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Behavioural Intervention in Mechanically Ventilated Patients

NCT03932175 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2019-04-30

No results posted yet for this study

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.

Conditions

  • Noninvasive Ventilation
  • Chronic Disease Lung

Interventions

BEHAVIORAL

Intervention group

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

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    lead OTHER

Principal Investigators

  • Cristina Embid, MD · Hospital Clinic

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2019-06-19
Completion
2019-06-25

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03932175 on ClinicalTrials.gov