SyndromeFRAILTOOLSNCT02637518
Comprehensive Validation of Frailty Assessment Tools in Older Adults in Different Clinical and Social Settings
An observational study of Syndrome, run by Hospital Universitario Getafe at 1 site in Spain.
Trial summary
There is a proved strong evidence of the usefulness of frailty as a predictive factor of relevant and desired outcomes in populations of older adults. Several studies have been published showing the utility of the concept in improving the prognosis accuracy and the prediction of different risks (hospitalisations… Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Syndrome
- What is being tested?
- Assessment of frailty tools in elderly people
- How many people
- 1,940 participants
- Where
- 1 siteSpain
- Study dates
- May 2015to May 2018
- 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 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: People older than 75 years old will be included, recruited from different clinical settings such as clinical (hospital or primary care) and social (nursing homes).
Who may be able to join
- People older than 75 years old, who sign the informed consent after accepting their participation.
Who cannot join
- General exclusion criteria will be an MMSE score less than 20 points or having a terminal illness (life expectancy < 6 months).
- Subjects included from the hospital ward (Acute Geriatric Unit and Outpatient
- Geriatric Consultation) and primary care will have additional exclusion criteria: dependency in more than 2 Instrumental Activities of Daily Living (IADL) in women (Lawton < 6), and in more than 3 IADL in men (Lawton < 5).
- Subjects seen in a nursing home setting will be excluded if they obtain less than 40 points in the Barthel index.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de Getafe
Getafe, Madrid, 28905
LEOCADIO RODRIGUEZ MAÑAS, MD, PhD, +34916839360 ext. 2760, leocadio.rodriguez@salud.madrid.org
MARTA CHECA LOPEZ, MD, +34916839360 ext. 2760, marta.checa@salud.madrid.org
About this study
Official title: A Comprehensive Validation of Frailty Assessment Tools to Screen and Diagnose Frailty in Different Clinical and Social Settings and to Provide Instruments for Integrated Care in Older Adults.
There is a proved strong evidence of the usefulness of frailty as a predictive factor of relevant and desired outcomes in populations of older adults. Several studies have been published showing the utility of the concept in improving the prognosis accuracy and the prediction of different risks (hospitalisations, surgical and non surgical complications, length of stay, death, incident disability, etc.) in emergency departments, surgical patients, and inpatients with cardiovascular disease. The studies have placed the focus in assessing population risk, while the validation process for these instruments as diagnosis or screening tools has been usually neglected. FRAILTOOLS aims to assess the usefulness as screening and diagnosis tools of some selected instruments to detect frailty in both clinical (Hospital and Primary Care) and social (Nursing Homes) settings, providing diagnostic algorithms clinically sound. Target groups are all of those older adults at risk of frailty (pre-frail) plus those that are frail and are at risk for developing disability. According to the published prevalence of these two conditions, the target population concerned by this project represents around 40-50% of people older than 65, and 60-70% of people older than 75. Once determining the best tools of screening and diagnosis in different settings of care, investigators will research conclusions of these people wherever the level of care they need and currently use. The benefit will spend to the Health System and Social Care as it will provide validated instruments that are necessary to provide an appropriate care for older adults by means of a comprehensive, continued, coordinated and integrated care.
Read the detailed description
Quality assurance plan:
According to the European's Commission guidelines, the procedure for quality control focuses on the deliverables revision and in the quality of each procedure. The deliverables will be sent to the Administrative committee. The administrative Committee, composed by the Project's Promoter and its associates, will assume the role as a quality manager. It includes the following tasks:
Making sure of the monitoring of all of the changes in documentation. Making sure the activity's coordination and reports are completed according to an adequate quality and in an appropriate manner.
Reviewing the contract deliverables. Monitoring and auditing the project's activities according to plan, making the specific revisions of the contractual deliverables, directed to the achievement of the established objectives.
The electronic Case Report Form (eCRF) has been designed to capture all data required in the protocol. A unique eCRF will be completed for subject, taking into account the protection law in each country of the study.Subjects will be identified by a unique subject number (with key held by the relevant partner), so none identification card number will be recorded on the eCRF or the database. The monitor will guarantee that the eCRF is fully and correctly fill up according to the source documents. The researcher will assure that all data recorded in the eCRF coincide with the information recorded in the source documents.
Plan for missing data to address situations where variables are reported as missing:
The investigators will check the missing data in each eCRF and source documents.
