Heart Failure Carer Support Programme: Implementation Testing in the UK.

Официальное название

Implementation Testing of the Heart Failure Carer Support Programme in the United Kingdom.

Обзор

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.

Вмешательства

• Поведенческое 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 discussi

Первичные конечные точки

• Participant-reported experiences of fidelity of HELP implementation assessed by semi-structured interviews following a study-specific topic guide. [Срок оценки: 6 months]
• Participant-reported experiences of contextual factors influencing HELP implementation assessed by semi-structured interviews following a study-specific topic guide. [Срок оценки: 6 months]
• Cost of HELP implementation. [Срок оценки: Baseline to 1 year]

Вторичные конечные точки (11)

• Change in score from baseline in Zarit Burden Interview, Short Form [Срок оценки: Baseline, 6 weeks, and 6 months]
• Change in score from baseline in Preparedness for Caregiving Scale [Срок оценки: Baseline, 6 weeks, and 6 months]
• Change in score from baseline in 12-Item Short Form Survey [Срок оценки: Baseline, 6 weeks, and 6 months]
• Change in score from baseline in Hospital Anxiety and Depression Scale [Срок оценки: Baseline, 6 weeks, and 6 months]
• Change in score from baseline in Perceived Stress Scale [Срок оценки: Baseline, 6 weeks, and 6 months]
• Change in score from baseline in Multidimensional Scale of Perceived Social Support [Срок оценки: Baseline, 6 weeks, and 6 months]
• Change in score from baseline in Minnesota Living with Heart Failure Questionnaire [Срок оценки: Baseline, 6 weeks, and 6 months]
• Change in score from baseline in EuroQol Five Dimension Questionnaire [Срок оценки: Baseline, 6 weeks, and 6 months]
• Number of hospital admissions and GP visits with reasons over previous 6 months [Срок оценки: Baseline and 6 months]
• Perspectives on how HELP has influenced behaviour [Срок оценки: Week 1, week 2, week 3, week 4, week 5, and week 6]
• Perspectives on long-term adherence to support provided by HELP [Срок оценки: 6 months]

Критерии участия

Carers

Критерии включения

• 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

Критерии исключения

• Lacking capacity to give consent
• Under the age of 18

Patients

Критерии включения

• 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)

Критерии исключения

• Lacking capacity to give consent
• Under the age of 18
• Carer refused to participate in HELP

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Великобритания · 5 центров

• Royal Victoria Hospital — Belfast
• Ulster Hospital — Belfast
• Craigavon Area Hospital — Craigavon
• Glasgow Royal Infirmary — Glasgow
• King's College Hospital — London

Публикации

• 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/journ PMID 41996443

Идентификаторы

NCT: NCT07373041 · B25/04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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