2.2.1 Setting.

This study will be conducted across five hospital sites spanning three regions of the UK (Northern Ireland, England, and Scotland). Local HF nurses will deliver HELP to carers of patients with HF within their corresponding region. The collaborating sites will constitute early adopters of HELP and will be designated as ‘Beacon Sites’. These Beacon Sites will be used to model programme implementation, which is a method of informing and supporting embedding of innovative practice [16]. The collaborating sites were selected due to their ability to commit to HELP implementation, to diversify sample inclusion, and increase geographic spread.

2.2.2 Sample and recruitment.

This study will recruit participants across three populations: 1. Carers, 2. Patients with HF, and 3. Healthcare Professionals. In compliance with the Screened, Eligible, Approached, Randomised/ Recruited (SEAR) framework [17], anonymised screening and recruitment logs will be used to document numbers and percentages of eligible and recruited participants, along with reasons for non-participation and withdrawal. These data will be monitored by the Steering Group to identify recruitment barriers and inform necessary strategies to optimise enrolment across the collaborating sites.

2.2.4 Carers.

The target population of HELP is informal carers of patients with symptomatic HF. These individuals will be eligible to participate if they are: 1) Aged 18 years or older; 2) Physically and mentally capable of operating a digital device; 3) Able to engage comfortably in conversation with peers and capable of reading written materials; 4) Caring (regular, unpaid care) for a person with a clinical diagnosis of HF who is receiving standard evidence-based HF therapies and has either HF symptoms or one episode of decompensation (symptoms requiring medical attention) in previous six months; and 5) Capable of speaking and understanding English.

There will be five programme rollouts of HELP (six weeks each) across each of the three collaborating nations over a one-year period, with twelve carers per rollout (60 carers per nation; 180 carers in total). This sample size was pragmatically determined by the maximum study duration within the funding limit, along with the recruitment rate demonstrated in the pilot study [10].

2.2.5 Patients.

Patients who are receiving informal support from the recruited carers will be invited to participate via the provision of data, which will allow their perspectives on HELP implementation to be captured, whilst also facilitating an assessment of the potential, dyadic impact of the intervention. These patients will be eligible to participate if they are: 1) Aged 18 years or older; 2) Physically and mentally able to engage comfortably in conversation and capable of reading written materials; 3) Clinically diagnosed with HF and receiving standard evidence-based HF therapies and either have HF symptoms or one episode of decompensation (symptoms requiring medical attention) in previous six months; 4) Able to speak and understand English; and 5) Receiving regular, unpaid support with managing their condition from a loved one (i.e., a relative or spouse) or friend. Patients will be ineligible if their carers refused to participate in HELP. Carers will remain eligible for participation regardless of patient enrolment. One patient per carer will be invited to participate to enhance sample diversity (approximately 180 patients in total).

2.2.6 Carer and patient recruitment.

Local cardiology teams will identify and approach potential participants during routine, in and out-patient HF appointments. Eligible patients will receive information packs for both them and their carer. Those interested in participation will provide permission to be contacted by the research team for recruitment. During this contact, patients will also signpost the research team to their interested carers. Subsequently, these carers will be contacted by the research team for eligibility screening and recruitment. The collaborating hospital sites cover regions with a range of socio-demographic characteristics (i.e., education level, socio-economic status, and ethnicity), which will maximise the diversity of the recruited sample.

2.2.7 Healthcare professionals.

Healthcare professionals (i.e., HELP delivery staff, cardiologists, and HF nurses) across the collaborating sites will be invited to provide process evaluation data. These individuals will be supplied with information sheets and will be asked to contact the research team if interested in participation. Healthcare professionals will be eligible if they are 1) Members of the cardiology team, 2) Aged 18 years or older, and 3) Willing to provide informed consent.

2.2.8 Intervention design.

HELP design was based on prior literature and comprehensive input from carers of patients with HF and healthcare professionals, with the co-development and feasibility testing of this intervention previously reported in detail [10]. HELP constitutes a six-week, nurse-led, psychoeducational programme comprising two components:

1. 1). Online support group sessions

Nurse-led, weekly online support group sessions are delivered to groups of approximately twelve carers over a six-week period. Each session lasts sixty minutes and is underpinned by a standardised, educational presentation covering the topics displayed in Table 1. Following each educational presentation, the HF nurse facilitates a group discussion to issue tailored advice, guidance, and signposting, along with providing a platform for carers to engage in peer support.

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Table 1. Support Group Schedule.

https://doi.org/10.1371/journal.pone.0347037.t001

1. 2). Self-directed, educational resources (booklet and website)

Upon HELP enrolment, carers will receive an educational booklet (S3 Text) and access to a supplementary website. Both resources were co-designed and professionally produced. The educational booklet complements the online support group sessions by facilitating self-directed learning across the following five chapters:

1. Chapter 1: What is HF?
2. Chapter 2: Planning for the future
3. Chapter 3: Looking after yourself
4. Chapter 4: Communication
5. Chapter 5: Your role as a carer

Each chapter is completed over the week leading to the corresponding online support group session. The self-directed website supplements the booklet by presenting the same educational information in a potentially more engaging format (i.e., animations, interactive content, and topic summaries). Additionally, the website provides access to the standardised educational presentations for the online support group sessions, along with facilitating the submission of non-urgent questions for the HF nurse to answer at the subsequent online support group session.

