RecruitingNCT06386640
A Holistic Patient-centred Intervention to Improve Outcomes of Older People Living With Frailty and Chronic Heart Failure
Sponsor
University of Leicester
Enrollment
100 participants
Start Date
Jan 27, 2023
Study Type
OBSERVATIONAL
Conditions
Summary
Two-centre complex intervention development and feasibility trial using mixed qualitative and quantitative approach
Eligibility
Min Age: 18 YearsMax Age: 100 Years
Inclusion Criteria10
- • 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 Criteria7
- • 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
Interventions
OTHERIntervention 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).
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06386640
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