Clinical trial NCT03932175: Behavioural Intervention in Mechanically Ventilated Patients
Official title: Effects of a Behavioural Intervention in Home-based Mechanically Ventilated Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Noninvasive Ventilation
Chronic Disease Lung
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2019-04-30
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-groups, randomised parallel study with 1:1 ratio
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Nonetheless, it is acknowledged that the scenario is not still mature. Mainly, because of lacking evidence in real-world scenarios for the capacity of ICT to escort behavioural changes in chronic complex patients. It is widely accepted that, despite current limitations, chronic complex patients are an ideal population where care coordination, patient and medical staff satisfaction alongside patient empowerment are of utmost importance to produce health benefits.

The study protocol intends to produce evidence on the capacity of a behavioural intervention to increase patient empowerment for self-management and adherence to therapy accompanied by an ICT tool interoperable with the information system of the healthcare provider. Moreover, the intervention should generate high acceptability/satisfaction among patients, carers and professionals. We fully acknowledge that if the expected results are achieved, the proposed study shall be followed by long-term assessment of the impact of the intervention.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Self efficacy
timeFrame: 3 months
Secondary outcomes:
measure: mHealth tool usability
timeFrame: 3 months
measure: Patient satisfaction
timeFrame: 3 months
measure: Non-invasive ventilation adherence
timeFrame: 3 months
measure: Patient centred healthcare provision
timeFrame: 3 months
measure: Continuity of care within the healthcare system
timeFrame: 3 months
measure: Health and well-being
timeFrame: 3 months
measure: Sleepiness
timeFrame: 3 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
state: Catalonia
Study officials:
affiliation: Hospital Clinic
name: Cristina Embid, MD
role: PRINCIPAL_INVESTIGATOR
References:
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