Behavioural Intervention in Mechanically Ventilated Patients

Noninvasive Ventilation Clinical Trial

Official title:

Effects of a Behavioural Intervention in Home-based Mechanically Ventilated Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03932175
• Other study ID #: NIV - MyPathway
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: June 25, 2019

Study information

• Verified date: April 2019
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 67
• Est. completion date: June 25, 2019
• Est. primary completion date: June 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Disease Lung
• Noninvasive Ventilation

Intervention

Behavioral:
• Intervention group
Behaviorial intervention on non-invasive ventilation use and adherence alongside lifestyle changes recommendations supported by an mHealth tool (MyPathway app)

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

References & Publications (7)

Ambrosino N, Vitacca M, Dreher M, Isetta V, Montserrat JM, Tonia T, Turchetti G, Winck JC, Burgos F, Kampelmacher M, Vagheggini G; ERS Tele-Monitoring of Ventilator-Dependent Patients Task Force. Tele-monitoring of ventilator-dependent patients: a European Respiratory Society Statement. Eur Respir J. 2016 Sep;48(3):648-63. doi: 10.1183/13993003.01721-2015. Epub 2016 Jul 7. — View Citation

Bandura A. Self-efficacy mechanism in human agency. Am Psychol. 1982;37(2):122-47.

Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. — View Citation

Barberan-Garcia A, Ubré M, Roca J, Lacy AM, Burgos F, Risco R, Momblán D, Balust J, Blanco I, Martínez-Pallí G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293. — View Citation

de Lucas Ramos P, Rodríguez González-Moro JM, Paz González L, Santa-Cruz Siminiani A, Cubillo Marcos JM. [Current status of home mechanical ventilation in Spain: results of a national survey]. Arch Bronconeumol. 2000 Nov;36(10):545-50. Spanish. — View Citation

Lloyd-Owen SJ, Donaldson GC, Ambrosino N, Escarabill J, Farre R, Fauroux B, Robert D, Schoenhofer B, Simonds AK, Wedzicha JA. Patterns of home mechanical ventilation use in Europe: results from the Eurovent survey. Eur Respir J. 2005 Jun;25(6):1025-31. — View Citation

Troosters T, Maltais F, Leidy N, Lavoie KL, Sedeno M, Janssens W, Garcia-Aymerich J, Erzen D, De Sousa D, Korducki L, Hamilton A, Bourbeau J. Effect of Bronchodilation, Exercise Training, and Behavior Modification on Symptoms and Physical Activity in Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2018 Oct 15;198(8):1021-1032. doi: 10.1164/rccm.201706-1288OC. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self efficacy	Change in the Self Efficacy in Sleep apnea (SEMSA) questionnaire	3 months
Secondary	mHealth tool usability	mHealth tool usability assessed by the System Usability Scale	3 months
Secondary	Patient satisfaction	Patient satisfaction with the mHealth tool assessed by the Net Promoter Score	3 months
Secondary	Non-invasive ventilation adherence	Number of hours of daily use of the non-invasive ventilation machine during the study period	3 months
Secondary	Patient centred healthcare provision	Patient centred healthcare provision as measured by the Person Centred Coordinated Experience Questionnaire	3 months
Secondary	Continuity of care within the healthcare system	Continuity of care within the healthcare system as measured by the Nijmegen Continuity of Care Questionnaire	3 months
Secondary	Health and well-being	Change in quality of life assessed by the EuroQol-5D questionnaire	3 months
Secondary	Sleepiness	Change in sleepiness assessed by the Epworth Sleepiness Score	3 months

External Links

•   The ambition of the CONNECARE consortium is to co-design, develop, deploy, and evaluate a novel smart, adaptive integrated care system for chronic care management.