Trial of Lay-led Individualised Self-management Education for Adults With Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00129987
Recruitment Status : Completed
First Posted : August 12, 2005
Last Update Posted : June 8, 2015
BUPA Foundation
Information provided by:
Imperial College London

Brief Summary:
Long term conditions often necessitate long term care. In many cases, giving control of their conditions to the patients themselves produces the best outcomes. Such patient education and the acquisition of self-management skills can be time consuming and the evidence suggests that the process is often not undertaken by doctors. Sometimes it is delegated to nursing colleagues, but all health professionals are in short supply. Patients carry credibility as a resource and this project is designed to determine, by means of a multi-centre randomised controlled trial, whether well trained lay educators can deliver training in self-management education to others with asthma, with outcomes equivalent to those achievable by a nurse.

Condition or disease Intervention/treatment Phase
Asthma Behavioral: Self management education Not Applicable

Detailed Description:

This study will be a randomised controlled trial looking for equivalence; the investigators' central hypothesis is that lay-led education 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 persistent 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 solely from the designated educator, other than in an emergency situation, or 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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 640 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Multi-centre Randomised Trial of Lay-led Individualised Self-management Education for Adults With Asthma
Study Start Date : November 2003
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Primary Outcome Measures :
  1. Unscheduled use of healthcare

Secondary Outcome Measures :
  1. Lung function (peak flow)
  2. Quality of life questionnaires (MISS-21)
  3. Use of asthma medication

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Adults step two therapy (BTS)
  • Evidence of poorly controlled disease

Exclusion Criteria:

  • Unable to benefit from self management education
  • Other respiratory conditions other than asthma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00129987

United Kingdom
NHLI at Charing Cross Hospital Campus
London, United Kingdom, W6 8RF
Sponsors and Collaborators
Imperial College London
BUPA Foundation
Principal Investigator: Martyn R Partridge, MD FRCP NHLI Imperial College

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Office of National Statistics (1999) Hospital Episode Statistics London: The Stationery Office
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Pearson MG and Bucknall CE (1999) Measuring clinical outcome in asthma - a patient focused approach. London: Royal College of Physicians of London
Polit DF and Hungler BP (1996) Essentials of Nursing Research. Methods, Appraisal and Utilization (4th ed) Philadelphia: JB Lippincott Co
Price D (2000) Needs of People with Asthma Survey Asthma

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00129987     History of Changes
Other Study ID Numbers: NHLICX3224
First Posted: August 12, 2005    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: May 2008

Keywords provided by Imperial College London:

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases