Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID07373041

Implementation Testing of the Heart Failure Carer Support Programme in the United Kingdom

Led by Queen's University, Belfast · Updated on 2026-06-02

360

Participants Needed

5

Research Sites

N/A

Total Duration

On this page

Sponsors

Q

Queen's University, Belfast

Lead Sponsor

B

Belfast Health and Social Care Trust

Collaborating Sponsor

AI-Summary

What this Trial Is About

Heart failure is a common condition in the United Kingdom, where many patients depend on family members or friends to help care for them. These caregivers often face challenges and stress due to their role, which can affect their own mental and physical health. The Heart Failure Carer Support Programme (HELP) is the first intervention developed in the UK to support these carers by helping them care for themselves and the patients they assist. The study aims to find the best way to provide HELP across the UK and measure its effects on both carers and patients. HELP is delivered by heart failure nurses to about 180 informal carers across three UK locations. The programme consists of six weekly online support group sessions lasting one hour each, led by specialist nurses via video calls. Carers also receive an educational booklet and access to a website for additional guidance. Patients supported by these carers, also around 180 individuals, will provide information to assess how HELP affects both carers and patients over time. Participants will provide information at different times: before the programme starts, during the six weeks of HELP, immediately after finishing, and six months later. Researchers will collect data through interviews, logs, and questionnaires to understand how well HELP is delivered and what factors influence its success. They will also measure hospital admissions, doctor visits, and quality of life for patients, as well as burden, preparedness, and quality of life for carers. The study will last up to one year, including monitoring costs and long-term effects.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Carers aged 18 years or older
  • Able to use digital devices, participate in conversations, and read written materials
  • Providing regular unpaid care for a person with diagnosed heart failure who has symptoms or had a medical episode in the past 6 months
  • Able to speak and understand English
  • Patients aged 18 years or older
  • Diagnosed with heart failure and receiving standard therapies
  • Experiencing symptoms or had one episode of decompensation in the past 6 months
  • Receiving regular unpaid support from a carer
  • Able to engage in conversation and read written materials
  • Able to speak and understand English
Not Eligible

You will not qualify if you...

  • Lacking capacity to give consent
  • Under 18 years old
  • Patients whose carer refused to participate in the programme

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or virtual) for eligibility assessment

Outpatient Treatment

Duration - 6 weeks

Participants engage in a 6-week psychoeducational support programme consisting of weekly online group support sessions and self-directed learning through educational materials.

Weekly online support group sessions via ZOOM

Follow-up

Duration - Up to 6 months after treatment

Participants are followed for up to 6 months to assess experiences, behavioural impacts, and long-term adherence to the support programme.

Assessments at baseline, 6 weeks, and 6 months with additional weekly perspectives collected during the 6-week programme

Trial Site Locations

Total: 5 locations

1

Royal Victoria Hospital

Belfast, United Kingdom

Not Yet Recruiting

2

Ulster Hospital

Belfast, United Kingdom

Not Yet Recruiting

3

Craigavon Area Hospital

Craigavon, United Kingdom

Not Yet Recruiting

4

Glasgow Royal Infirmary

Glasgow, United Kingdom

Actively Recruiting

5

King's College Hospital

London, United Kingdom

Not Yet Recruiting

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Research Team

G

Gareth Thompson, PhD

D

Donna Fitzsimons, PhD, RN

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

Evaluating the implementation and impact of the HEart faiLure carer support Programme (HELP) in the United Kingdom: A study protocol for a multi-centre, mixed-method, implementation study.

Gareth Thompson, Judy Bradley, Martin Dempster...

https://pubmed.ncbi.nlm.nih.gov/41996443