TRICOLON is an investigator initiated, prospective, interventional, open-label, randomized, real-world, multi-centre, 3-arms study in the Netherlands. The primary objective is to investigate in COPD patients if single-inhaler triple therapy (SITT) is superior to multi-inhaler triple therapy (MITT) in terms of adherence to inhaled corticosteroids (ICS) therapy and to investigate if SITT with e-health support is superior to MITT and SITT without e-health support.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
300
Patients in the intervention group will receive the triple therapy in one inhaler in stead of multiple inhalers. The actual medication is the same.
Patients in intervention group 2 will receive Trimbow and will use the health app of Curavista and the smart-inhaler of FindAir
Patients in the intervention group will receive the triple therapy in multiple inhalers. The actual medication is the same.
Franciscus Gasthuis & Vlietland
Rotterdam, South Holland, Netherlands
RECRUITINGAdherence to ICS therapy
average adherence to ICS therapy (expressed as a percentage, measured as the number of actuations registered by the e-device divided by the total number of prescribed doses) over 12 months of treatment
Time frame: 12 months
TAI questionnaire score
questionnaire that identifies non-adherence and gives insight in the barriers related to the use of inhalers in asthma and COPD
Time frame: 12 months
CCQ questionnaire
measures health status and can be used to assess health-related quality of life
Time frame: 12 months
VAS score
a non-specific scale to score an outcome from 0 (not satisfied at all) to 10 (extremely satisfied)
Time frame: 12 months
PIH-NL
12-item scale to measure self-management behaviour and knowledge of patients with chronic diseases as COPD
Time frame: 12 months
WPAI
questionnaire to measure impairments in work and activities
Time frame: 12 months
EQ-5D-5L
questionnaire to assess the health-status
Time frame: 12 months
HLS-EU-Q16
assessment of patients' health literacy
Time frame: 12 months
Number exacerbations
A moderate exacerbation is defined as sustained worsening of the patient's condition, from a stable state and beyond day-to-day variation, that is acute in onset and warrants additional treatment (systemic corticosteroids and/or antibiotics). An exacerbation is defined as severe if hospitalization or emergency department visit is necessary
Time frame: 12 months
SABA use
Use of espace medication
Time frame: 12 months
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