Viewing Study NCT06386640



Ignite Creation Date: 2024-05-06 @ 8:26 PM
Last Modification Date: 2024-10-26 @ 3:28 PM
Study NCT ID: NCT06386640
Status: RECRUITING
Last Update Posted: 2024-04-26
First Post: 2024-04-07

Brief Title: A Holistic Patient-centred Intervention to Improve Outcomes of Older People Living With Frailty and Chronic Heart Failure
Sponsor: University of Leicester
Organization: University of Leicester

Study Overview

Official Title: A Holistic Patient-centred Intervention to Improve Outcomes of Older People Living With Frailty and Chronic Heart Failure
Status: RECRUITING
Status Verified Date: 2024-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: FIT-HF
Brief Summary: Two-centre complex intervention development and feasibility trial using mixed qualitative and quantitative approach
Detailed Description: The intervention will be developed and its effectiveness and feasibility tested via 3 stages Stage1 Relevant background research will be performed to inform intervention design stage 2 the intervention will be co-designed with relevant stakeholders and stage 3 the developed intervention will be trialled in a multicentre setting and feedback obtained from stakeholders to refine the intervention A mixture of qualitative and quantitative methods will be used in this project

The trial hypothesises that the holistic person-centred frailty-attuned intervention will benefit CHF patients not only in terms of improved physical function but also QoL and reduce hospitalisations This might also reduce NHS costs associated with managing adverse outcomes of at-risk patients On the wider level the intervention could potentially improve the care and outcomes in patients with CHF nationally and internationally

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None