Status:

UNKNOWN

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

Lead Sponsor:

University of Leicester

Conditions:

Chronic Heart Failure

Frailty

Eligibility:

All Genders

18-100 years

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 interve...

Eligibility Criteria

Inclusion Criteria:

  • • Participant is willing and able to give informed consent for participation in the study.

    • Male or Female, aged 65 years or above.
    • Diagnosed with CHF for at least 1 year (Signs and symptoms of HF & either LVEF <40% or LVEF ≥40% with evidence of structural cardiac abnormality on echocardiogram including increased left atrial size, LV hypertrophy or impaired LV filling and/or raised natriuretic peptides: B-type natriuretic peptide (BNP) <35 pg/mL/ N-terminal pro-B-type natriuretic peptide (NT-proBNP) <125 pg/mL)
    • CFS ≥5
    • Willing to actively engage in a 12-week intervention developed by our team targeting older people with frailty and CHF
    • Willing to wear a wrist accelerometer for 7 days before the intervention as well as during the 12-week intervention to assess physical activity profile and monitor adherence to exercise programme
    • Willing to comply with all study requirements.
    • Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study
    • Willing to provide feedback regarding the intervention in the form of interview/ focus groups/ surveys to help refine the intervention
    • Willing for audio recordings or note taking to take place during interviews/ focus groups

Exclusion Criteria:

  • • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study.

    • Significant cognitive impairment that affects the participant's ability to adhere to intervention.
    • Recent wrist fracture or operation that affects the participant's ability to wear a wrist accelerometer
    • Recent injury or operations that would significantly reduce the participants ability to engage in their normal daily activities
    • Participants who are currently recruited into another research study involving a lifestyle intervention
    • Participants who are undergoing major operations during the 12-week intervention
    • Participants unable to give informed consent

Key Trial Info

Start Date :

January 27 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

April 30 2025

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT06386640

Start Date

January 27 2023

End Date

April 30 2025

Last Update

April 26 2024

Active Locations (1)

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1

Glenfield Hospital

Leicester, United Kingdom