NCT04139278 is a clinical trial of Observational in Frail Elderly Syndrome, sponsored by University of Southampton.

Who is sponsoring NCT04139278?

NCT04139278 is sponsored by University of Southampton.

What drugs are being tested in NCT04139278?

Interventions in NCT04139278: Observational.

What condition does NCT04139278 study?

NCT04139278 studies Frail Elderly Syndrome.

Is NCT04139278 still recruiting?

NCT04139278 is currently status unknown. Last updated 21 December 2020.

Last reviewed 2020-12-21 · How we verify

NCT04139278

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Dynamics of Frailty in Older People

Status unknown Last updated 21 December 2020

What this trial tests

trial testing Observational in Frail Elderly Syndrome in 300,000 participants. Status unknown.

Timeline

21 July 2020

Primary endpoint
28 February 2022

28 February 2022

Quick facts

Lead sponsor	University of Southampton
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	300,000
Start date	21 July 2020
Primary completion	28 February 2022
Estimated completion	28 February 2022
Sites	1 location across United Kingdom

Drugs / interventions tested

Observational — full drug profile →

Conditions studied

Frail Elderly Syndrome — all drugs for Frail Elderly Syndrome →

Sponsor

University of Southampton

Who can join

50 and older, any sex, with Frail Elderly Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

The dynamics of frailty development and progression in older adults in primary care in England (2006-2017): a retrospective cohort profile.
Fogg C, Fraser SDS, Roderick P, de Lusignan S, et al · · 2022 · cited 34× · PMID 34991479 · DOI 10.1186/s12877-021-02684-y
Impact of frailty in older people on health care demand: simulation modelling of population dynamics to inform service planning.
Walsh B, Fogg C, England T, Brailsford S, et al · · 2024 · cited 8× · PMID 39487824 · DOI 10.3310/lkjf3976
The Dynamics of Frailty Development and Progression in Older Adults in England (2006 – 2017): A Retrospective Cohort Profile
Fogg C, Fraser SD, Roderick P, Lusignan S, et al · · 2021 · DOI 10.21203/rs.3.rs-547404/v1

Verify or expand the search:

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Trials testing the same drug.

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Other recruiting trials for Frail Elderly Syndrome

Currently open trials in the same condition.

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NCT06444321 — INTEgRated Health CARE for Patients With Frailty and Heart Failure · NA · recruiting
NCT05993754 — Non-pharmacological Prevention of POD in Frailty Elderly Undergoing Elective Surgery Applied by Nursing Teams · NA · recruiting
NCT06496022 — Comparative Analysis of Risk Factors and Prediction of Frailty Syndrome · active not recruiting

Other University of Southampton trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04139278 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Southampton
Last refreshed: 21 December 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04139278.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing