Loading clinical trials...

A Holistic Patient-centred Intervention to Improve Outcomes of Older People Living With Frailty and Chronic Heart Failure | Clinical Trials | Clareo Health

RECRUITING

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

NCT06386640•University of Leicester

View on ClinicalTrials.gov

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 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.

Eligibility

Age

18 - 100 years

Sex

ALL

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

Locations (1)

Glenfield Hospital

Leicester, United Kingdom

Key Dates

Start Date

January 27, 2023

Primary Completion Date

April 30, 2025

Completion Date

April 30, 2025

Last Updated

April 26, 2024

Enrollment

100

ESTIMATED participants

Conditions

Chronic Heart FailureFrailty

Interventions

Intervention Development

OTHER

Contacts

Shirley Sze, Dr

CONTACT

0116 252 2673 kyss1@leicester.ac.uk

MultidISciplinary Care paThway tailoRed on frAilty in Cancer Patients Referred to Outpatient paLliative Care

NCT07469761

Palliative CarePalliative Care, Health Services+5 more

View study

RECRUITINGNA

Strength-based Tailored-Exercise Program at Home for Geriatric Patients

NCT06820021

FrailtyGeriatrics

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 26, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

MultidISciplinary Care paThway tailoRed on frAilty in Cancer Patients Referred to Outpatient paLliative Care

Strength-based Tailored-Exercise Program at Home for Geriatric Patients

Precision Medicine and Physical Function

Implementation of the Personalized Care Plan (PCP) Proposed at the End of Step 2 of the ICOPE Program

FAXAGE: Fasting And Exercise To Slow Aging In Humans

Inpatient Post-Acute Rehabilitation For Patients in the Midwest: a Prospective Cohort Study of Clinical Characteristics and Process Outcomes