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

Queen's University Belfast

Status: Begins enrollment this month

Conditions: Care Givers; Heart Failure; Self Management

Treatments: Behavioral: HEart faiLure carer support Programme (HELP)

Study type: Interventional

Funder types: Other

Identifiers

NCT07373041

B25/04

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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360 participants in 2 patient groups

Carers

Experimental group

Description:

180 informal carers of people with symptomatic heart failure across the three collaborating centres (Northern Ireland, England, and Scotland). These carers will receive the HEart faiLure carer support Programme (HELP).

Treatment:

Behavioral: HEart faiLure carer support Programme (HELP)

Patients with symptomatic heart failure

No Intervention group

Description:

The patients who are receiving support from the recruited carers will be invited to provide outcome data (approximately 180), which will enable an assessment of the dyadic impact of HELP.