HELP is underpinned by the Transactional Theory of Stress and Coping [18], which postulates that adaptive coping strategies can moderate the relationship between the perception of potentially stressful experiences and negative outcomes (i.e., burnout and distress). By facilitating improved access to information and support from peers and healthcare professionals, the intervention will deliver key practical and emotional coping resources to alleviate stress, burden, and improve carer wellbeing, ultimately empowering carers in their caregiving role. The intervention components are mapped to the Theoretical Domains Framework, which facilitates further theoretical grounding of the mechanisms of impact for behavior change [19]. Consistent with MRC guidance for complex interventions [20], Fig 2 presents a preliminary logic model illustrating the key aspects of HELP, which will evolve according to the results of this study.

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Fig 2. HELP Logic Model.

Legend HF = Heart Failure; QoL = Quality of Life; UK = United Kingdom; HELP = HEart faiLure carer support Programme; HSC = Health and Social Care; NHS = National Health Service; and in parentheses () and italics = mapping to Theoretical Domains Framework.

https://doi.org/10.1371/journal.pone.0347037.g002

2.2.9 Intervention delivery.

HELP will be delivered by local specialist HF nurses across the collaborating sites. Following recruitment, carers will be assigned a start date for HELP. One week prior to the first online support group session, carers will receive the educational booklet and access to the supplementary website, along with supporting programme materials (i.e., online support group schedule and guidance on joining online sessions). Carers will be advised to read each chapter of the educational booklet and supplementary website before the corresponding online support group session. The online support group sessions will run on ‘Zoom’, with a link and password to each session issued to carers before commencement. Carers will receive a reminder email two days before each online support group session. The research team will remain in contact with all participants to provide ongoing support with accessing the online support group sessions and supplementary website.

The nurse-led, online support group sessions will be delivered using an informal approach to facilitate a comfortable environment for the carers. Each session will consist of twelve carers and last approximately sixty minutes. The sessions will initiate with a standardised, educational presentation (approximately 20 minutes) on the allocated topic, with the remainder of the session (approximately 40 minutes) dedicated to questions raised during the session or submitted via the website; group discussion; tailored advice and signposting; and peer support. Carers will receive the option of having their cameras switched on or off during the sessions and will be encouraged to use the chat function to ask questions if unwilling to speak in front of the group.

Five programme rollouts of HELP (six weeks each) will be delivered across each of the three collaborating nations over a year period, with twelve carers per rollout (60 carers per nation; 180 carers in total). Rollouts will be separated by four-week windows, which will account for staff holidays and provide recruitment intervals for the subsequent rollout.

2.2.10 Implementation strategy.

The development of implementation strategies is an evidence-based method of promoting uptake of a novel intervention by healthcare professionals [21]. Accordingly, guided by the NPT framework [14], we engaged with healthcare professionals (approximately forty HF nurses and cardiologists) across our five collaborating sites in the UK to co-develop a multi-faceted implementation strategy for HELP, which is theoretically grounded across: 1) Coherence (i.e., does the intervention make sense?), 2) Cognitive participation (how do people engage?), 3) Collective action (how do people work with the intervention?), and 4) Reflexive monitoring (how do people appraise the intervention?). This iterative, developmental process spanned three, one-hour stakeholder meetings, resulting in the identification of four principal implementation agents (1. HELP Delivery Staff, 2. Referral staff, 3. Clinical Leadership, and 4. Carers). A multi-faceted implementation strategy was developed based on clinical and academic input, which employs tailored methods of supporting HELP implementation for each of the implementation agents (S4 Table).

Depending on preference, intervention delivery staff will receive online or in-person training from the project team, which will employ an interactive approach including content talks, case scenario discussions, and role plays. This training programme will familiarise delivery staff with intervention design and cover essential skills for implementation (i.e., effective communication, building trusting relationships, managing conflict, and delivering behaviour change techniques). These staff will also receive access to standardised intervention materials and support documents (i.e., intervention protocol and fidelity checklist), with regular support and monitoring by the project team at and between Steering Group meetings. As detailed in S4 Table, the other key implementation agents (i.e., HELP referral staff, clinical leadership, and carers) will be supported via communication with the research team, information from project documents (i.e., screening log and information sheets), and monitoring at Steering Group meetings.

2.3.1. Demographic characteristics.

Participants will be asked to complete a demographic questionnaire at baseline (i.e., age, gender, ethnicity, education level, employment status, and duration of care provision). These data will be used to contextualise the samples and findings.

