NCT04139278

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 25, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

July 21, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

December 21, 2020

Status Verified

December 1, 2020

Enrollment Period

1.6 years

First QC Date

July 29, 2019

Last Update Submit

December 18, 2020

Conditions

Frail Elderly Syndrome

Keywords

Frail Elderly Syndrome

Outcome Measures

Primary Outcomes (1)

  • electronic Frailty index

    Incidence of frailty

    10 years

Secondary Outcomes (3)

  • Mortality

    10 years

  • Service use

    10 years

  • cost of GP visit, ED attendance, hospital admission etc

    10 years

Interventions

ObservationalOTHER

Observational retrospective study

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Retrospective primary care patient population aged 50 and over in 2006

You may qualify if:

  • aged 50 years and above
  • registered with participating GP practices between 2006 and 2016

You may not qualify if:

  • aged less than 50 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southampton

Southampton, Hampshire, SO17 1BJ, United Kingdom

RECRUITING

Related Publications (2)

  • 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.

    PMID: 39487824DERIVED

  • 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.

    PMID: 34991479DERIVED

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Bronagh Walsh, PhD

    University of Southampton

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bronagh Walsh, PhD

CONTACT

+442380597991B.M.Walsh@soton.ac.uk

Francesca Lambert

CONTACT

02380595917F.Lambert@soton.ac.uk

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2019

First Posted

October 25, 2019

Study Start

July 21, 2020

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

December 21, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

No plan to share individual participant data (IPD) with other researchers

Locations

GB(1)