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

Frailty Clinical Trial

— FIT-HF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06386640
• Other study ID #: 0784
• Status: Recruiting
• Start date: January 27, 2023
• Est. completion date: April 30, 2025

Study information

• Verified date: March 2024
• Source: University of Leicester
• Contact: Shirley Sze, Dr
• Phone: 0116 252 2673
• Email: kyss1[@]leicester.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Frailty
• Heart Failure

Intervention

Other:
• Intervention 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

Country	Name	City	State
United Kingdom	Glenfield Hospital	Leicester

Sponsors (1)

Lead Sponsor	Collaborator
University of Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase I: Qualitative evaluation with stakeholders to identify gaps in current HF care pathway leading to unmet healthcare needs in older people living with frailty and CHF	Obtained by focus groups and interviews with patients, carers and healthcare professionals.	Up to 6 months
Primary	Phase II: Co-design and production of a holistic, patient-centered intervention addressing various healthcare needs of older people living with frailty and CHF	Obtained by focus groups and interviews with patients, carers and healthcare professionals.	Up to 6 months
Primary	Phase IIa: Time spent in sedentary, light, moderate and vigorous activity over monitoring duration	Measured with accelerometer data.	Up to 6 months
Primary	Phase III: Change in physical function as assessed by the SPPB upon completion of 12-week intervention and at 6 month follow up (this may alter depending on findings from Phase II)	Measured with Short Physical Performance Battery (SPPB) instrument.	Up to 6 months