2.3.2 Process evaluation.

The multi-faceted implementation strategy will be assessed via a process evaluation of acceptability, fidelity, and context of HELP delivery across the collaborating clinical sites. Consistent with the framework published by the National Institutes of Health Behaviour Change Consortium [22], the fidelity examination will include the following:

1. Study design: Protocol and intervention deviations will be documented and reported in implementation and HELP delivery staff logs.
2. Provider training: Following training, intervention competency of HELP delivery staff will be assessed during a ‘role play’ session with a fidelity checklist.
3. Intervention delivery: Online support group session recordings will be evaluated using an intervention fidelity checklist spanning: 1) Interactional style (i.e., carer-centred approach); 2) Intervention components covered and those omitted; 3) Components added; 4) Dosage (i.e., session duration and attendance); and 5) Competency (i.e., maintenance of skill set).
4. Treatment receipt and enactment: Carers’ understanding of the information provided and ability to implement the skills and recommendations delivered by HELP will be investigated via bespoke, weekly HELP impact (completed intra-intervention) and long-term adherence questionnaires (completed six months post-intervention), along with deeper exploration via interviews (discussed below).

Contextual factors will be assessed via data (i.e., ‘background noise’ and protocol deviations) recorded in the implementation and HELP delivery staff logs, along with an evaluation of bespoke, intervention acceptability questionnaires completed by carers and HELP delivery staff. Individual, semi-structured interviews (approximately 60 minutes in duration) will also be conducted via telephone calls with participants at 6 months or study end (eighteen months), which will add rich, qualitative data to the assessment of acceptability, fidelity, and context. A “laddered-style approach” will be implemented in the interviews to explore emerging ideas [23], with the topic guides (S5 Text) based on the domains of CFIR and NPT [13,14]. Approximately thirty-three interviews will be conducted with carers (number (n) = 10), patients (n = 10), HELP delivery staff (n = 3), and healthcare professionals (n = 10 in total, i.e., n = 5 HF nurses and n = 5 cardiologists). This sample size is based on recommendations for a study of this scope [24]. A purposive sampling strategy [25] will maximise representation and diversity across the samples (i.e., age, gender, ethnicity, education, and socio-economic status), with equal numbers of cases recruited across the collaborating sites. All interviews will be audio-recorded before verbatim transcription.

2.3.3 Economic evaluation.

The economic cost of intervention implementation in the UK will be estimated via the collection of the following data from implementation and HELP delivery staff logs:

1. 1). Training costs and time input for supervision of HELP delivery staff.
2. 2). The time, expenditure, resources required, and adaptations made for HELP implementation by delivery staff.

2.3.4 Participant outcomes.

The short and long-term impact of HELP on outcomes for carers and patients will be assessed across data from validated questionnaires, patient diaries, and medical records (see Table 2). Participant outcome data will be collected at three time points: 1. Baseline, 2. Post-intervention (week six), and 3. Six months post-intervention.

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Table 2. Participant Outcomes and Measurement Instruments.

https://doi.org/10.1371/journal.pone.0347037.t002

2.5.1 Quantitative data.

Quantitative data analysis will be managed on Statistical Package for the Social Sciences (IBM SPSS Statistics, Version 31). Continuous data will be presented as mean ± standard deviation, with discrete data reported as absolute numbers and percentages. Categorical data will be displayed as frequency/ percentages. For participant outcomes, repeated measures analysis of variance will be used to investigate the effect of time point on outcome scores. Due to the absence of statistical power, the results will be used to identify preliminary evidence of promise for the intervention across different participant outcomes, with potential effect sizes generated to inform the required sample size for a future definitive evaluation.

2.5.2 Qualitative data.

Qualitative data will be managed on NVivo (QSR International Pty Ltd. Version 15). Transcripts will be analysed using adaptive framework analysis [34] based on the CFIR and NPT domains [13,14], whilst allowing the integration of data that could not be placed in pre-specified categories. An a priori codebook will be established to guide the analysis. Definitions of CFIR and NPT domains will be tailored to the project, which will improve coder consistency. A member of the central research team will undergo data familiarisation before mapping major themes to the CFIR and NPT domains. Anonymised quotes from participants will be used to support the generation of themes. Differences between and within regions will be compared. A second member of the central research team will independently analyse and verify a random selection of transcripts. Subsequently, the results will be reviewed by the wider project team, with discrepancies discussed until consensus agreement.

2.5.3 Data integration.

Data integration will be conducted according to the recommendations of Farmer et al. [35]. Guided by CFIR and NPT domains [13,14], this integrative analysis will involve the development of a convergent coding matrix to identify synergies (key findings) across the analytic components (i.e., acceptability, fidelity, context, and participant outcomes). Two members of the central research team will integrate quantitative and qualitative data separately, with discrepancies discussed and reviewed by the wider project team until consensus agreement.

2.5.4 Economic analysis.

HELP delivery costs will be estimated according to resource utilisation data collected during the project and unit costs for resource use obtained from published national or National Health Service sources [36]. Resource use will consist of time input from HELP facilitators, supervision for facilitators, training costs for facilitators, and consumables/ adaptations required for HELP delivery. Delivery costs will be estimated at session and programme-level and reported in pounds sterling (£).