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Table 1 SPIRIT schedule of enrollment, intervention, and assessments

From: Internet of things-based home noninvasive ventilation in COPD patients with hypercapnic chronic respiratory failure: study protocol for a randomized controlled trial

Timepoint

Study period

Enrolment

Allocation

Post-allocation

Close-out

Day 0

Day 1

3 months

6 months

12 months

12 months

Enrolment:

  Eligibility screen

X

     

  Informed consent

X

     

  Allocation

 

X

    

Interventions:

  NIPPV plus IOT

 

X

X

X

X

 

  NIPPV alone

 

X

X

X

X

 

ASSESSMENTS:

  Demographics

X

     

  Comorbidity

X

     

  Vital signs

 

X

X

X

X

 

  Hospital readmission

 

X

X

X

X

 

  Exacerbation

 

X

X

X

X

 

  Survival status

 

X

X

X

X

 

  Arterial blood gases

 

X

X

X

X

 

  Lung function

 

X

  

X

 

  SRI score

 

X

X

X

X

 

  CAT score

 

X

X

X

X

 

  mMRC score

 

X

X

X

X

 

  cNAT score

 

X

X

X

X

 

  Compliance

 

X

X

X

X

 

  Chest CT

 

X

  

X

 

  Electrocardiogram

 

X

  

X

 

  Echocardiography

 

X

  

X

 

  Routine laboratory tests

 

X

  

X

 

  Cost-effectiveness

 

X

X

X

X

 

  Safety

 

X

X

X

X

 
  1. NIPPV noninvasive positive pressure ventilation, IOT Internet of things, SRI severe respiratory insufficiency questionnaire, MRC Medical Research Council score, CAT COPD assessment test, cNAT COPD nocturnal symptom assessment test