A Multi-Centre Randomised Trial of Lay-Led Individualised Self-Management Education for Adults with Asthma - Article
Clinical Trial: A Multi-Centre Randomised Trial of Lay-Led Individualised Self-Management Education for Adults with Asthma
This study is currently recruiting patients.
Verified by Imperial College London August 2005
|Asthma || Behavior: Self management education |
MedlinePlus related topics: Asthma
Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Open Label, Active Control, Single Group Assignment
Secondary Outcomes: Lung function (peak flow); Quality of life questionnaires (MISS-21); use of asthma medication
Expected Total Enrollment: 640
Study start: November 2003; Expected completion: January 2007
Last follow-up: August 2006; Data entry closure: January 2007
This study will be a randomised controlled trial looking for equivalence, our central hypothesis is that lay-led educatation will be at least equivalent to professional-led education in terms of patient outcomes. Patients will be randomised to receive either lay-led or professional led self-management education. Patients will be followed up longitudinally for 12 months from initial intervention. Two sites were studied; Manchester and London. It is anticipated that 16 sites will be recruited in each of the two geographical areas, all sites will have an asthma register. Individuals will be eligible for inclusion if they are adults; have clinician diagnosed asthma; have persistant disease and require regular therapy, with some evidence of variability in their disease, such that a self management plan would be appropriate. Both genders will be eligible, as will those unable to see or read. Individuals will be excluded if they have severe cognitive impairment; they decline to be randomised; they decline to receive asthma education and follow-up sole from the designated educator, other than in an emergency situation, their condition does not show variability.
The intervention in the study will be a disease-specific asthma self-management education programme delivery either by a professional (ie practice nurse) or a lay educator. Both lay and professional trainers will receive specific training in the content and delivery of this intervention. The intervention will consist of an initial 45 minute training session (including receipt of a written personal asthma action plan); a second face to face reinforcing session 3 weeks after the first session; 3 monthly telephone follow-up appointments to reinforce messages and to give ongoing advice with availability of the nurse or lay educator as a source of advice at all other times. Data will be collected on unscheduled use of health care, peak flow readings,patients self-reporting of "adverse events", RCP three questions, perceptions of the interviews using MISS-21, QOL questionnaire and AQLQ. Demographics for all patients will also be recorded
Accepts Healthy Volunteers
Adults step two therapy (BTS) Evidence of poorly controlled disease
Unable to benefit from self management education Other respiratory conditions other than asthma
Location and Contact Information
NHLI at Charing Cross Hospital Campus, London, W6 8RF, United Kingdom; Recruiting
Martyn R Partridge, MD FRCP, Principal Investigator
Martyn R Partridge, MD FRCP, Principal Investigator, NHLI Imperial College
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Last Updated: August 11, 2005
Record first received: August 11, 2005
ClinicalTrials.gov Identifier: NCT00129987
Health Authority: United Kingdom: Research Ethics Committee
ClinicalTrials.gov processed this record on 2005-08-23