Statistical analysis:
Investigator will assess the associations of each scale with the outcome for each setting and outcome through logistic regressions. First, investigators will compute the classification performance (sensitivity, specificity, Receptors Operational Curve (ROC), Area Under the Curve (AUC), predictive values, likelihood ratios) for each model. Second, investigators will study the feasibility of the models taking into account the time needed for the scale and the percentage of patients that can be assessed per case. Investigators will evaluate the sensitivity to change of the scales and the covariance of the scales with other measures as the SPPB through a mixed linear model.
Sample Size: Participants will be recruited in Spain, Italy, France, United Kingdom and Poland. The total sample will be of 1.940 subjects. Each participating centre will have to recruit a total of 388 patients, corresponding to 97 subjects in each clinical setting by centre.
- Conditions
- Syndrome
- Being tested
- Assessment of frailty tools in elderly people
- Keywords
- Frailty, Frailty screening tools, Clinical settings, Social settings, Geriatrics, Functional autonomy, Disability
- Medical subject headings
- Syndrome, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of frailty tools in elderly peopleOther
Assessment of the tools as screening/diagnosis instruments in older adults attended in Primary Care. To build the integration of tools in algorithms to be used in each setting of care and along the settings to permit an integrated care in different conditions (isolated assessment or sequential assessment)
| Study group | Role | What they receive |
|---|---|---|
| Hospital Universitario de Getafe | Assessment of frailty tools in elderly people
The Geriatric Department attends patients:
1800/year - acute unit. 800/year - Orthogeriatrics and Interconsultation Unit. 300/year - Day Hospital. 4000/year - Outpatient office. 1200/year - Domiciliary Care. Receives: Other: Assessment of frailty tools in elderly people | |
| Diabetes Frail Ltd. | Assessment of frailty tools in elderly people Has significant experience in managing research studies in older people. Receives: Other: Assessment of frailty tools in elderly people | |
| Università Cattólica del Sacro Cuore | Assessment of frailty tools in elderly people
The Geriatric Unit is compounded by:
24 beds of Acute Care Ward 46 beds of Intensive Rehabilitation Unit 20 beds of Day Hospital Outpatient clinic Receives: Other: Assessment of frailty tools in elderly people | |
| Gérontopole de Toulouse | Assessment of frailty tools in elderly people
The Geriatric Unit is compounded by:
5 Acute Care Units - 100 beds. 3 Rehabilitation Unit - 75 beds. Long term care Unit - 140 beds. 2 Day Hospitals Outpatient Clinic Receives: Other: Assessment of frailty tools in elderly people | |
| Jagiellonian University Medical College | Assessment of frailty tools in elderly people The Department of Internal Medicine and Gerontology is the largest centre in Poland limited to the Geriatric market. Receives: Other: Assessment of frailty tools in elderly people |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
data obtained from the official registration of the country of the corresponding partner. When not available, other methods will be used (asking to a proxy, calls to nursing homes, medical registries, etc.).
Measured: 18 months
Functional disability
Defined as a loss of at least one point in the Short Physical Performance Battery (SPPB).
Measured: 18 months
Disability to perform IADL
Defined as a loss of at least one point in the Lawton Index
Measured: 18 months
Disability to perform BADL
Defined as a loss of at least one point in the Barthel Index.
Measured: 18 months
Falls
Data will be collected by the participant's verbal recall (self-assessed) and will be registered in the electronic Case Report Form (eCRF).
Measured: 18 months
Incident cognitive impairment
Defined by a reduction of 2 or more points in the Mini-Mental State Examination (MMSE).
Measured: 18 months
Secondary outcomes (4)
Frailty classification performance
Performance of the instruments by clinical setting: six frailty assessment tools will be used in four different levels of care. The performance of each scale in the classification of frailty will be established.
Measured: 18 months
Tool feasibility
Composed by two main conditions: the percentage of people that are assessed by each tool in each setting (adequacy) and the time for carrying out the the tool assessment.
Measured: 18 months
Sensitivity to change in frailty status
Evaluate the changes in the assessment level of patients observed at 12 and 18 months with each of the tools and their correlations with the changes observed in the patient´s functional status.
Measured: 18 months
Qualification as a screening and/or diagnosis tool
Evaluate the utility of each scale as a frailty detection method for screening or diagnosis, using pre-established criteria.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startMay 2015
- Primary completionAug 2016 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for SyndromeStudies 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
- Prospective
- Enrolment
- 1,940 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Getafe
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Sponsor
- Investigators
- LEOCADIO RODRIGUEZ MAÑAS, MD, PhD, Principal investigator, HOSPITAL UNIVERSITARIO DE GETAFE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637518
- Sponsor's protocol ID
- 662887
- Acronym
- FRAILTOOLS
- Status last verified
- Aug 2016
- First submitted
- 16 Dec 2015
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
PubMed 11253156Rodriguez-Manas L, Fried LP. Frailty in the clinical scenario. Lancet. 2015 Feb 14;385(9968):e7-e9. doi: 10.1016/S0140-6736(14)61595-6. Epub 2014 Nov 6. No abstract available.
