Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Inhaler Technique Education in Elderly Patients With Asthma or COPD: Impact on Disease Exacerbations - a Protocol for a Single-blinded Randomised Controlled Trial
Brief Summary: Introduction COPD and Asthma affect more than 10% of the population. Most patients use their inhaler incorrectly, mainly the elderly, thereby becoming more susceptible to poor clinical control and exacerbations. Placebo device training is regarded as one of the best teaching methods, but there is scarce evidence to support it as the most effective one to improve major clinical outcomes. Our objective is to perform a single-blinded RCT to assess the impact of this education tool in these patients.

Methods and Analysis A multicentre single-blinded RCT will be set, comparing a placebo-device training programme versus usual care, with a one-year follow-up, in elderly patients with Asthma or COPD. Intervention will be provided at baseline, and after 3 and 6 months, with interim analysis at an intermediate time point. Exacerbation rates were set as primary outcomes, and quality of life, adherence rates, clinical control and respiratory function were chosen as secondary outcomes. A sample size of 146 participants (73 in each arm) was estimated as adequate to detect a 50% reduction in event rates. Two-sample proportions Chi-squared test will be used to study primary outcome and subgroup analysis will be carried out according to major baseline characteristics.

Discussion The investigators expect to confirm that inhaler performance education will significantly reduce exacerbation rate and improve clinical and functional control.

Ethics and dissemination:

Every participant will sign a consent form. A Data Safety Monitoring Board will be set up to evaluate data throughout the study and to monitor stop earlier criteria. Identity of all participants will be protected. Results will be presented in scientific meeting and published in peer-reviewed journals.


Options:
A: Arm Label: Inhaler technique education; Type: EXPERIMENTAL; Interventions: Behavioral: Inhaler technique education | Arm Label: Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Inhaler technique education; Assigned to Arm(s): Inhaler technique education
B: Arm Label: Activity Monitoring - Smartphone; Type: N/A; Interventions: N/A | Arm Label: Activity Monitoring - Wearable; Type: N/A; Interventions: N/A
C: Arm Label: Roflumilast escalation dosage; Type: EXPERIMENTAL; Interventions: Drug: Roflumilast escalation dosage | Arm Label: Roflumilast conventional dosage; Type: EXPERIMENTAL; Interventions: Drug: Roflumilast conventional dosage | Intervention Type: DRUG; Name: Roflumilast escalation dosage; Assigned to Arm(s): Roflumilast escalation dosage | Intervention Type: DRUG; Name: Roflumilast conventional dosage; Assigned to Arm(s): Roflumilast conventional dosage
D: Arm Label: Health Coaching; Type: EXPERIMENTAL; Interventions: Behavioral: Health Coaching | Arm Label: Usual care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Health Coaching; Assigned to Arm(s): Health Coaching

Answer: A