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

Sponsors and Collaborators: Imperial College London
BUPA
Information provided by: Imperial College London
ClinicalTrials.gov Identifier: NCT00129987

Purpose

Long term conditions often necessitate long term care. In many cases, giving control of their condition to the patient 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-managment education to others with asthma, with outcomes equivalent to those achievable by a nurse.
Condition Intervention
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

Further Study Details: 
Primary Outcomes: unscheduled use of healthcare
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

Eligibility

Ages Eligible for Study:  18 Years   -   90 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00129987


United Kingdom
      NHLI at Charing Cross Hospital Campus, London,  W6 8RF,  United Kingdom; Recruiting
Martyn R Partridge, MD FRCP  0208 846 7181 
Martyn R Partridge, MD FRCP,  Principal Investigator

Study chairs or principal investigators

Martyn R Partridge, MD FRCP,  Principal Investigator,  NHLI Imperial College   

More Information

Publications

Allen D. Telephone follow up for older people discharged from A&E. Nurs Stand. 1997 Aug 6;11(46):34-7.

Alter CL, Fleishman SB, Kornblith AB, Holland JC, Biano D, Levenson R, Vinciguerra V, Rai KR. Supportive telephone intervention for patients receiving chemotherapy. A pilot study. Psychosomatics. 1996 Sep-Oct;37(5):425-31.

Ayres JG, Campbell LM. A controlled assessment of an asthma self-management plan involving a budesonide dose regimen. OPTIONS Research Group. Eur Respir J. 1996 May;9(5):886-92.

Chen JT, Krieger N, Van Den Eeden SK, Quesenberry CP. Different slopes for different folks: socioeconomic and racial/ethnic disparities in asthma and hay fever among 173,859 U.S. men and women. Environ Health Perspect. 2002 Apr;110 Suppl 2:211-6.

Crone S. Launching a national helpline. Health Visit. 1993 Mar;66(3):94-6.

Degner LF, Davison BJ, Sloan JA, Mueller B. Development of a scale to measure information needs in cancer care. J Nurs Meas. 1998 Winter;6(2):137-53.

Field KS, Briggs DJ. Socio-economic and locational determinants of accessibility and utilization of primary health-care. Health Soc Care Community. 2001 Sep;9(5):294-308.

Gibson PG, Coughlan J, Wilson AJ, Abramson M, Bauman A, Hensley MJ, Walters EH. Self-management education and regular practitioner review for adults with asthma. Cochrane Database Syst Rev. 2000;(2):CD001117. Review. Update in: Cochrane Database Syst Rev. 2003;(1):CD001117.

Gilthorpe MS, Lay-Yee R, Wilson RC, Walters S, Griffiths RK, Bedi R. Variations in hospitalization rates for asthma among black and minority ethnic communities. Respir Med. 1998 Apr;92(4):642-8.

Greineder DK, Loane KC, Parks P. Reduction in resource utilization by an asthma outreach program. Arch Pediatr Adolesc Med. 1995 Apr;149(4):415-20.

Howie JG, Heaney DJ, Maxwell M, Walker JJ, Freeman GK, Rai H. Quality at general practice consultations: cross sectional survey. BMJ. 1999 Sep 18;319(7212):738-43.

Howie JG, Heaney DJ, Maxwell M, Walker JJ. A comparison of a Patient Enablement Instrument (PEI) against two established satisfaction scales as an outcome measure of primary care consultations. Fam Pract. 1998 Apr;15(2):165-71.

Juniper EF, Guyatt GH, Cox FM, Ferrie PJ, King DR. Development and validation of the Mini Asthma Quality of Life Questionnaire. Eur Respir J. 1999 Jul;14(1):32-8.

Kesten S, Elias M, Cartier A, Chapman KR. Patient handling of a multidose dry powder inhalation device for albuterol. Chest. 1994 Apr;105(4):1077-81.

Kinnersley P, Stott N, Peters T, Harvey I, Hackett P. A comparison of methods for measuring patient satisfaction with consultations in primary care. Fam Pract. 1996 Feb;13(1):41-51.

Lorig KR, Sobel DS, Stewart AL, Brown BW Jr, Bandura A, Ritter P, Gonzalez VM, Laurent DD, Holman HR. Evidence suggesting that a chronic disease self-management program can improve health status while reducing hospitalization: a randomized trial. Med Care. 1999 Jan;37(1):5-14.

Lorig KR, Mazonson PD, Holman HR. Evidence suggesting that health education for self-management in patients with chronic arthritis has sustained health benefits while reducing health care costs. Arthritis Rheum. 1993 Apr;36(4):439-46.

Madge P, McColl J, Paton J. Impact of a nurse-led home management training programme in children admitted to hospital with acute asthma: a randomised controlled study. Thorax. 1997 Mar;52(3):223-8.

Moudgil H, Honeybourne D. Differences in asthma management between white European and Indian subcontinent ethnic groups living in socioeconomically deprived areas in the Birmingham (UK) conurbation. Thorax. 1998 Jun;53(6):490-4.

Nielsen K, Okamoto L, Shah T. Importance of selected inhaler characteristics and acceptance of a new breath-actuated powder inhalation device. J Asthma. 1997;34(3):249-53.

Partridge MR. An assessment of the feasibility of telephone and email consultation in a chest clinic. Patient Educ Couns. 2004 Jul;54(1):11-3.

Partridge MR. In what way may race, ethnicity or culture influence asthma outcomes? Thorax. 2000 Mar;55(3):175-6. No abstract available.

Partridge MR, Hill SR. Enhancing care for people with asthma: the role of communication, education, training and self-management. 1998 World Asthma Meeting Education and Delivery of Care Working Group. Eur Respir J. 2000 Aug;16(2):333-48. Review.

Pidd H, McGrory KJ, Payne SR. Telephone follow-up after urological surgery. Prof Nurse. 2000 Apr;15(7):449-51.

Saunders KW, Von Korff MV, Grothaus LC. Predictors of participation in primary care group-format back pain self-care interventions. Clin J Pain. 2000 Sep;16(3):236-43.

Scherer YK, Bruce S. Knowledge, attitudes, and self-efficacy and compliance with medical regimen, number of emergency department visits, and hospitalizations in adults with asthma. Heart Lung. 2001 Jul-Aug;30(4):250-7.

Smith E, Alexander V, Booker C, McCowan C, Ogston S, Mukhopadhyay S. Effect of hospital asthma nurse appointment on inpatient asthma care. Respir Med. 2000 Jan;94(1):82-6.

Study ID Numbers:  NHLICX3224
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



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