Frail Elderly SyndromeNCT04139278
The Dynamics of Frailty in Older People
An observational study of Frail Elderly Syndrome, run by University of Southampton at 1 site in United Kingdom.
Trial summary
In the context of reduced resources and rising demand for unplanned care, the delivery of appropriate services to support people with frailty will be key to providing cost-effective, quality care for older people. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Frail Elderly Syndrome
- What is being tested?
- Observational
- How many people
- 300,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Jul 2020to 28 Feb 2022
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Retrospective primary care patient population aged 50 and over in 2006
Who may be able to join
- aged 50 years and above
- registered with participating GP practices between 2006 and 2016
Who cannot join
- aged less than 50 years
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Southampton
Southampton, Hampshire, SO17 1BJ
Bronagh Walsh, PhD, +442380597991, B.M.Walsh@soton.ac.uk
Francesca Lambert, CertHE, 02380595917, F.Lambert@soton.ac.uk
About this study
Official title: The Dynamics of Frailty in Older People: Modelling Impact on Health Care Demand and Outcomes to Inform Service Planning and Commissioning
In the context of reduced resources and rising demand for unplanned care, the delivery of appropriate services to support people with frailty will be key to providing cost-effective, quality care for older people. There is recognition of an evidence gap in relation to the planning, commissioning and delivery of services for older people living with frailty. Questions remain about the incidence and prevalence different levels of frailty and the consequences for health outcomes, health and care service use and costs.
In this study, the investigators will explore the incidence and prevalence, development and impact of frailty within the population using retrospective primary care data on patients aged 50 and over in 2006 within the database. The investigators will stratify the cohort by severity of frailty and explore frailty status over time, determining incidence, prevalence and progression of frailty. The relationships between factors such as age, deprivation, ethnicity, location and comorbidities of individuals in relation to development of, and deterioration in, frailty status will be examined. The influence of frailty on outcomes, service use and costs will be explored. These analyses will be used to inform the development of a prototype simulation model, which will use a System Dynamics (SD) based approach to explore the development and impact of frailty in the population and likely future scenarios over a 10-year timeframe. Finally, 'what if' scenarios developed with the stakeholder engagement group will be explored via simulation modelling.
Read the detailed description
The impact of frailty on demand for and outcomes of care has emerged as a significant issue for the National Health Service (NHS) in recent years. The association between frailty and adverse outcomes such as unplanned admission, transfer to residential care and high service use is well recognised (BGS 2014/15; NIHR 2017; Clegg et al. 2013). As the population ages, prevalence of frailty and associated demand for health care rise. In the context of reduced resources and rising demand for unplanned care, the delivery of appropriate services to support people with frailty will be key to providing cost-effective, quality care for older people. Recent consensus guidelines have emphasised the importance of identification and clinical management of frailty (BGS 2014; NICE 2016) and effective interventions are available, but capacity and resources for delivery are limited. There is recognition of an evidence gap in relation to the planning, commissioning and delivery of services for older people living with frailty (NIHR 2017). Questions remain about the incidence and prevalence different levels of frailty and the consequences for health outcomes, health and care service use and costs. Addressing these issues requires exploration of population trends in the development and impact of frailty, but this research has previously been limited because of the need for clinical assessment for the identification of frailty. The recent introduction of the electronic Frailty Index (eFI) (Clegg et al. 2016) allows routine primary care data to be used to identify the presence and severity of frailty in real-world populations. The eFI therefore facilitates the exploration of the dynamics of frailty and its impact at a population level. It enables stratification of the primary care population into robust, mild, moderate and severe frailty groups, so enabling comparison of trajectories of decline and pathways of care between these groups, which will be key to service development and commissioning.
In this study, the investigators will explore the incidence and prevalence, development and impact of frailty within the population using retrospective data from the Royal College of General Practitioners Research Surveillance Centre (RCGP RSC) database, which holds data for 1.8m patients from 230 practices. The eFI tool will be utilised to stratify a cohort of people aged 60 and over within the database between 2004-8 into robust, mild, moderate and severe frailty groups. Data will be extracted on frailty status, health care use, and outcomes for the subsequent 10 years, calculating key service use costs from these data. Outcomes will include mortality, unplanned hospital admission, Accident and Emergency (A\&E) attendance and General Practitioner (GP) appointments. The RCGP RSC dataset will also provide data on socio-economic factors, practice size and location and residence. The cohort will be stratified by severity of frailty, and frailty status explored over time, determining incidence, prevalence and progression of frailty. The investigators will examine the relationships between factors such as age, deprivation, ethnicity, location and comorbidities of individuals in relation to development of, and deterioration in, frailty status. The influence of frailty on outcomes, service use and costs will be explored. Results from these analyses will be used to inform development of guidelines for service commissioners, developed in partnership with experts in service delivery, commissioning and Public Patient Involvement (PPI) representatives through stakeholder engagement. These analyses will inform the development of a prototype simulation model, which will use a System Dynamics (SD) based approach to explore the development and impact of frailty in the population and likely future scenarios over a 10-year timeframe. The simulation model population projections will be externally validated against retrospective data from the Leeds Data Model (LDM) dataset, which holds data for 810,000 primary care patients from 108 practices in the Leeds area. Residence data from RCGP RSC will be supplemented by data on residential care transitions and social care use by frailty status from the Secure Anonymised Information Linkage (SAIL) Databank, which holds primary and social care data on up to 30,000 individuals in Wales, to inform simulation of impacts and costs beyond the health care setting. Finally, 'what if' scenarios developed with the stakeholder engagement group (SEG) will be explored via simulation modelling.