PubMed 25468154Rodriguez-Manas L, Sinclair AJ. Frailty: the quest for new domains, clinical definitions and subtypes. Is this justified on new evidence emerging? J Nutr Health Aging. 2014 Jan;18(1):92-4. doi: 10.1007/s12603-013-0433-9. No abstract available.
PubMed 24402396Garcia-Garcia FJ, Carcaillon L, Fernandez-Tresguerres J, Alfaro A, Larrion JL, Castillo C, Rodriguez-Manas L. A new operational definition of frailty: the Frailty Trait Scale. J Am Med Dir Assoc. 2014 May;15(5):371.e7-371.e13. doi: 10.1016/j.jamda.2014.01.004. Epub 2014 Mar 2.
PubMed 24598478Gill TM, Gahbauer EA, Allore HG, Han L. Transitions between frailty states among community-living older persons. Arch Intern Med. 2006 Feb 27;166(4):418-23. doi: 10.1001/archinte.166.4.418.
PubMed 16505261Fried LP, Guralnik JM. Disability in older adults: evidence regarding significance, etiology, and risk. J Am Geriatr Soc. 1997 Jan;45(1):92-100. doi: 10.1111/j.1532-5415.1997.tb00986.x.
PubMed 8994496Oviedo-Briones M, Rodriguez-Laso A, Carnicero JA, Gryglewska B, Sinclair AJ, Landi F, Vellas B, Rodriguez Artalejo F, Checa-Lopez M, Rodriguez-Manas L. The ability of eight frailty instruments to identify adverse outcomes across different settings: the FRAILTOOLS project. J Cachexia Sarcopenia Muscle. 2022 Jun;13(3):1487-1501. doi: 10.1002/jcsm.12990. Epub 2022 Apr 15.
PubMed 35429109Checa-Lopez M, Oviedo-Briones M, Pardo-Gomez A, Gonzales-Turin J, Guevara-Guevara T, Carnicero JA, Alamo-Ascencio S, Landi F, Cesari M, Grodzicki T, Rodriguez-Manas L; FRAILTOOLS consortium. FRAILTOOLS study protocol: a comprehensive validation of frailty assessment tools to screen and diagnose frailty in different clinical and social settings and to provide instruments for integrated care in older adults. BMC Geriatr. 2019 Mar 18;19(1):86. doi: 10.1186/s12877-019-1042-1.
PubMed 30885132
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Validation of Frailty Assessment Tools to Screen and Diagnose Frailty in Different Clinical and Social Settings and to Provide Instruments for Integrated Care in Older Adults.
- ClinicalTrials.gov ID
- NCT02637518
- Acronym / sponsor ID
- FRAILTOOLS / 662887
- Conditions
- Syndrome
- Keywords
- Frailty, Frailty screening tools, Clinical settings, Social settings, Geriatrics, Functional autonomy, Disability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,940 participants (estimated)
- Lead sponsor
- Hospital Universitario GetafeUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- May 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 22 Dec 2015 (estimated)
- 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.
There is a proved strong evidence of the usefulness of frailty as a predictive factor of relevant and desired outcomes in populations of older adults. Several studies have been published showing the utility of the concept in improving the prognosis accuracy and the prediction of different risks (hospitalisations, surgical and non surgical complications, length of stay, death, incident disability, etc.) in emergency departments, surgical patients, and inpatients with cardiovascular disease. The studies have placed the focus in assessing population risk, while the validation process for these instruments as diagnosis or screening tools has been usually neglected. FRAILTOOLS aims to assess the usefulness as screening and diagnosis tools of some selected instruments to detect frailty in both clinical (Hospital and Primary Care) and social (Nursing Homes) settings, providing diagnostic algorithms clinically sound. Target groups are all of those older adults at risk of frailty (pre-frail) plus those that are frail and are at risk for developing disability. According to the published prevalence of these two conditions, the target population concerned by this project represents around 40-50% of people older than 65, and 60-70% of people older than 75. Once determining the best tools of screening and diagnosis in different settings of care, investigators will research conclusions of these people wherever the level of care they need and currently use. The benefit will spend to the Health System and Social Care as it will provide validated instruments that are necessary to provide an appropriate care for older adults by means of a comprehensive, continued, coordinated and integrated care.
Detailed description
Quality assurance plan:
According to the European's Commission guidelines, the procedure for quality control focuses on the deliverables revision and in the quality of each procedure. The deliverables will be sent to the Administrative committee. The administrative Committee, composed by the Project's Promoter and its associates, will assume the role as a quality manager. It includes the following tasks:
Making sure of the monitoring of all of the changes in documentation. Making sure the activity's coordination and reports are completed according to an adequate quality and in an appropriate manner.
Reviewing the contract deliverables. Monitoring and auditing the project's activities according to plan, making the specific revisions of the contractual deliverables, directed to the achievement of the established objectives.
The electronic Case Report Form (eCRF) has been designed to capture all data required in the protocol. A unique eCRF will be completed for subject, taking into account the protection law in each country of the study.Subjects will be identified by a unique subject number (with key held by the relevant partner), so none identification card number will be recorded on the eCRF or the database. The monitor will guarantee that the eCRF is fully and correctly fill up according to the source documents. The researcher will assure that all data recorded in the eCRF coincide with the information recorded in the source documents.
Plan for missing data to address situations where variables are reported as missing:
The investigators will check the missing data in each eCRF and source documents.
Statistical analysis:
Investigator will assess the associations of each scale with the outcome for each setting and outcome through logistic regressions. First, investigators will compute the classification performance (sensitivity, specificity, Receptors Operational Curve (ROC), Area Under the Curve (AUC), predictive values, likelihood ratios) for each model. Second, investigators will study the feasibility of the models taking into account the time needed for the scale and the percentage of patients that can be assessed per case. Investigators will evaluate the sensitivity to change of the scales and the covariance of the scales with other measures as the SPPB through a mixed linear model.
Sample Size: Participants will be recruited in Spain, Italy, France, United Kingdom and Poland. The total sample will be of 1.940 subjects. Each participating centre will have to recruit a total of 388 patients, corresponding to 97 subjects in each clinical setting by centre.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Hospital Universitario de Getafe | – | Other: Assessment of frailty tools in elderly peopleAssessment of frailty tools in elderly people The Geriatric Department attends patients: 1800/year - acute unit. 800/year - Orthogeriatrics and Interconsultation Unit. 300/year - Day Hospital. 4000/year - Outpatient office. 1200/year - Domiciliary Care. |
| Diabetes Frail Ltd. | – | Other: Assessment of frailty tools in elderly peopleAssessment of frailty tools in elderly people Has significant experience in managing research studies in older people. |
| Università Cattólica del Sacro Cuore | – | Other: Assessment of frailty tools in elderly peopleAssessment of frailty tools in elderly people The Geriatric Unit is compounded by: 24 beds of Acute Care Ward 46 beds of Intensive Rehabilitation Unit 20 beds of Day Hospital Outpatient clinic |
| Gérontopole de Toulouse | – | Other: Assessment of frailty tools in elderly peopleAssessment of frailty tools in elderly people The Geriatric Unit is compounded by: 5 Acute Care Units - 100 beds. 3 Rehabilitation Unit - 75 beds. Long term care Unit - 140 beds. 2 Day Hospitals Outpatient Clinic |
| Jagiellonian University Medical College | – | Other: Assessment of frailty tools in elderly peopleAssessment of frailty tools in elderly people The Department of Internal Medicine and Gerontology is the largest centre in Poland limited to the Geriatric market. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- People older than 75 years old will be included, recruited from different clinical settings such as clinical (hospital or primary care) and social (nursing homes).
Key inclusion criteria (1 listed)
- People older than 75 years old, who sign the informed consent after accepting their participation.
Key exclusion criteria (4 listed)
- General exclusion criteria will be an MMSE score less than 20 points or having a terminal illness (life expectancy < 6 months).
- Subjects included from the hospital ward (Acute Geriatric Unit and Outpatient
- Geriatric Consultation) and primary care will have additional exclusion criteria: dependency in more than 2 Instrumental Activities of Daily Living (IADL) in women (Lawton < 6), and in more than 3 IADL in men (Lawton < 5).
- Subjects seen in a nursing home setting will be excluded if they obtain less than 40 points in the Barthel index.
