Management to Improve Control of Asthma study

A cluster randomised trial with a factorial design to test the effectiveness of two brief asthma management interventions for improving asthma control and reducing morbidity in primary care, compared with usual care alone

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000854033

Acronym

MICA

Enrollment

220

Registered

2010-10-14

Start date

2010-10-11

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The main goal of asthma treatment is to achieve good asthma control. This cluster randomised trial will test the effectiveness of two brief asthma management interventions, delivered by GPs, for improving asthma control in primary care. The effect of both interventions separately and their interaction will be tested by multiple linear regression.

Interventions

Inhaled Salmeterol/fluticasone (all groups); This study will compare four brief asthma management strategies for delivery by general practitioners (GPs) during normal consultations.

Study design

Allocation

Randomised controlled trial

Intervention model

Factorial

Primary purpose

Educational / counselling / training

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

14 Years to 65 Years

Healthy volunteers

Inclusion criteria

GPs (a) Access to a computer and email during consultations Patients (a) Age 14-65 yrs (b) Current prescription for inhaled corticosteroid/long-acting beta2 agonist (ICS/LABA) (the most common preventer treatment in Australia) (c) Asthma not well-controlled (Asthma Score <=19)

Exclusion criteria

GPs: Access to a computer and email in the practice. Patients: Exclusion criteria: (a) asthma exacerbation (oral corticosteroids (OCS), emergency department (ED) visit or hospitalisation) in the last month (b) other major respiratory disease e.g. Chronic Obstructive Pulmonary Disease (COPD), or serious uncontrolled medical condition (c) Symbicort Single inhaler Maintenance And Reliever Therapy (SMART) therapy (d) shift work with a variable roster (e) pregnancy* or lactation (f) clinically-important visual or auditory impairment *The management of females who become pregnant during the study should be according to clinical need. Due to the possibility that treatment may need to be changed, patients becoming pregnant during the study will be withdrawn. However, since all participants will already be using ICS/LABA, no pregnancy test is required at study start.

Outcome results