Condition category
Respiratory
Date applied
13/02/2008
Date assigned
26/02/2008
Last edited
21/06/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Chris Griffiths

ORCID ID

Contact details

Centre for Health Sciences
Barts and the London Medical School
2 Newark st
London
E1 4NS
United Kingdom

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 measures

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

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

http://www.sgul.ac.uk/

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

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

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19793085

Publication citations

  1. 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.

Additional files

Editorial Notes