- Conditions
- Frail Elderly Syndrome
- Being tested
- Observational
- Keywords
- Frail Elderly Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Observational retrospective study
What is being measured
The primary outcome is the main question the study is designed to answer.
electronic Frailty index
Incidence of frailty
Measured: 10 years
Secondary outcomes (3)
Mortality
Deaths
Measured: 10 years
Service use
use of Emergency Department (ED) and primary care services
Measured: 10 years
cost of GP visit, ED attendance, hospital admission etc
Costs of primary and secondary care services
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start21 Jul 2020
- Primary completion28 Feb 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Frail Elderly 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 300,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, University of Surrey, University of Leeds, Swansea University
- Responsible party
- Sponsor
- Investigators
- Bronagh Walsh, PhD, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139278
- Sponsor's protocol ID
- HS&DR16/116/43
- Status last verified
- Dec 2020
- First submitted
- 29 Jul 2019
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data (IPD) with other researchers
Publications
Walsh B, Fogg C, England T, Brailsford S, Roderick P, Harris S, Fraser S, Clegg A, de Lusignan S, Zhu S, Lambert F, Barkham A, Patel H, Windle V. Impact of frailty in older people on health care demand: simulation modelling of population dynamics to inform service planning. Health Soc Care Deliv Res. 2024 Oct;12(44):1-140. doi: 10.3310/LKJF3976.
PubMed 39487824Fogg C, Fraser SDS, Roderick P, de Lusignan S, Clegg A, Brailsford S, Barkham A, Patel HP, Windle V, Harris S, Zhu S, England T, Evenden D, Lambert F, Walsh B; Frailty Dynamics study team. The dynamics of frailty development and progression in older adults in primary care in England (2006-2017): a retrospective cohort profile. BMC Geriatr. 2022 Jan 6;22(1):30. doi: 10.1186/s12877-021-02684-y.
PubMed 34991479
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dynamics of Frailty in Older People: Modelling Impact on Health Care Demand and Outcomes to Inform Service Planning and Commissioning
- ClinicalTrials.gov ID
- NCT04139278
- Acronym / sponsor ID
- HS&DR16/116/43
- Conditions
- Frail Elderly Syndrome
- Keywords
- Frail Elderly Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300,000 participants (estimated)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, University of Surrey, University of Leeds, Swansea University
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 25 Oct 2019 (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.
In the context of reduced resources and rising demand for unplanned care, the delivery of appropriate services to support people with frailty will be key to providing cost-effective, quality care for older people. There is recognition of an evidence gap in relation to the planning, commissioning and delivery of services for older people living with frailty. Questions remain about the incidence and prevalence different levels of frailty and the consequences for health outcomes, health and care service use and costs.
In this study, the investigators will explore the incidence and prevalence, development and impact of frailty within the population using retrospective primary care data on patients aged 50 and over in 2006 within the database. The investigators will stratify the cohort by severity of frailty and explore frailty status over time, determining incidence, prevalence and progression of frailty. The relationships between factors such as age, deprivation, ethnicity, location and comorbidities of individuals in relation to development of, and deterioration in, frailty status will be examined. The influence of frailty on outcomes, service use and costs will be explored. These analyses will be used to inform the development of a prototype simulation model, which will use a System Dynamics (SD) based approach to explore the development and impact of frailty in the population and likely future scenarios over a 10-year timeframe. Finally, 'what if' scenarios developed with the stakeholder engagement group will be explored via simulation modelling.
