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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Bronagh Walsh, PhD contact

+442380597991

B.M.Walsh@soton.ac.uk

Francesca Lambert contact

02380595917

F.Lambert@soton.ac.uk

United Kingdom1 site, 1 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

    Recruiting

Other trials in United Kingdom

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.

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.

  1. electronic Frailty index

    Incidence of frailty

    Measured: 10 years

Secondary outcomes (3)
  1. Mortality

    Deaths

    Measured: 10 years

  2. Service use

    use of Emergency Department (ED) and primary care services

    Measured: 10 years

  3. 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.

  1. First posted25 Oct 2019
  2. Study start21 Jul 2020
  3. Primary completion28 Feb 2022 (estimated)
  4. Study completion28 Feb 2022 (estimated)

Resources

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)
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 39487824
  • Fogg 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

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.

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