Clinical Trial

Heart Failure Carer Support Programme: Implementation Testing in the UK.

Study acronym: HELP
Recruiting
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Summary
Background: Heart failure (HF) is widespread in the United Kingdom (UK). Many of these patients rely on support from family carers who are ill-prepared and supported for this role. These carers often experience poor mental and physical health because of their caring role. HEart faiLure carer support Programme (HELP) is the first intervention in the UK developed with carers of patients with HF to support them with looking after themselves and the patients they care for. Aim: To identify the best way of delivering HELP to all carers across the UK and evaluate its impact on carers and patients. Methods: HF Nurses will deliver HELP across 3 sites in the UK to approximately 180 carers of patients with HF. The carers targeted will be those who require additional support (caring for a patient who has HF symptoms). These carers will be nominated for the project by patients identified by nurses at in- and out-patient HF appointments. These patients (around 180) will also be invited to provide information for the project. HELP includes 6 online educational support sessions (1 hour each) delivered weekly, along with an educational booklet and website that provide additional support and advice. We will evaluate the impact of HELP on outcomes for patients (i.e., hospital admissions, GP visits, and quality of life) and carers (i.e., burden, preparedness, and quality of life). Interviews and logs / questionnaires will be completed by participants and staff, which will help us understand how best to deliver HELP. Information for the project will be collected at baseline, during HELP, immediately post-HELP (6 weeks), and 6 months after finishing HELP. Impact: The findings will allow us to develop a plan for giving HELP to all carers throughout the UK to provide them with the education and support they need.
Protocol Amendment History 4 changes
critical Recruitment opened 2026-06-03
notable Trial sites expanded: 0 -> 5 locations 2026-06-03
notable Primary completion pushed: 2027-08-01 -> 2027-11-29 2026-06-03
minor Completion pushed: 2027-09-01 -> 2027-11-29 2026-06-03
Trial Details
NCT Number NCT07373041
Lead Sponsor Queen's University, Belfast
Collaborators: Belfast Health and Social Care Trust, Southern Health and Social Care Trust, South Eastern Health and Social Care Trust, King's College Hospital NHS Trust, Glasgow Royal Infirmary
Conditions Heart Failure, Care Givers, Self Management
Enrollment 360 participants
Start Date 2026-05-29
Primary Completion 2027-11-29 (estimated)
Study Completion 2027-11-29 (estimated)
Updated on ClinicalTrials.gov 2026-06-02