Implementation Testing of the Heart Failure Carer Support Programme in the United Kingdom.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Queen's University, Belfast
- Enrollment
- 360
- Locations
- 5
- Primary Endpoint
- Participant-reported experiences of fidelity of HELP implementation assessed by semi-structured interviews following a study-specific topic guide.
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
- •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
Arms & Interventions
Patients with symptomatic heart failure
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.
Carers
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).
Intervention: HEart faiLure carer support Programme (HELP) (Behavioral)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change in score from baseline in Zarit Burden Interview, Short Form(Baseline, 6 weeks, and 6 months)
- Change in score from baseline in Preparedness for Caregiving Scale(Baseline, 6 weeks, and 6 months)
- Change in score from baseline in 12-Item Short Form Survey(Baseline, 6 weeks, and 6 months)
- Change in score from baseline in Hospital Anxiety and Depression Scale(Baseline, 6 weeks, and 6 months)
- Change in score from baseline in Perceived Stress Scale(Baseline, 6 weeks, and 6 months)
- Change in score from baseline in Multidimensional Scale of Perceived Social Support(Baseline, 6 weeks, and 6 months)
- Change in score from baseline in Minnesota Living with Heart Failure Questionnaire(Baseline, 6 weeks, and 6 months)
- Change in score from baseline in EuroQol Five Dimension Questionnaire(Baseline, 6 weeks, and 6 months)
- Number of hospital admissions and GP visits with reasons over previous 6 months(Baseline and 6 months)
- Perspectives on how HELP has influenced behaviour(Week 1, week 2, week 3, week 4, week 5, and week 6)
- Perspectives on long-term adherence to support provided by HELP(6 months)
Investigators
Gareth Thomson
Project Manager
Queen's University, Belfast