview
Status
Detailed Description
This retrospective longitudinal observational cohort study included patients aged 65 years or older admitted to a Hospital-at-Home (HaH) unit between January 1, 2021 and December 31, 2024. All patients 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.
The primary outcome was overall survival, defined as time from discharge from the HaH unit to death from any cause. Survival analyses were conducted using Kaplan-Meier curves and multivariate Cox proportional hazards regression models adjusted for relevant demographic, clinical, and laboratory covariates.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Valencia
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Valencia, Valencia, Spain, 46026
- Hospital Universitari i Politecnic La Fe
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Incomplete data for frailty index calculation
- Immediate loss to follow-up after discharge
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Survival
Time Frame: 1 year
|
Time from discharge from the Hospital-at-Home unit to death from any cause.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparative prognostic performance of the Rockwood Frailty Index versus Charlson Comorbidity Index
Time Frame: 1 year
|
Comparison of the prognostic performance of the Rockwood Frailty Index and the Charlson Comorbidity Index for predicting overall survival. Measure: Hazard Ratios (HRs) for overall survival for each index. Unit of Measure: Hazard ratio Measurement Tool / Method: Rockwood Frailty Index; Charlson Comorbidity Index; Cox proportional hazards regression models. |
1 year
|
|
Association between age and overall survival
Time Frame: 1 year
|
Overall survival according to age at baseline. Measure: Hazard Ratio (HR) for overall survival per year increase in age Unit of Measure: Hazard ratio Measurement Tool / Method: Cox proportional hazards regression model |
1 year
|
|
Association between sex and overall survival
Time Frame: 1 year
|
Description: Overall survival according to sex at baseline. Measure: Hazard Ratio (HR) for overall survival comparing sex categories. Unit of Measure: Hazard ratio Measurement Tool / Method: Cox proportional hazards regression model |
1 year
|
|
Association between overall survival and clinical variables (Charlson Comorbidity Index)
Time Frame: 1 year
|
Overall survival according to Charlson Comorbidity Index at baseline. Measure: Hazard Ratio (HR) for overall survival per point increase in Charlson Comorbidity Index. Unit of Measure: Hazard ratio Measurement Tool / Method: Charlson Comorbidity Index; Cox proportional hazards regression model |
1 year
|
|
Association between overall survival and clinical variables (Barthel Index)
Time Frame: 1 year
|
Description: Overall survival according to the Barthel Index at baseline. Measure: Hazard Ratio (HR) for overall survival per point increase in Barthel Index. Unit of Measure: Hazard ratio Measurement Tool / Method: Barthel Index; Cox proportional hazards regression model |
1 year
|
|
Association between overall survival and laboratory parameters (C-reactive protein)
Time Frame: 1 year
|
Overall survival according to C-reactive protein levels at baseline. Measure: Hazard Ratio (HR) for overall survival per unit increase in C-reactive protein. Unit of Measure: Hazard ratio Measurement Tool / Method: Serum C-reactive protein concentration (mg/L); Cox proportional hazards regression model |
1 year
|
|
Association between overall survival and laboratory parameters (albumin)
Time Frame: 1 year
|
Description: Overall survival according to serum albumin levels at baseline. Measure: Hazard Ratio (HR) for overall survival per unit increase in serum albumin. Unit of Measure: Hazard ratio Measurement Tool / Method: Serum albumin concentration (g/dL); Cox proportional hazards regression model |
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: 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)
- Study Chair: 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)
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-0459-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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