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

Sponsor: Queen's University, Belfast

NCT ID: NCT07373041

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
HEart faiLure carer support Programme (HELP) (behavioural)
How long the study runs
Study runs about 18 months (dates as stated)
About the drug or intervention
HEart faiLure carer support Programme (HELP) — behavioural: A 6-week, psychoeducational intervention consisting of two components: 1) Online support group sessions and 2) Educational booklet and supplementary website.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
360
Started
2026-05-29
Last checked
2026-05

Plain English Summary

What is this study?

  • • Testing a new treatment for heart failure
  • • NA - 360 participants
  • • Background: Heart failure (HF) is widespread in the United Kingdom (UK)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with heart failure

Where?

  • • Belfast - Royal Victoria Hospital
  • • Belfast - Ulster Hospital
  • • Craigavon - Craigavon Area Hospital
  • • Glasgow - Glasgow Royal Infirmary
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Heart FailureCare GiversSelf Management

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Carers
  • ✓Inclusion Criteria
  • ✓Aged 18 years or older
  • ✓Physical and mental ability to operate a digital device, engage comfortably in conversation with peers, and be able...
  • ✓Ability to speak and understand English
See the full criteria
Carers Inclusion Criteria 1. Aged 18 years or older 2. Physical and mental ability to operate a digital device, engage comfortably in conversation with peers, and be able to read written materials 3. Caring (regular, unpaid care) for a person with a clinical diagnosis of heart failure (HF) who is receiving standard evidence-based HF therapies and has either HF symptoms or 1 episode of decompensation (symptoms requiring medical attention) in previous 6 months 4. Ability to speak and understand English Exclusion criteria 1. Lacking capacity to give consent 2. Under the age of 18 Patients Inclusion Criteria 1. Aged 18 years or older 2. Physical and mental ability to engage comfortably in conversation and be able to read written materials 3. Clinical diagnosis of HF and receiving standard evidence-based HF therapies and has either HF symptoms or 1 episode of decompensation (symptoms requiring medical attention) in previous 6 months 4. Ability to speak and understand English 5. Receiving regular, unpaid support with managing his / her condition from a loved one or friend (e.g., a relative or spouse) Exclusion criteria 1. Lacking capacity to give consent 2. Under the age of 18 3. Carer refused to participate in HELP

Where Is This Study? (5 UK sites)

Royal Victoria Hospital

Belfast, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)

Ulster Hospital

Belfast, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)

Craigavon Area Hospital

Craigavon, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)

Glasgow Royal Infirmary

Glasgow, United Kingdom

Recruiting
Site contact (verified)

King's College Hospital

London, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)

How to Get in Touch

Gareth Thompson, PhD

Sponsor contact

CONTACT

07714198795 gareth.thompson@qub.ac.uk

Donna Fitzsimons, PhD, RN

Sponsor contact

CONTACT

D.Fitzsimons@qub.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-05