Home Care Services, Hospital-BasedDOMMORNCT07529470
Rockwood Frailty Index and Survival in Hospital-at-Home Patients
An observational study of Home Care Services, Hospital-Based and Frailty, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Home Care Services, Hospital-Based, Frailty, Mortality
- What is being tested?
- 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
- How many people
- 2,610 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- Incomplete data for frailty index calculation
- Immediate loss to follow-up after discharge
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- 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
- Keywords
- Hospital at home, Frailty, Survival, Complex Chronic Patients, Rockwood Index
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 compOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Time from discharge from the Hospital-at-Home unit to death from any cause.
Measured: 1 year
Secondary outcomes (7)
Comparative prognostic performance of the Rockwood Frailty Index versus Charlson Comorbidity Index
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.
Measured: 1 year
Association between age and overall survival
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
Measured: 1 year
Association between sex and overall survival
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
Measured: 1 year
Association between overall survival and clinical variables (Charlson Comorbidity Index)
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
Measured: 1 year
Association between overall survival and clinical variables (Barthel Index)
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
Measured: 1 year
Association between overall survival and laboratory parameters (C-reactive protein)
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
Measured: 1 year
Association between overall survival and laboratory parameters (albumin)
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 Jan 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Home Care Services, Hospital-BasedStudies 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
- Retrospective
- Enrolment
- 2,610 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigacion Sanitaria La Fe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vicente Ruiz García, Hospital Universitario La Fe
- Investigators
- Vicente Ruiz Garcia, MD, PhD, Principal investigator, Hospital at Home Unit - Hospital UiP La Fe Valencia Avda Fernando Abril Martorell 106 Torre B Planta 1 Valencia 26206 (SPAIN)Elisa Soriano Melchor, MD, PhD, Study chair, Hospital at Home Unit - Hospital UiP La Fe Valencia Avda Fernando Abril Martorell 106 Torre B Planta 1 Valencia 26206 (SPAIN)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529470
- Sponsor's protocol ID
- 2024-0459-1
- Acronym
- DOMMOR
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 34519246Kojima 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.
PubMed 29040347Ko 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.
PubMed 41223731Salminen 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.
PubMed 31654244Amblas-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.
PubMed 28029467Martinez-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.
PubMed 28757333Rockwood 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.
PubMed 16129869
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of One-year Mortality Risk Using the Modified 34-item Rockwood Index
- ClinicalTrials.gov ID
- NCT07529470
- Acronym / sponsor ID
- DOMMOR / 2024-0459-1
- Keywords
- Hospital at home, Frailty, Survival, Complex Chronic Patients, Rockwood Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,610 participants (actual)
- Lead sponsor
- Instituto de Investigacion Sanitaria La FeUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 14 Apr 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older adults with complex chronic diseases or palliative care needs | – | 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 compAll 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Incomplete data for frailty index calculation
- Immediate loss to follow-up after discharge
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 |
|---|---|---|
| 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 compPatients 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. | Other | Older adults with complex chronic diseases or palliative care needs |
Primary outcome
Overall Survival
Time frame: 1 year
Time from discharge from the Hospital-at-Home unit to death from any cause.
7 secondary outcomes
Comparative prognostic performance of the Rockwood Frailty Index versus Charlson Comorbidity Index
Time frame: 1 year
Association between age and overall survival
Time frame: 1 year
Association between sex and overall survival
Time frame: 1 year
Association between overall survival and clinical variables (Charlson Comorbidity Index)
Time frame: 1 year
Association between overall survival and clinical variables (Barthel Index)
Time frame: 1 year
Association between overall survival and laboratory parameters (C-reactive protein)
Time frame: 1 year
Association between overall survival and laboratory parameters (albumin)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Background: PubMed 34519246Hall 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.
- Background: PubMed 29040347Kojima 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.
- Background: PubMed 41223731Ko 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.
- Background: PubMed 31654244Salminen 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.
- Background: PubMed 28029467Amblas-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.
- Background: PubMed 28757333Martinez-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.
- Background: PubMed 16129869Rockwood 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.
- Individual participant dataSharing planned: Yes. 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.
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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. This study is not recruiting at the moment.
Vicente Ruiz Garcia, MD, PhD principal investigator
Hospital at Home Unit - Hospital UiP La Fe Valencia Avda Fernando Abril Martorell 106 Torre B Planta 1 Valencia 26206 (SPAIN)
Elisa Soriano Melchor, MD, PhD study chair
Hospital at Home Unit - Hospital UiP La Fe Valencia Avda Fernando Abril Martorell 106 Torre B Planta 1 Valencia 26206 (SPAIN)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Home Care Services, Hospital-Based and Frailty, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 1 year). 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 NCT07529470, which also lists 7 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 21 Apr 2026.