Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
04/016
Study information
Scientific title
Does structured advice on Allergy and Allergen Avoidance given by practice nurses improve control of asthma in primary care? A single blind randomised controlled trial
Acronym
AAA
Study hypothesis
The control of asthma can be improved by a structured allergy assessment followed by individualised avoidance advice, given by practice nurses in primary care.
Ethics approval
Ethics approval received from Bristol South NHS Ethics Committee on the 15th November 2004.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Asthma
Intervention
Control patients:
Usual care asthma reviews (UC) consisted of assessment of symptoms, inhaler technique, and medication usage, and provision of self-management action plans.
Intervention patients:
Structured allergen and trigger avoidance advice reviews (AAA) comprised the elements of a usual review as above, supplemented by a structured asthma and allergy assessment consisting of:
1. Skin prick testing
2. Completion of the Structured Allergy Questionnaire and Asthma Trigger Inventory
3. Avoidance advice for identified triggers
Duration of these was about 30 - 45 minutes. There was no further contact with the nurse until follow up 4 months later.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Lung function/symptoms, assessed at 4 months.
Secondary outcome measures
Self efficacy, assessed at 4 months.
Overall trial start date
01/01/2005
Overall trial end date
01/01/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Diagnosis of asthma, confirmed by 20% peak expiratory flow [PEF] diurnal variation in medical records or 15% reversibility on spirometry (British Thoracic Society [BTS]/Scottish Intercollegiate Guidelines Network [SIGN] 2003)
2. Prescribed asthma medication within the past year
3. Aged between 16 to 55 years, either sex
4. Not had skin prick testing in the past 10 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
Unable to give informed consent.
Recruitment start date
01/01/2005
Recruitment end date
01/01/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Centre for Health Sciences
London
E1 4NS
United Kingdom
Sponsor information
Organisation
St George's Hospital Medical School (UK)
Sponsor details
Cranmer Terrace
London
SW17 0RE
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Asthma UK (UK) (ref: 04/016)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19793085
Publication citations
-
Results
Bobb C, Ritz T, Rowlands G, Griffiths C, Effects of allergen and trigger factor avoidance advice in primary care on asthma control: a randomized-controlled trial., Clin. Exp. Allergy, 2010, 40, 1, 143-152, doi: 10.1111/j.1365-2222.2009.03350.x.