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

April 23, 2024 updated by: University of Leicester
Two-centre complex intervention development and feasibility trial using mixed qualitative and quantitative approach

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Older adults with frailty and chronic heart failure

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Phase 3 participants
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Up to 6 months
Obtained by focus groups and interviews with patients, carers and healthcare professionals.
Up to 6 months
Phase II: Co-design and production of a holistic, patient-centered intervention addressing various healthcare needs of older people living with frailty and CHF
Time Frame: Up to 6 months
Obtained by focus groups and interviews with patients, carers and healthcare professionals.
Up to 6 months
Phase IIa: Time spent in sedentary, light, moderate and vigorous activity over monitoring duration
Time Frame: Up to 6 months
Measured with accelerometer data.
Up to 6 months
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)
Time Frame: Up to 6 months
Measured with Short Physical Performance Battery (SPPB) instrument.
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leicester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2023

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

April 7, 2024

First Submitted That Met QC Criteria

April 23, 2024

First Posted (Actual)

April 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0784

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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