Methods |
DESIGN: Randomised controlled trial of two interventions
METHOD OF RANDOMISATION: Random numbers list
MEANS OF ALLOCATION CONCEALMENT‐ Adequate
OUTCOME ASSESSOR BLINDING ‐ outcome assessors blinded
WITHDRAWAL/DROPOUTS ‐ all subjects accounted for. |
Participants |
Eligible: not specified
Randomised: 151 (one withdrawn: not asthma)
Completed: 139 (Peak Flow 46, Symptoms Only 45, Control 48)
Age: Overall mean: 36.4 yrs Standard Deviation: 15.9 yrs
Sex: Male / Female ‐ (Peak Flow 17/29, Symptoms Only 20/25, Control 19/29)
Asthma Diagnosis: Doctor's diagnosis and objective lung function
Recruitment: Urgent emergency room treatment for asthma.
Diseases Included: Not specified. Included those who already had a peak flow meter.
Major exclusions: Those who already had a written action plan.
Baseline:
FEV1: not stated
PEF: not stated
Exacerbations All subjects had required urgent treatment for asthma in the previous 12 months. |
Interventions |
Setting: individual nurse led education
Type: Two optimal interventions and an active control.
1. Education (as per control), peak flow self monitoring, medication assessment within the program and advised to seek regular review outside the program and individualised written action plan based on peak flow enabling self adjustment of medications in the event of worsening asthma.
2. Education (as per control), NO symptoms or peak flow self monitoring, medication assessment within the program and advised to seek regular review outside the program and a symptoms based written action plan enabling self adjustment of medications in the event of worsening asthma.
3. Control group: 45 minutes education by the nurse educator about asthma, triggers, medication use and devices as per the interventions above. Medications assessed and if inadequate, patients physician was notified. Patients advised that their dose of corticosteroid may need to be adjusted from time to time.
Duration: 45 minutes one to one counselling sessions for all groups |
Outcomes |
Hospital admissions, ER visits. |
Notes |
Jadad Score: 5 |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Low risk |
Sequentially administered identical opaque closed envelope technique |