NCT06386640

A Holistic Patient-centred Intervention to Improve Outcomes of Older People Living With Frailty and Chronic Heart Failure

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University of Leicester · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Heart Failure
• Frailty

Interventions

Type	Name	Description
OTHER	Intervention Development	Phase I: Research to inform intervention design, Phase II: Co-design and production of intervention with relevant stakeholders, Phase IIa: Physical activity accelerometer data collection and analysis to develop an individualised rehabilitation programme, Phase III: Pilot and refine the intervention across to two NHS sites (University Hospitals of Leicester NHS Trust, Portsmouth Hospitals University NHS Trust).

Timeline

• Start date: 2023-01-27
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2024-04-26
• Last updated: 2024-04-26

Locations

1 site across 1 country: United Kingdom