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

University of Leicester

Status

Enrolling

Conditions

Chronic Heart Failure

Frailty

Treatments

Other: Intervention Development

Study type

Observational

Funder types

Other

Identifiers

NCT06386640

0784

Details and patient eligibility

About

Two-centre complex intervention development and feasibility trial using mixed qualitative and quantitative approach

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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