Heart Failure Carer Support Programme: Implementation Testing in the UK.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorQueen's University, Belfast
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Lacking capacity to give consent
Under the age of 18
Aged 18 years or older
Physical and mental ability to engage comfortably in conversation and be able to read written materials
Trial design
Design model
Single group
Treatments tested in this trial
HEart faiLure carer support Programme (HELP)
BehavioralA 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.
Treatment groups
360 Participants
are divided into 2 treatment groupsGroup A: CarersExperimental treatment 1 intervention
Group B: Patients with symptomatic heart failureNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
6 months2
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.
Time frame
6 months3
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.
Time frame
Baseline to 1 yearSecondary outcomes
1
Change in score from baseline in Zarit Burden Interview, Short Form
Completed by carers.
Time frame
Baseline, 6 weeks, and 6 months2
Change in score from baseline in Preparedness for Caregiving Scale
Completed by carers
Time frame
Baseline, 6 weeks, and 6 months3
Change in score from baseline in 12-Item Short Form Survey
Completed by carers
Time frame
Baseline, 6 weeks, and 6 months4
Change in score from baseline in Hospital Anxiety and Depression Scale
Completed by carers
Time frame
Baseline, 6 weeks, and 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Queen's University, Belfast
Lead sponsor
Belfast Health and Social Care Trust
Collaborator
Southern Health and Social Care Trust
Collaborator
South Eastern Health and Social Care Trust
Collaborator
King's College Hospital NHS Trust
Collaborator
Glasgow Royal Infirmary
Collaborator
Source ClinicalTrials.gov