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

Asthma Clinical Trial

Official title:

A Multi-centre Randomised Trial of Lay-led Individualised Self-management Education for Adults With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00129987
• Other study ID #: NHLICX3224
• Status: Completed
• Phase: N/A
• Start date: November 2003
• Est. completion date: August 2006

Study information

• Verified date: January 2020
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 567
• Est. completion date: August 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• Self management education

Locations

Country	Name	City	State
United Kingdom	NHLI at Charing Cross Hospital Campus	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	BUPA Foundation

Country where clinical trial is conducted

United Kingdom, 

References & Publications (47)

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* Note: There are 47 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Unscheduled Use of Healthcare	Healthcare consists of one or other of hospital admission, emergency department attendance, unscheduled consultation with a GP	1 year
Secondary	Lung Function	(peak flow measurement)	1 year
Secondary	Quality of Life Questionnaires	(MISS-21) with Quality of life questionnaires	1 year
Secondary	Number of Participants With Use of Asthma Medication	Number of participants with courses of steriod tablets	1 year