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Behavioural Intervention in Mechanically Ventilated Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03932175
Recruitment Status : Active, not recruiting
First Posted : April 30, 2019
Last Update Posted : April 30, 2019
Information provided by (Responsible Party):
CRISTINA EMBID LOPEZ, Hospital Clinic of Barcelona

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.

Condition or disease Intervention/treatment Phase
Noninvasive Ventilation Chronic Disease Lung Behavioral: Intervention group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two-groups, randomised parallel study with 1:1 ratio
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Health Services Research
Official Title: Effects of a Behavioural Intervention in Home-based Mechanically Ventilated Patients
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : June 19, 2019
Estimated Study Completion Date : June 25, 2019

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

No Intervention: Control group
Patients will receive usual care according to guidelines on management of chronically ventilated patients, without any mHealth tool or behavioural intervention

Primary Outcome Measures :
  1. Self efficacy [ Time Frame: 3 months ]
    Change in the Self Efficacy in Sleep apnea (SEMSA) questionnaire

Secondary Outcome Measures :
  1. mHealth tool usability [ Time Frame: 3 months ]
    mHealth tool usability assessed by the System Usability Scale

  2. Patient satisfaction [ Time Frame: 3 months ]
    Patient satisfaction with the mHealth tool assessed by the Net Promoter Score

  3. Non-invasive ventilation adherence [ Time Frame: 3 months ]
    Number of hours of daily use of the non-invasive ventilation machine during the study period

  4. Patient centred healthcare provision [ Time Frame: 3 months ]
    Patient centred healthcare provision as measured by the Person Centred Coordinated Experience Questionnaire

  5. Continuity of care within the healthcare system [ Time Frame: 3 months ]
    Continuity of care within the healthcare system as measured by the Nijmegen Continuity of Care Questionnaire

  6. Health and well-being [ Time Frame: 3 months ]
    Change in quality of life assessed by the EuroQol-5D questionnaire

  7. Sleepiness [ Time Frame: 3 months ]
    Change in sleepiness assessed by the Epworth Sleepiness Score

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03932175

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Hospital Clinic
Barcelona, Catalonia, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
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Principal Investigator: Cristina Embid, MD Hospital Clinic
Additional Information:
Bandura A. Self-efficacy mechanism in human agency. Am Psychol. 1982;37(2):122-47.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: CRISTINA EMBID LOPEZ, Doctor, Hospital Clinic of Barcelona Identifier: NCT03932175    
Other Study ID Numbers: NIV - MyPathway
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes