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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00129987
Enrollment
567
Registered
2005-08-12
Start date
2003-11-30
Completion date
2006-08-31
Last updated
2020-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma

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.

Interventions

Sponsors

BUPA Foundation
CollaboratorOTHER
Imperial College London
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Unscheduled Use of Healthcare1 yearHealthcare consists of one or other of hospital admission, emergency department attendance, unscheduled consultation with a GP

Secondary

MeasureTime frameDescription
Lung Function1 year(peak flow measurement)
Quality of Life Questionnaires1 year(MISS-21) with Quality of life questionnaires
Number of Participants With Use of Asthma Medication1 yearNumber of participants with courses of steriod tablets

Countries

United Kingdom

Participant flow

Participants by arm

ArmCount
Nurse Group
Consultation of asthma patients by nurse
287
Lay Educator Group
Consultation of asthma patients by lay educator
280
Total567

Withdrawals & dropouts

PeriodReasonFG000FG001
1st Educational SessionWithdrawal by Subject141109
1 YearWithdrawal by Subject3221

Baseline characteristics

CharacteristicNurse GroupLay Educator GroupTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
36 Participants26 Participants62 Participants
Age, Categorical
Between 18 and 65 years
251 Participants254 Participants505 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
49 Participants42 Participants91 Participants
Race (NIH/OMB)
Black or African American
26 Participants20 Participants46 Participants
Race (NIH/OMB)
More than one race
10 Participants4 Participants14 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants7 Participants12 Participants
Race (NIH/OMB)
White
197 Participants207 Participants404 Participants
Region of Enrollment
United Kingdom
287 participants280 participants567 participants
Sex: Female, Male
Female
104 Participants96 Participants200 Participants
Sex: Female, Male
Male
183 Participants184 Participants367 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2050 / 213
other
Total, other adverse events
0 / 2050 / 213
serious
Total, serious adverse events
0 / 2050 / 213

Outcome results

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

Time frame: 1 year

Population: Less participants number due to missing data.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Nurse GroupNumber of Participants With Unscheduled Use of Healthcare61 Participants
Lay Educator GroupNumber of Participants With Unscheduled Use of Healthcare65 Participants
Secondary

Lung Function

(peak flow measurement)

Time frame: 1 year

Population: Data not collected

Secondary

Number of Participants With Use of Asthma Medication

Number of participants with courses of steriod tablets

Time frame: 1 year

Population: Less participants number due to missing data.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Nurse GroupNumber of Participants With Use of Asthma Medication60 Participants
Lay Educator GroupNumber of Participants With Use of Asthma Medication62 Participants
Secondary

Quality of Life Questionnaires

(MISS-21) with Quality of life questionnaires

Time frame: 1 year

Population: Data not collected

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026