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| Name | Class |
|---|---|
| Belfast Health and Social Care Trust | OTHER |
| Southern Health and Social Care Trust | OTHER_GOV |
| South Eastern Health and Social Care Trust | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carers | Experimental | 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). |
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| Patients with symptomatic heart failure | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant-reported experiences of fidelity of HELP implementation assessed by semi-structured interviews following a study-specific topic guide. | 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. | 6 months |
| Participant-reported experiences of contextual factors influencing HELP implementation assessed by semi-structured interviews following a study-specific topic guide. | 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. | 6 months |
| Cost of HELP implementation. | 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. | Baseline to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in score from baseline in Zarit Burden Interview, Short Form | Completed by carers. | Baseline, 6 weeks, and 6 months |
| Change in score from baseline in Preparedness for Caregiving Scale | Completed by carers |
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Carers
Inclusion Criteria
Exclusion criteria
Patients
Inclusion Criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gareth Thompson, PhD | Contact | 07714198795 | gareth.thompson@qub.ac.uk | |
| Donna Fitzsimons, PhD, RN | Contact | D.Fitzsimons@qub.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Victoria Hospital | Not yet recruiting | Belfast | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41996443 | Derived | Thompson G, Bradley J, Dempster M, Stark P, Clarke M, Johnston N, Dixon L, Campbell P, Donnelly P, McDonagh T, Piper S, Millerick Y, Hill L, Fitzsimons D. 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. PLoS One. 2026 Apr 17;21(4):e0347037. doi: 10.1371/journal.pone.0347037. eCollection 2026. |
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Consent will be obtained from participants for data preservation and sharing in an anonymised format. As per the QUB Research Data Management Policy [https://www.qub.ac.uk/directorates/InformationServices/TheLibrary/CustomerService/PoliciesandRegulations/ResearchDataManagementPolicy/\], data will be retained in an anonymised format for a minimum of 5 years following publication if they are of continuing value to the researchers and the wider research community. Upon project completion, data sets will be allocated a DOI and transferred to QUB's research information management system (Pure) for long-term preservation, which will contain links to the project and relevant publications. All data that may identify participants will be destroyed following QUB procedures. Data will be exclusive to the team until project completion. After which, data may be shared in an anonymised format with participant consent.
With participant consent, data sets will be shared following project completion (approximately December 2027). These data sets will be retained by QUB indefinitely.
Data will be exclusive to the team until project completion. After which, any data collected may be shared in an anonymised format with participant consent.
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| King's College Hospital NHS Trust |
| OTHER |
| Glasgow Royal Infirmary | OTHER |
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| Baseline, 6 weeks, and 6 months |
| Change in score from baseline in 12-Item Short Form Survey | Completed by carers | Baseline, 6 weeks, and 6 months |
| Change in score from baseline in Hospital Anxiety and Depression Scale | Completed by carers | Baseline, 6 weeks, and 6 months |
| Change in score from baseline in Perceived Stress Scale | Completed by carers | Baseline, 6 weeks, and 6 months |
| Change in score from baseline in Multidimensional Scale of Perceived Social Support | Completed by carers | Baseline, 6 weeks, and 6 months |
| Change in score from baseline in Minnesota Living with Heart Failure Questionnaire | Completed by patients | Baseline, 6 weeks, and 6 months |
| Change in score from baseline in EuroQol Five Dimension Questionnaire | Completed by patients | Baseline, 6 weeks, and 6 months |
| Number of hospital admissions and GP visits with reasons over previous 6 months | For patients | Baseline and 6 months |
| Perspectives on how HELP has influenced behaviour | Data collected via bespoke questionnaires completed by carers and patients | Week 1, week 2, week 3, week 4, week 5, and week 6 |
| Perspectives on long-term adherence to support provided by HELP | Collected via a questionnaire completed by carers and patients | 6 months |
| Ulster Hospital | Not yet recruiting | Belfast | United Kingdom |
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| Craigavon Area Hospital | Not yet recruiting | Craigavon | United Kingdom |
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| Glasgow Royal Infirmary | Recruiting | Glasgow | United Kingdom |
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| King's College Hospital | Not yet recruiting | London | United Kingdom |
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