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NCT Number: NCT07373041

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Care Givers Heart Diseases Self Management

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Victoria Hospital, Belfast, United Kingdom

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 to read written materials
  • 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
  • Ability to speak and understand English

Exclusion criteria

  • Lacking capacity to give consent
  • Under the age of 18

Patients

Inclusion criteria

  • Aged 18 years or older
  • Physical and mental ability to engage comfortably in conversation and be able to read written materials
  • 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
  • Ability to speak and understand English
  • Receiving regular, unpaid support with managing his / her condition from a loved one or friend (e.g., a relative or spouse)

Exclusion criteria

  • Lacking capacity to give consent
  • Under the age of 18
  • Carer refused to participate in HELP

Treatment and study plan

HEart faiLure carer support Programme (HELP)

Behavioral

A 6-week, psychoeducational intervention consisting of two components: 1) Online support group sessions and 2) Educational booklet and supplementary website. A weekly online support group session will be delivered over 6 weeks via ZOOM by local specialist heart failure nurses. Each session will consist of 12 carers and last approximately 60 minutes. The sessions will initiate with a presentation (approximately 20 minutes in duration) on the allocated topic, including questions and group discussions throughout.

Carers will complete self-directed learning across the educational booklet and website, which will complement the support group sessions.

Primary outcomes

  1. Participant-reported experiences of fidelity of HELP implementation assessed by semi-structured interviews following a study-specific topic guide.

    Time frame: 6 months

    Semi-structured, audio-recorded interviews will be conducted with participants (carers, patients, and healthcare professionals). The study-specific interview guide will include open-ended questions exploring: 1) Study Design, 2) Provider Training, 3) Intervention Delivery, 4) Treatment Receipt, and 5) Enactment. Interviews will be conducted via a telephone call (approximately 45-60 minutes in duration). Interviews will be transcribed verbatim and analysed with adaptive framework analysis.

  2. Participant-reported experiences of contextual factors influencing HELP implementation assessed by semi-structured interviews following a study-specific topic guide.

    Time frame: 6 months

    Semi-structured, audio-recorded interviews will be conducted with participants (carers, patients, and healthcare professionals). The study-specific interview guide will include open-ended questions exploring barriers and facilitators to HELP implementation. Interviews will be conducted via a telephone call (approximately 45-60 minutes in duration). Interviews will be transcribed verbatim and analysed with adaptive framework analysis.

  3. Cost of HELP implementation.

    Time frame: Baseline to 1 year

    The economic cost of HELP implementation in the UK will be estimated via the collection of data detailing training costs and time input for supervision of HELP facilitators, along with Facilitator logs each session documenting time, expenditure, resources required, and adaptations made for individual carers.

Secondary outcomes

  1. Change in score from baseline in Zarit Burden Interview, Short Form

    Time frame: Baseline, 6 weeks, and 6 months

    Completed by carers.

  2. Change in score from baseline in Preparedness for Caregiving Scale

    Time frame: Baseline, 6 weeks, and 6 months

    Completed by carers

  3. Change in score from baseline in 12-Item Short Form Survey

    Time frame: Baseline, 6 weeks, and 6 months

    Completed by carers

  4. Change in score from baseline in Hospital Anxiety and Depression Scale

    Time frame: Baseline, 6 weeks, and 6 months

    Completed by carers

  5. Change in score from baseline in Perceived Stress Scale

    Time frame: Baseline, 6 weeks, and 6 months

    Completed by carers

  6. Change in score from baseline in Multidimensional Scale of Perceived Social Support

    Time frame: Baseline, 6 weeks, and 6 months

    Completed by carers

  7. Change in score from baseline in Minnesota Living with Heart Failure Questionnaire

    Time frame: Baseline, 6 weeks, and 6 months

    Completed by patients

  8. Change in score from baseline in EuroQol Five Dimension Questionnaire

    Time frame: Baseline, 6 weeks, and 6 months

    Completed by patients

  9. Number of hospital admissions and GP visits with reasons over previous 6 months

    Time frame: Baseline and 6 months

    For patients

  10. Perspectives on how HELP has influenced behaviour

    Time frame: Week 1, week 2, week 3, week 4, week 5, and week 6

    Data collected via bespoke questionnaires completed by carers and patients

  11. Perspectives on long-term adherence to support provided by HELP

    Time frame: 6 months

    Collected via a questionnaire completed by carers and patients

Study contacts

Contact information is provided by the study sponsor or research team.

Donna Fitzsimons, PhD, RN

CONTACT

[email protected]

Gareth Thompson, PhD

CONTACT

[email protected]

07714198795

Sponsors and collaborators

Lead sponsor

Queen's University, Belfast

Other

Collaborators

  • Belfast Health and Social Care Trust
  • Glasgow Royal Infirmary
  • King's College Hospital NHS Trust
  • South Eastern Health and Social Care Trust
  • Southern Health and Social Care Trust

Registry information

Official study title

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

Acronym: HELP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 28, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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