Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129987
Status:
COMPLETED
Last Update Posted:
2020-01-29
First Post:
2005-08-11
Brief Title:
Trial of Lay-led Individualised Self-management Education for Adults With Asthma
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
A Multi-centre Randomised Trial of Lay-led Individualised Self-management Education for Adults With Asthma
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None