Rockwood Frailty Index and Survival in Hospital-at-Home Patients (DOMMOR)

April 16, 2026 updated by: Vicente Ruiz García, Instituto de Investigacion Sanitaria La Fe

Assessment of One-year Mortality Risk Using the Modified 34-item Rockwood Index

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.

Study Overview

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

Observational

Enrollment (Actual)

2610

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Valencia
      • Valencia, Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

April 8, 2026

First Submitted That Met QC Criteria

April 8, 2026

First Posted (Actual)

April 14, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Starting after publication of the study results; duration of availability will be determined according to institutional policies.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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