Detailed description
The impact of frailty on demand for and outcomes of care has emerged as a significant issue for the National Health Service (NHS) in recent years. The association between frailty and adverse outcomes such as unplanned admission, transfer to residential care and high service use is well recognised (BGS 2014/15; NIHR 2017; Clegg et al. 2013). As the population ages, prevalence of frailty and associated demand for health care rise. In the context of reduced resources and rising demand for unplanned care, the delivery of appropriate services to support people with frailty will be key to providing cost-effective, quality care for older people. Recent consensus guidelines have emphasised the importance of identification and clinical management of frailty (BGS 2014; NICE 2016) and effective interventions are available, but capacity and resources for delivery are limited. There is recognition of an evidence gap in relation to the planning, commissioning and delivery of services for older people living with frailty (NIHR 2017). Questions remain about the incidence and prevalence different levels of frailty and the consequences for health outcomes, health and care service use and costs. Addressing these issues requires exploration of population trends in the development and impact of frailty, but this research has previously been limited because of the need for clinical assessment for the identification of frailty. The recent introduction of the electronic Frailty Index (eFI) (Clegg et al. 2016) allows routine primary care data to be used to identify the presence and severity of frailty in real-world populations. The eFI therefore facilitates the exploration of the dynamics of frailty and its impact at a population level. It enables stratification of the primary care population into robust, mild, moderate and severe frailty groups, so enabling comparison of trajectories of decline and pathways of care between these groups, which will be key to service development and commissioning.
In this study, the investigators will explore the incidence and prevalence, development and impact of frailty within the population using retrospective data from the Royal College of General Practitioners Research Surveillance Centre (RCGP RSC) database, which holds data for 1.8m patients from 230 practices. The eFI tool will be utilised to stratify a cohort of people aged 60 and over within the database between 2004-8 into robust, mild, moderate and severe frailty groups. Data will be extracted on frailty status, health care use, and outcomes for the subsequent 10 years, calculating key service use costs from these data. Outcomes will include mortality, unplanned hospital admission, Accident and Emergency (A\&E) attendance and General Practitioner (GP) appointments. The RCGP RSC dataset will also provide data on socio-economic factors, practice size and location and residence. The cohort will be stratified by severity of frailty, and frailty status explored over time, determining incidence, prevalence and progression of frailty. The investigators will examine the relationships between factors such as age, deprivation, ethnicity, location and comorbidities of individuals in relation to development of, and deterioration in, frailty status. The influence of frailty on outcomes, service use and costs will be explored. Results from these analyses will be used to inform development of guidelines for service commissioners, developed in partnership with experts in service delivery, commissioning and Public Patient Involvement (PPI) representatives through stakeholder engagement. These analyses will inform the development of a prototype simulation model, which will use a System Dynamics (SD) based approach to explore the development and impact of frailty in the population and likely future scenarios over a 10-year timeframe. The simulation model population projections will be externally validated against retrospective data from the Leeds Data Model (LDM) dataset, which holds data for 810,000 primary care patients from 108 practices in the Leeds area. Residence data from RCGP RSC will be supplemented by data on residential care transitions and social care use by frailty status from the Secure Anonymised Information Linkage (SAIL) Databank, which holds primary and social care data on up to 30,000 individuals in Wales, to inform simulation of impacts and costs beyond the health care setting. Finally, 'what if' scenarios developed with the stakeholder engagement group (SEG) will be explored via simulation modelling.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective primary care patient population aged 50 and over in 2006
Key inclusion criteria (2 listed)
- aged 50 years and above
- registered with participating GP practices between 2006 and 2016
Key exclusion criteria (1 listed)
- aged less than 50 years
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 |
|---|---|---|
| ObservationalObservational retrospective study | Other | – |
Primary outcome
electronic Frailty index
Time frame: 10 years
Incidence of frailty
3 secondary outcomes
Mortality
Time frame: 10 years
Service use
Time frame: 10 years
cost of GP visit, ED attendance, hospital admission etc
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Derived from this study: PubMed 39487824Walsh B, Fogg C, England T, Brailsford S, Roderick P, Harris S, Fraser S, Clegg A, de Lusignan S, Zhu S, Lambert F, Barkham A, Patel H, Windle V. Impact of frailty in older people on health care demand: simulation modelling of population dynamics to inform service planning. Health Soc Care Deliv Res. 2024 Oct;12(44):1-140. doi: 10.3310/LKJF3976.
- Derived from this study: PubMed 34991479Fogg C, Fraser SDS, Roderick P, de Lusignan S, Clegg A, Brailsford S, Barkham A, Patel HP, Windle V, Harris S, Zhu S, England T, Evenden D, Lambert F, Walsh B; Frailty Dynamics study team. The dynamics of frailty development and progression in older adults in primary care in England (2006-2017): a retrospective cohort profile. BMC Geriatr. 2022 Jan 6;22(1):30. doi: 10.1186/s12877-021-02684-y.
- Individual participant dataSharing planned: No. No plan to share individual participant data (IPD) with other researchers
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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.
Bronagh Walsh, PhD principal investigator
University of Southampton
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 Frail Elderly Syndrome, run by University of Southampton at 1 site in United Kingdom.
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 2 inclusion and 1 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 21 Dec 2020. 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 United Kingdom. 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 Bronagh Walsh, PhD (+442380597991, B.M.Walsh@soton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
electronic Frailty index (time frame: 10 years). 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 NCT04139278, which also lists 2 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 Dec 2020.