Comprehensive geriatric assessment to sustain independence for older people living with heart failure with preserved ejection fraction and frailty

Aim

To establish whether CGA (plus usual care) is a clinically and cost-effective intervention to sustain independence in instrumental activities of daily living (IADL) for older people with HFpEF and frailty when compared with usual care alone. Methods Design

Pragmatic, multicentre, individually randomised, parallel group RCT with internal pilot and embedded process and cost-effectiveness evaluations. Setting/recruitment Multimodal recruitment strategy to maximise participant pool: 1) Screening in secondary care HF services. 2) Via the national HFpEF registry.

Recruitment from 17 sites across 3 hubs (North West, Yorkshire & Humber, South West). Inclusion criteria

Older adults aged >65-years with HFpEF and mild, moderate or severe frailty based on the Clinical Frailty Scale (CFS, categories 5-7). Intervention

Geriatrician-led CGA using a structured tool, with tailored management plan and follow-up, including a 12-week progressive rehabilitation programme, plus usual care. Control Usual care. Randomisation

Individually randomised in a 1.43:1 allocation ratio (intervention:control) to account for partially nested trial design. Measurement of outcomes/costs

From baseline assessment, postal follow-up at 6 & 12 months, supported with telephone/face-to-face follow-up; routine healthcare data (HES) and mortality (Civil Registrations). Follow-up to 24 months via routine data. Primary outcome

Nottingham Extended Activities of Daily Living (NEADL) index - a validated measure of help needed with IADL, aligned with the commissioning brief. Key secondary outcomes from routine HES & Civil Registrations at 6, 12 & 24 months Hospitalisation (all-cause; HF-specific; falls; Major Adverse Cardiac and Cerebrovascular Events (MACCE))

Mortality Secondary outcomes at 6 & 12 months

Modified Barthel Index; EQ5D-5L; 8-item Patient Health Questionnaire; days alive and out of hospital (DAOH); home care requirement; new care home placement; health/social care resource use; cost-effectiveness. Sample size

433 participants (178 control, 255 intervention) will provide 90% power to detect a minimum effect size of 0.4 equating to a difference of 5.5 points on the 66-point NEADL. Analysis

Primary analysis will compare mean NEADL scores between groups using a random-effects model to account for clustering in the intervention arm, adjusted for the stratification factors and participant covariates. Internal pilot

At least 9 sites, including 4 existing HFpEF registry sites and 5 additional sites including areas of high socioeconomic deprivation and high disease burden. Progression criteria (recruitment/intervention adherence) will be assessed after 9 months of recruitment. Health economic evaluation

We will assess cost-effectiveness using within-trial analysis and a Decision Analytic Model with a life-time perspective. Analysis will consider outcomes from the traditional health perspective (health-QALYs) using EQ5D-5L. Process evaluation

We will use qualitative methods to evaluate the experiences of receiving or delivering the intervention and finalise the intervention theory to inform ‘real-world’ NHS delivery. Timelines

Total 58m. Set-up 1-9m; recruitment 10-28m (2 participants/site/month, staggered site opening); 12m follow-up 22-40m; 24m follow-up 34-52m; analysis/final report 53-58m.