Effects of a Behavioural Intervention in Home-based Mechanically Ventilated Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Self efficacy
研究概览
简要总结
Background: Non-invasive ventilation at home for chronic respiratory failure due to different etiologies has proven effective regarding mortality and quality of life. Nonetheless, adherence to therapy still constitutes a clinical day-to-day problem. Physiological monitoring has shown to improve adherence. We hypothesise that an additional behavioural intervention delivered via mHealth tools, on top of usual care, can further enhance therapeutical success alongside patient satisfaction.
Methods: Randomized single-blinded controlled trial with an intervention and control groups. Intervention will consist of a multi-component based behavioural intervention delivered via a mHealth tool, during a three-month period. Primary objective will be change in self-efficacy towards non-invasive ventilation use
Statistical Analysis: Based on a change of 0.5 units in the Self Efficacy in Sleep apnea (SEMSA) questionnaire, a sample size of 30 subjects per study arm was calculated. It has been anticipated a drop-out rate of 5%. Standard statistical analysis will take place.
Expected results: we expect a positive change on the SEMSA score (reflecting better self-efficacy) after three-month use. Indirectly, this enhancement should facilitate patient adherence specifically via mask leak problems resolution. Also, we presume that the proposed mHealth tool will be highly usable and accepted by the patients, leading to overall satisfaction with the service provided.
详细描述
The polio epidemics demonstrated the safety and efficacy of non-invasive ventilation (NIV) to decrease mortality. Since then, this therapeutic approach has been shown to reduce hospital admissions, impact favourably on health-related quality of life (HRQL), improve sleep quality and reduce mortality in patients with diverse chronic pathologies. This success has driven the increase in prevalence of patients using home NIV in Europe, ranging from 4.5 to 20 per 100,000 adults.
The use of NIV at home has been proven to be cost-effective, but patients' adherence to therapy has still potential to improve which should further enhance healthcare efficiencies of the intervention. Optimization of physiological settings and monitoring can contribute to enhance adherence by improving timely detection of problems such as mask leaks, patient-ventilator asynchronies, etc. However, improvement of behavioural aspects such as patient motivation and empowerment for self-management are also important factors to consider when addressing adherence to respiratory therapies.
The current protocol seeks to explore the transfer of previous positive experiences on behavioural interventions in other fields (i.e. physical activity into home-based NIV and, in general, into respiratory therapies. Specifically, we will explore the concept of self-efficacy. It is defined as the individual's perceived capability to perform the particular behaviour. A person who does not believe in her or his own capability to perform a desired action will fail to adopt, initiate, and maintain it. Self-efficacy is therefore seen as the most influential motivational factor and the strongest predictor of behavioural intentions.
The application of self-efficacy to the problem of identifying predictors of BIPAP use derives from the social cognitive theory concept of Bandura (Bandura's model). This model has been widely applied in studies of the adoption, initiation, and maintenance of health-promoting behaviors and consists of the concepts of perception of the risk to health, expectations regarding treatment outcome (outcome expectancies), and the confidence or volition to engage in the behavior (treatment self-efficacy).
Alongside this well-defined behavioural concept, we also identify the role of information and communication technologies (ICT) as a promising scenario to generate efficiencies by enhancing coordination between stakeholders and contributing to improve health outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor will assess only anonymized data from the two study groups, wherein every group will also be de-identified in relation to its study arm.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients with hypercapnic ventilatory failure due to chest wall, neuromuscular, lung parenchyma and/ or airway disease already receiving treatment with non-invasive ventilation irrespective of treatment duration.
- •Having a mobile phone, tablet or personal computer that can support the use of MyPathway application.
- •Accepting to participate in the study and signing informed consent.
排除标准
- •Clinical instability (including a respiratory acute exacerbation) at time of assessment for study enrolment.
- •Not willing to use the proposed mHealth tool at home.
- •Severe psychiatric disease.
研究组 & 干预措施
Intervention group
The multicomponent intervention will comprise three aspects on-top of usual care: i) Motivational interview to assess patient's adherence profile and to raise the compromise with the behaviour change towards NIV, physical activity and nutritional habits; ii) Bi-directional interaction between the study participants and clinical staff delivered by the MyPathway app, where specific clinical problems regarding NIV will be addressed as they arise; and iii) Motivational messages and educational material delivered via the MyPathway app regarding changes in physical activity and/or nutritional habits. As part of the behavioural intervention, goal setting for NIV adherence and life-style changes will be introduced to the MyPathway app in order for the participants to follow the advice.
干预措施: Intervention group (Behavioral)
Control group
Patients will receive usual care according to guidelines on management of chronically ventilated patients, without any mHealth tool or behavioural intervention
结局指标
主要结局
Self efficacy
时间窗: 3 months
Change in the Self Efficacy in Sleep apnea (SEMSA) questionnaire
次要结局
- Patient satisfaction(3 months)
- Patient centred healthcare provision(3 months)
- Health and well-being(3 months)
- Sleepiness(3 months)
- mHealth tool usability(3 months)
- Non-invasive ventilation adherence(3 months)
- Continuity of care within the healthcare system(3 months)
研究者
CRISTINA EMBID LOPEZ
Doctor
Hospital Clinic of Barcelona