| Methods |
DESIGN: Randomised controlled trial of two interventions
METHOD OF RANDOMISATION: Stratified by treatment centre, randomisation method not stated. Control group not randomised.
MEANS OF ALLOCATION CONCEALMENT‐ not stated, control group open
OUTCOME ASSESSOR BLINDING ‐
WITHDRAWAL/DROPOUTS ‐ |
| Participants |
Eligible: not stated
Randomised: 126 (Intervention LE ?, intervention SE ?)
Completed: 98 ( Intervention LE 30, intervention SE 33, control 35)
Age: Overall mean: 34.5 yrs Range: >18 yrs
Sex: Male / Female ‐
Asthma Diagnosis: Doctor diagnosis
Recruitment: ER or outpatient clinic with exacerbation
Diseases Included:
Major exclusions: > 40yrs with FEV1 <80% (to avoid COPD), any concurrent illness
Baseline: Mean duration asthma 10.2 yrs.
FEV1:
PEF: % predicted: Intervention LE 89.8%, Intervention SE 89.8%
Exacerbations: admitted with acute exacerbations |
| Interventions |
Setting: 2 university hospitals
Type: 2 interventions and a non randomised control group.
Intervention LE: Limited education but including action plan‐ instructed in use of inhaler, explanation of self action plan by physician. Choice of action plan based on symptoms or PEF. Received standard care with therapy modified according to action plan.
Intervention SE: Included the LE intervention plus self management education ‐ a structured educational program based on the 'PRECEDE model'‐ including predisposing factors, enabling factors and reinforcement.
Control group received usual care. ‐ not used as not randomised
Duration: SE intervention conducted 2 weeks after randomisation ‐ length of time not stated. Reinforced at 6 months |
| Outcomes |
Knowledge,ER visits, unscheduled Dr visits, PEF, quality of life
compliance |
| Notes |
Jadad Score: 4 |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
Information not available |
