Trial of Lay-Led Individualised Self-Management Education for Adults With Asthma

This study has been completed.
Sponsor:
Collaborator:
BUPA Foundation
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00129987
First received: August 11, 2005
Last updated: May 8, 2008
Last verified: May 2008
  Purpose

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 Intervention
Asthma
Behavioral: Self management education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Multi-Centre Randomised Trial of Lay-Led Individualised Self-Management Education for Adults With Asthma

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Unscheduled use of healthcare

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

Estimated Enrollment: 640
Study Start Date: November 2003
Estimated Study Completion Date: August 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129987

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

Publications:
British Thoracic Society, National Asthma Campaign et al (1997) The British Guidelines on Asthma Management 1995 Review and Position Statement Thorax 52 (suppl 1): S1 -S21
Caress A, Beaver K, Woodcock A, Luker K (2002a) A descriptive study of treatment decision-making role preference in adult asthma patients American Journal of Respiratory and Critical Care Medicine 165 (8) A420
Caress A, Beaver K, Luker K and Woodcock A (2002b) A cross-sectional survey of priority information needs in adult asthma patients American Journal of Respiratory and Critical Care Medicine 165 (8) A43
Denzin N. (1970) The Research Act: A Theoretical Introduction to Social Research Chicago: Aldine
Department of Health (2001) The Expert Patient: a New Approach to Chronic Disease Management for the 21st Century London: The Stationery Office
Drummond MF, O'Brien B, Stoddart GL, Torrance GW (1997) Methods for the Economic Evaluation of Healthcare Programmes Oxford: Oxford University Press
Gold MR, Siegel JE, Russell LB, Weinstein MC (1996) Cost-Effectiveness in Health and Medicine Oxford: Oxford University Press
Kaplan et al (1995) Medical Care 33: 1176-1187
Miles MB, Huberman AM (1984) Qualitative data analysis: a sourcebook of new methods London: Sage
National Asthma Campaign (2001a) Out in the Open: a true picture of asthma in the United Kingdom today, The National Asthma Campaign Asthma Audit 2001 The Asthma Journal 6 (3 Special Supplement) whole issue
National Asthma Campaign (2001b) Asthma - who's in control. Review of evidence for the use of asthma self management London: National Asthma Campaign
Office of National Statistics (1999) Hospital Episode Statistics London: The Stationery Office
Office of National Statistics (1998) Key Health Statistics from General Practice (Series MB2, No 6) London: The Stationery Office
Oldam D (1997) Nurse-led asthma clinic in an Asian community Nursing Times 93 (13): 58-59 Ormerod LP, Myers P, Prescott RJ (1999) Prevalence of asthma and 'probable' Asthma in the Asian population in Blackburn, U.K. Respiratory Medicine 93 (1): 16-20
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

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00129987     History of Changes
Other Study ID Numbers: NHLICX3224
Study First Received: August 11, 2005
Last Updated: May 8, 2008
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
Asthma

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

ClinicalTrials.gov processed this record on August 27, 2014