Holistic intervention to improve outcomes for older patients with heart failure and frailty
A Holistic Patient-centred Intervention to Improve Outcomes of Older People Living With Frailty and Chronic Heart Failure
University of Leicester · NCT06386640
This study is testing a new, all-around approach to help older adults with heart failure and frailty feel better and improve their health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Leicester (other) |
| Locations | 1 site (Leicester) |
| Trial ID | NCT06386640 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop and test a holistic, patient-centered intervention for older adults living with chronic heart failure (CHF) and frailty. The research will be conducted in three stages: first, background research will inform the intervention design; second, the intervention will be co-designed with stakeholders; and third, the developed intervention will be trialed in a multicenter setting, with feedback collected for refinement. A combination of qualitative and quantitative methods will be utilized to assess the intervention's effectiveness and feasibility.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 65 and older, diagnosed with chronic heart failure for at least one year, and exhibiting signs of frailty.
Not a fit: Patients who are younger than 65 or do not have a diagnosis of chronic heart failure or frailty may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could improve physical function and quality of life for patients with CHF while reducing hospitalizations and healthcare costs.
How similar studies have performed: Other studies have shown promise with similar holistic approaches, indicating potential for success in this intervention.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Leicester
- Glenfield Hospital — Leicester, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Shirley Sze, Dr
- Email: kyss1@leicester.ac.uk
- Phone: 0116 252 2673
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Heart Failure, Frailty