Heart FailureHELPNCT07373041
Heart Failure Carer Support Programme: Implementation Testing in the UK.
A study testing HEart faiLure carer support Programme (HELP) in people with Heart Failure and Care Givers, run by Queen's University, Belfast at 5 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Care Givers, Self Management
- What is being tested?
- HEart faiLure carer support Programme (HELP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 29 May 2026to 29 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Aged 18 years or older
- Physical and mental ability to engage comfortably in conversation and be able to read written materials
Show all 9Show fewer
- 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)
Who cannot join
- Lacking capacity to give consent
- Under the age of 18
- Patients
- Lacking capacity to give consent
- Under the age of 18
- Carer refused to participate in HELP
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Donna Fitzsimons, PhD, RN contact
5 sites in 1 country
United Kingdom5 sites, 5 recruiting
- Not yet recruiting
Royal Victoria Hospital
Belfast
Lana Dixon, 028 9024 0503, lana.dixon@belfasttrust.hscni.net
- Not yet recruiting
Ulster Hospital
Belfast
Patrick Donnelly, 028 9048 4511, patrick.donnelly@setrust.hscni.net
- Not yet recruiting
Craigavon Area Hospital
Craigavon
Edith Donnelly, 028 3833 4444, Edith.Donnelly@southerntrust.hscni.net
- Recruiting
Glasgow Royal Infirmary
Glasgow
Yvonne Millerick, 0141 211 4000, yvonne.millerick@nhs.scot
- Not yet recruiting
King's College Hospital
London
Hannah Simmons, 020 3299 9000, hannah.simmons1@nhs.net
About this study
Official title: Implementation Testing of the Heart Failure Carer Support Programme in the United Kingdom.
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.
Read more
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.
- Conditions
- Heart Failure, Care Givers, Self Management
- Being tested
- HEart faiLure carer support Programme (HELP)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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. 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: HEart faiLure carer support Programme (HELP) |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline to 1 year
Secondary outcomes (11)
Change in score from baseline in Zarit Burden Interview, Short Form
Completed by carers.
Measured: Baseline, 6 weeks, and 6 months
Change in score from baseline in Preparedness for Caregiving Scale
Completed by carers
Measured: Baseline, 6 weeks, and 6 months
Change in score from baseline in 12-Item Short Form Survey
Completed by carers
Measured: Baseline, 6 weeks, and 6 months
Change in score from baseline in Hospital Anxiety and Depression Scale
Completed by carers
Measured: Baseline, 6 weeks, and 6 months
Change in score from baseline in Perceived Stress Scale
Completed by carers
Measured: Baseline, 6 weeks, and 6 months
Change in score from baseline in Multidimensional Scale of Perceived Social Support
Completed by carers
Measured: Baseline, 6 weeks, and 6 months
Change in score from baseline in Minnesota Living with Heart Failure Questionnaire
Completed by patients
Measured: Baseline, 6 weeks, and 6 months
Change in score from baseline in EuroQol Five Dimension Questionnaire
Completed by patients
Measured: Baseline, 6 weeks, and 6 months
Number of hospital admissions and GP visits with reasons over previous 6 months
For patients
Measured: Baseline and 6 months
Perspectives on how HELP has influenced behaviour
Data collected via bespoke questionnaires completed by carers and patients
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start29 May 2026
- Primary completion29 Nov 2027 (estimated)
- Study completion29 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- Belfast Health and Social Care Trust, Southern Health and Social Care Trust, South Eastern Health and Social Care Trust, King's College Hospital NHS Trust, Glasgow Royal Infirmary
- Responsible party
- Principal investigator, Gareth Thomson, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373041
- Sponsor's protocol ID
- B25/04
- Acronym
- HELP
- Status last verified
- May 2026
- First submitted
- 7 Jan 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 41996443
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation Testing of the Heart Failure Carer Support Programme in the United Kingdom.
- ClinicalTrials.gov ID
- NCT07373041
- Acronym / sponsor ID
- HELP / B25/04
- Conditions
- Heart Failure, Care Givers, Self Management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- Belfast Health and Social Care Trust, Southern Health and Social Care Trust, South Eastern Health and Social Care Trust, King's College Hospital NHS Trust, Glasgow Royal Infirmary
- Study start
- 29 May 2026 (actual)
- Primary completion
- 29 Nov 2027 (estimated)
- Study completion
- 29 Nov 2027 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carers | Experimental | Behavioral: HEart faiLure carer support Programme (HELP)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). |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- Aged 18 years or older
Key exclusion criteria (6 listed)
- Lacking capacity to give consent
- Under the age of 18
- Patients
- Lacking capacity to give consent
- Under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEart faiLure carer support Programme (HELP)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. | Behavioural | Carers |
Primary outcome
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.
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.
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.
11 secondary outcomes
Change in score from baseline in Zarit Burden Interview, Short Form
Time frame: Baseline, 6 weeks, and 6 months
Change in score from baseline in Preparedness for Caregiving Scale
Time frame: Baseline, 6 weeks, and 6 months
Change in score from baseline in 12-Item Short Form Survey
Time frame: Baseline, 6 weeks, and 6 months
Change in score from baseline in Hospital Anxiety and Depression Scale
Time frame: Baseline, 6 weeks, and 6 months
Change in score from baseline in Perceived Stress Scale
Time frame: Baseline, 6 weeks, and 6 months
Change in score from baseline in Multidimensional Scale of Perceived Social Support
Time frame: Baseline, 6 weeks, and 6 months
Change in score from baseline in Minnesota Living with Heart Failure Questionnaire
Time frame: Baseline, 6 weeks, and 6 months
Change in score from baseline in EuroQol Five Dimension Questionnaire
Time frame: Baseline, 6 weeks, and 6 months
Number of hospital admissions and GP visits with reasons over previous 6 months
Time frame: Baseline and 6 months
Perspectives on how HELP has influenced behaviour
Time frame: Week 1, week 2, week 3, week 4, week 5, and week 6
Perspectives on long-term adherence to support provided by HELP
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Derived from this study: PubMed 41996443Thompson 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Donna Fitzsimons, PhD, RN contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEart faiLure carer support Programme (HELP) in people with Heart Failure and Care Givers, run by Queen's University, Belfast at 5 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gareth Thompson, PhD (07714198795, gareth.thompson@qub.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant-reported experiences of fidelity of HELP implementation assessed by semi-structured interviews following a study-specific topic guide. (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07373041, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.