An interventional study of Intervention group in Noninvasive Ventilation and Chronic Disease Lung, sponsored by Hospital Clinic of Barcelona. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-30.
Sponsored by Hospital Clinic of Barcelona · Not applicable, Interventional, and Health services research
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.
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.
991 studies on the registry are indexed under Chronic Disease; 178 are open to participants now.
This study's enrollment of 67 is below the median of 120 across 722 interventional studies indexed under Chronic Disease.
Browse Chronic Disease studies →Hospital Clinic of Barcelona is the lead sponsor of 319 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: Intervention group
Patients will receive usual care according to guidelines on management of chronically ventilated patients, without any mHealth tool or behavioural intervention
Behaviorial intervention on non-invasive ventilation use and adherence alongside lifestyle changes recommendations supported by an mHealth tool (MyPathway app)
Self efficacy
Change in the Self Efficacy in Sleep apnea (SEMSA) questionnaire
Time frame: 3 months
mHealth tool usability
mHealth tool usability assessed by the System Usability Scale
Time frame: 3 months
Patient satisfaction
Patient satisfaction with the mHealth tool assessed by the Net Promoter Score
Time frame: 3 months
Non-invasive ventilation adherence
Number of hours of daily use of the non-invasive ventilation machine during the study period
Time frame: 3 months
Patient centred healthcare provision
Patient centred healthcare provision as measured by the Person Centred Coordinated Experience Questionnaire
Time frame: 3 months
Continuity of care within the healthcare system
Continuity of care within the healthcare system as measured by the Nijmegen Continuity of Care Questionnaire
Time frame: 3 months
Health and well-being
Change in quality of life assessed by the EuroQol-5D questionnaire
Time frame: 3 months
Sleepiness
Change in sleepiness assessed by the Epworth Sleepiness Score
Time frame: 3 months
Plan to share: No
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Hospital Clinic of Barcelona