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