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临床试验/NCT05643924
NCT05643924已完成不适用

The Use of the COM-B Questionnaire to Determine the Psychological and Behavioural Barriers to Adherence in Patients with Asthma

Portsmouth Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2022年2月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
172
试验地点
1
主要终点
Can the COM-B questionnaire detect a patient's perceived psychological and behavioural barriers to adherence

研究概览

简要总结

Asthma is a common lung condition that cannot be cured, although usually it can be effectively controlled with available treatments. Yet, it is well recognised that 70% of patients are non-adherent to their asthma treatment.

Personalising treatment by offering the most relevant interventions based on the patient's psychological/behavioural needs results in great success. However, health care providers have limited available resources to deliver a patient-centred approach to their psychological/behavioural needs, resulting in a current one-size-fits-all strategy due to the non-feasible nature of existing surveys.

The solution would be to provide health care professionals with a clinically feasible questionnaire that identifies the patients personal psychological/behavioural factors to adherence.

详细描述

Asthma is a common lung condition affecting over 5.4 million people in the UK, for some people, it can affect daily activities and lead to life-threatening consequences. (Asthma UK 2020). Asthma cannot be cured, but it can usually be effectively controlled with available treatments provided they are taken as recommended; however, it is well recognised that up to 70% of patients do not take their asthma treatments as recommended (are non-adherent). This is perhaps not unexpected in the context of a chronic condition requiring daily treatments, which must be taken even when the person feels well. People may also have concerns about using long-term medicines (including steroid inhalers,) or there may be other psychological/behavioural barriers to adherence. Non-adherence to asthma treatments results in poor asthma control with persisting asthma symptoms, more frequent asthma attacks and greater impairment in quality of life. There are also significant economic implications associated with 'wasted' medications and additional healthcare utilisation, such as doctors' appointments and visits to A&E, which contribute to the overall cost of asthma care in the UK, exceeding £1 billion per year.

Health care professionals play an important role in engaging and educating patients about the importance of their asthma treatments, monitoring asthma control and identifying whether a patient is adherent or not. Adherence is complex involving (1) being able to start prescribed medications; (2) taking the medications as prescribed (correct dose, inhalation technique, and frequency); and (3) persistence (obtaining refills to maintain adherence over time). There are limited resources available in a busy health care setting to ensure a complete understanding of each individual's psychological/behavioural barriers, with a one-size-fits-all approach adopted with limited success. As such, there is a persistent unmet need for a tool that can effectively identify these barriers to adherence in a clinical setting, allowing health care professionals to provide effective personalised treatments for non-adherence in patients with asthma.

It is important that the psychological needs of patients can be easily assessed to allow for the patients' personal needs to be understood, promoted, improved, and supported (Lyons & Chamberlain, 2006). When focusing on adherence behaviour, currently, the tools available are questionnaires, but these are long and complex to complete. The COM-B model is a new questionnaire that is shorter and easier for patients to complete. It involves three key components: Capability, Opportunity, and Motivation (Michie et al., 2017). These components were grouped from current health psychological theories of behaviour and behaviour change, therefore, providing a theoretical lens through which to view the physical capability, psychological capability, physical opportunity, social opportunity, reflective motivation, and automatic motivation of individuals. The information gathered from the COM-B framework can then be used to identify what needs to change for a behavioural change intervention to be successful (Michie, Van Stralen & West, 2011).

An easily accessible theory-based tool (a questionnaire) that can identify the psychological and behavioural barriers of patients with asthma who are non-adherent with their treatment is urgently required. This will allow healthcare professionals to use effective personalised interventions to support improved medication use whilst recognising and meeting the psychological needs of patients with asthma. Additionally, the Covid pandemic has changed the way people with asthma access their care with a move to remote consultations and questionnaire completion. The COM-B questionnaire may well be suitable for this approach. Still, it is essential to assess digital readiness in this population to understand whether this is feasible and inform the design of future studies if the COM-B questionnaire proves to be successful.

Primary Objective:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 years or over
  • Willing and able to give informed consent for participation in the study.
  • Diagnosis of asthma confirmed by a healthcare professional and requiring maintenance asthma treatment, including an inhaled corticosteroid

排除标准

  • Unable to comprehend the study and provide informed consent, e.g., insufficient command of English in the absence of someone who can adequately interpret.

结局指标

主要结局

Can the COM-B questionnaire detect a patient's perceived psychological and behavioural barriers to adherence

时间窗: 3 Years

Comparisons of the (1) short COM-B questionnaire (2) 61-item Theoretical Domain Framework Questionnaire to assess content validity. A low score on the COM-B questionnaire and the Theoretical Domains Framework Questionnaire indicates that the individual is experiencing a barrier based on that source of behaviour domain.

次要结局

  • Can the COM-B questionnaire be used in a clinical asthma pathway?(3 Years)
  • To explore the key psychological and behavioural barriers indicated by the COM-B questionnaire and adherence to treatment in patients with confirmed asthma with heterogenous severity(3 Years)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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