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

• ClinicalTrials.gov Identifier: NCT00129987
• Recruitment Status: Completed
• First Posted: August 12, 2005
• Results First Posted: January 29, 2020
• Last Update Posted: January 29, 2020
• Sponsor: Imperial College London
• Collaborator: BUPA Foundation
• Information provided by (Responsible Party): Imperial College London

Study Description

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 567 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Multi-centre Randomised Trial of Lay-led Individualised Self-management Education for Adults With Asthma
• Actual Study Start Date: November 2003
• Actual Primary Completion Date: July 2006
• Actual Study Completion Date: August 2006

Arms and Interventions

Arm	Intervention/treatment
Experimental: Nurse group; An initial consultation of up to 45 min offered either by a practice based primary care nurse, followed by a second shorter face to face consultation and telephone follow-up for 1 year.	Behavioral: Self management education
Experimental: Lay educator group; An initial consultation of up to 45 min offered either by a lay educator, followed by a second shorter face to face consultation and telephone follow-up for 1 year.	Behavioral: Self management education

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Unscheduled Use of Healthcare [ Time Frame: 1 year ]
   Healthcare consists of one or other of hospital admission, emergency department attendance, unscheduled consultation with a GP

Secondary Outcome Measures :

1. Lung Function [ Time Frame: 1 year ]
   (peak flow measurement)
2. Quality of Life Questionnaires [ Time Frame: 1 year ]
   (MISS-21) with Quality of life questionnaires
3. Number of Participants With Use of Asthma Medication [ Time Frame: 1 year ]
   Number of participants with courses of steriod tablets

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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 of Results:

Partridge MR, Caress AL, Brown C, Hennings J, Luker K, Woodcock A, Campbell M. Can lay people deliver asthma self-management education as effectively as primary care based practice nurses? Thorax. 2008 Sep;63(9):778-83. doi: 10.1136/thx.2007.084251. Epub 2008 Feb 15.

Other Publications:

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• Responsible Party: Imperial College London
• ClinicalTrials.gov Identifier: NCT00129987
• Other Study ID Numbers: NHLICX3224
• First Posted: August 12, 2005
• Results First Posted: January 29, 2020
• Last Update Posted: January 29, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

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