Older people living with heart failure with preserved ejection fraction and frailty Circulatory System
Conditions
Interventions
The study is called an individually randomised controlled trial with participants being randomly allocated to the control group (usual care only) or the intervention group (usual care plus comprehensi
Sponsors
Bradford Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
65 Years to 110 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 04/11/2025: 1. Aged =65 years 2. Clinical diagnosis of HFpEF* 3. Mild, moderate or severe frailty based on the Clinical Frailty Scale (CFS 5-7) 4. Capacity to provide informed consent (assessed prior to registration) 5. Most recent echocardiogram within the last 2 years and showing LVEF =50% *Diagnosis confirmed by a cardiology specialist. Retrospective identification from clinic letters is a reasonable reference standard as this diagnosis will have been based on guideline standard at the time. Previous inclusion criteria: 1. Aged >= 65 years 2. Clinical diagnosis of HFpEF* 3. Mild, moderate or severe frailty based on the Clinical Frailty Scale (CFS 5-7) 4. Capacity to provide informed consent (assessed prior to registration) *Diagnosis confirmed by a cardiology specialist. Retrospective identification from clinic letters is a reasonable reference standard as this diagnosis will have been based on guideline standard at the time. N.B. As per guidelines LVEF of 40-49% should not be considered eligible.
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 28/01/2025: 1. Not frail (as determined by a score on CFS 1-4); 2. Very severe frailty (CFS 8); 3. Terminally ill with an anticipated life expectancy of < 6 months ; 4. Care home resident; 5. Unstable angina*; 6. New York Heart Association (NYHA) class IV HF (assessed after registration by a CHART researcher); 7. Another household member participating in the trial**; 8. Moderate/severe cognitive impairment (Face-to-face Montreal Cognitive Assessment MoCA score of <18 or Blind Montreal Cognitive Assessment MoCA score of <13) (assessed after registration by a CHART researcher) 9. Significant alternative valvular/structural cardiac disease to explain symptoms***; 10. Current hospitalisation or within the last 3 months with decompensated heart failure 11. Referred or receiving CGA and/or exercise-based rehabilitation as part of a clinical service or another research project****. *A CHART researcher will ask the participant at time of registration whether they have angina and then ask if they have symptoms at rest to determine eligibility. **A CHART researcher will ask the participant at time of registration whether anyone in their household is also participating in CHART. ***Valve disease exclusions include: severe aortic stenosis, severe aortic regurgitation, severe mitral regurgitation, moderate or severe mitral stenosis. Participants with these exclusions will be screened out prior to initial approach for the study. **** Patients referred to or currently being seen in community frailty services, outpatient geriatric medicine services or outpatient/community falls prevention services. A CHART researcher will assess through discussion with the potential participant _____ Previous exclusion criteria: 1. Not frail (as determined by a score on CFS 1-4); 2. Very severe frailty (CFS 8); 3. Terminally ill (CFS 9); 4. Care home resident; 5. Unstable angina*; 6. New York Heart Association (NYHA) class IV HF (assessed after registration by a CHART researcher); 7. Another household member participating in the trial**; 8. Moderate/severe dementia (Montreal Cognitive Assessment MoCA score < 18) (assessed after registration by a CHART researcher); 9. Under regular review from geriatric medicine services; 10. Significant alternative valvular/structural cardiac disease to explain symptoms***; 11. Current hospitalisation with decompensated heart failure 12. Receiving or referred for CGA as part of a clinical service or another research project****. *A CHART researcher will ask the participant at time of registration whether they have angina and then ask if they have symptoms at rest to determine eligibility. **A CHART researcher will ask the participant at time of registration whether anyone in their household is also participating in CHART. ***Valve disease exclusions include: severe aortic stenosis, severe aortic regurgitation, severe mitrial regurgitation, moderate or severe mitral stenosis. Participants with these exclusions will be screened out prior to initial approach for the study. ****Patients seen in community frailty services, outpatient geriatric services, outpatient clinic-based falls services will be screened out prior to study invitation. CHART researchers will do a further check of involvement in these services prior to randomisation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish whether CGA including a 12-week progressive rehabilitation programme (plus usual care) sustains IADL – measured using the Participant reported Nottingham Extended Activities of Daily Living (NEADL) at 12 months post-randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To establish whether the intervention reduces hospitalisation (all-cause; HF-specific; falls; MACCE) and mortality – measured using Hospital Episodes Statistics (HES) / Civil Registrations data at 6-, 12- and 24-months post-randomisation 2. To establish whether the intervention sustains basic ADL, health-related quality of life and mental health – measured using Participant reported NEADL; Barthel Index; EuroQol 5-dimension health questionnaire (EQ5D-5L); Patient Health Questionnaire (PHQ-8); ICEpop CAPability measure for Older People (ICECAP-O) at baseline, 6- and 12-months post-randomisation 3. To establish whether the intervention improves Days alive and out of hospital – measured using Hospital Episodes Statistics (HES) / Civil Registrations data at 6-, 12- and 24-months post-randomisation 4. To establish whether the intervention reduces home care requirement, new care home placement, and overall health/social care resource – measured using Hospital Episodes Statistics (HES) / Civil Registrations data; participant reported health and social care resource use; researcher review of address at 6- and 12-months post-randomisation | — |
Countries
United Kingdom
Contacts
Public ContactHollie Wilkes
Outcome results
None listed