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

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Self management education
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma focused on measuring Asthma

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • NHLI at Charing Cross Hospital Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Nurse group

Lay educator group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Lung Function
(peak flow measurement)
Quality of Life Questionnaires
(MISS-21) with Quality of life questionnaires
Number of Participants With Use of Asthma Medication
Number of participants with courses of steriod tablets

Full Information

First Posted
August 11, 2005
Last Updated
January 17, 2020
Sponsor
Imperial College London
Collaborators
BUPA Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00129987
Brief Title
Trial of Lay-led Individualised Self-management Education for Adults With Asthma
Official Title
A Multi-centre Randomised Trial of Lay-led Individualised Self-management Education for Adults With Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 2003 (Actual)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
BUPA Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
567 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nurse group
Arm Type
Experimental
Arm Description
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.
Arm Title
Lay educator group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self management education
Primary Outcome Measure Information:
Title
Number of Participants With Unscheduled Use of Healthcare
Description
Healthcare consists of one or other of hospital admission, emergency department attendance, unscheduled consultation with a GP
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Lung Function
Description
(peak flow measurement)
Time Frame
1 year
Title
Quality of Life Questionnaires
Description
(MISS-21) with Quality of life questionnaires
Time Frame
1 year
Title
Number of Participants With Use of Asthma Medication
Description
Number of participants with courses of steriod tablets
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martyn R Partridge, MD FRCP
Organizational Affiliation
NHLI Imperial College
Official's Role
Principal Investigator
Facility Information:
Facility Name
NHLI at Charing Cross Hospital Campus
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
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Trial of Lay-led Individualised Self-management Education for Adults With Asthma

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