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 |
|---|---|---|
| Assessment of frailty tools in elderly peopleAssessment of the tools as screening/diagnosis instruments in older adults attended in Primary Care. To build the integration of tools in algorithms to be used in each setting of care and along the settings to permit an integrated care in different conditions (isolated assessment or sequential assessment) | Other | Diabetes Frail Ltd., Gérontopole de Toulouse, Hospital Universitario de Getafe, Jagiellonian University Medical College, Università Cattólica del Sacro Cuore |
Primary outcome
Mortality
Time frame: 18 months
data obtained from the official registration of the country of the corresponding partner. When not available, other methods will be used (asking to a proxy, calls to nursing homes, medical registries, etc.).
Functional disability
Time frame: 18 months
Defined as a loss of at least one point in the Short Physical Performance Battery (SPPB).
Disability to perform IADL
Time frame: 18 months
Defined as a loss of at least one point in the Lawton Index
Disability to perform BADL
Time frame: 18 months
Defined as a loss of at least one point in the Barthel Index.
Falls
Time frame: 18 months
Data will be collected by the participant's verbal recall (self-assessed) and will be registered in the electronic Case Report Form (eCRF).
Incident cognitive impairment
Time frame: 18 months
Defined by a reduction of 2 or more points in the Mini-Mental State Examination (MMSE).
4 secondary outcomes
Frailty classification performance
Time frame: 18 months
Tool feasibility
Time frame: 18 months
Sensitivity to change in frailty status
Time frame: 18 months
Qualification as a screening and/or diagnosis tool
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2016.
- Background: PubMed 11253156Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
- Background: PubMed 25468154Rodriguez-Manas L, Fried LP. Frailty in the clinical scenario. Lancet. 2015 Feb 14;385(9968):e7-e9. doi: 10.1016/S0140-6736(14)61595-6. Epub 2014 Nov 6. No abstract available.
- Background: PubMed 24402396Rodriguez-Manas L, Sinclair AJ. Frailty: the quest for new domains, clinical definitions and subtypes. Is this justified on new evidence emerging? J Nutr Health Aging. 2014 Jan;18(1):92-4. doi: 10.1007/s12603-013-0433-9. No abstract available.
- Background: PubMed 24598478Garcia-Garcia FJ, Carcaillon L, Fernandez-Tresguerres J, Alfaro A, Larrion JL, Castillo C, Rodriguez-Manas L. A new operational definition of frailty: the Frailty Trait Scale. J Am Med Dir Assoc. 2014 May;15(5):371.e7-371.e13. doi: 10.1016/j.jamda.2014.01.004. Epub 2014 Mar 2.
- Background: PubMed 16505261Gill TM, Gahbauer EA, Allore HG, Han L. Transitions between frailty states among community-living older persons. Arch Intern Med. 2006 Feb 27;166(4):418-23. doi: 10.1001/archinte.166.4.418.
- Background: PubMed 8994496Fried LP, Guralnik JM. Disability in older adults: evidence regarding significance, etiology, and risk. J Am Geriatr Soc. 1997 Jan;45(1):92-100. doi: 10.1111/j.1532-5415.1997.tb00986.x.
- Derived from this study: PubMed 35429109Oviedo-Briones M, Rodriguez-Laso A, Carnicero JA, Gryglewska B, Sinclair AJ, Landi F, Vellas B, Rodriguez Artalejo F, Checa-Lopez M, Rodriguez-Manas L. The ability of eight frailty instruments to identify adverse outcomes across different settings: the FRAILTOOLS project. J Cachexia Sarcopenia Muscle. 2022 Jun;13(3):1487-1501. doi: 10.1002/jcsm.12990. Epub 2022 Apr 15.
- Derived from this study: PubMed 30885132Checa-Lopez M, Oviedo-Briones M, Pardo-Gomez A, Gonzales-Turin J, Guevara-Guevara T, Carnicero JA, Alamo-Ascencio S, Landi F, Cesari M, Grodzicki T, Rodriguez-Manas L; FRAILTOOLS consortium. FRAILTOOLS study protocol: a comprehensive validation of frailty assessment tools to screen and diagnose frailty in different clinical and social settings and to provide instruments for integrated care in older adults. BMC Geriatr. 2019 Mar 18;19(1):86. doi: 10.1186/s12877-019-1042-1.
- Individual participant dataSharing planned: Yes
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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.
LEOCADIO RODRIGUEZ MAÑAS, MD, PhD principal investigator
HOSPITAL UNIVERSITARIO DE GETAFE
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 Syndrome, run by Hospital Universitario Getafe 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 24 Aug 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LEOCADIO RODRIGUEZ MAÑAS, MD, PhD (+34 916839360 ext. 2760, leocadio.rodriguez@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 18 months). The study lists 6 primary outcomes in all. 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 NCT02637518, which also lists 8 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 24 Aug 2016.