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

NCT06386640 | Recruiting

• 1 other identifier: 0784
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Heart Failure; Frailty

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Phase IIa: Time spent in sedentary, light, moderate and vigorous activity over monitoring duration

  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)

  Measured with Short Physical Performance Battery (SPPB) instrument.

  Up to 6 months

Study Arms (1)

Phase 3 participants

Phase 3 participants

Other: Intervention Development

Interventions

Intervention Development OTHER

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).

Phase 3 participants

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Older adults with frailty and chronic heart failure

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leicester: lead

Study Sites (1)

Glenfield Hospital

Leicester, United Kingdom

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shirley Sze, Dr

CONTACT

0116 252 2673; kyss1@leicester.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: April 26, 2024
• Study Start: January 27, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: April 26, 2024

Record last verified: 2024-03

Locations

GB (1)