Trial Outcomes & Findings for Trial of Lay-led Individualised Self-management Education for Adults With Asthma (NCT NCT00129987)
NCT ID: NCT00129987
Last Updated: 2020-01-29
Results Overview
Healthcare consists of one or other of hospital admission, emergency department attendance, unscheduled consultation with a GP
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
567 participants
Primary outcome timeframe
1 year
Results posted on
2020-01-29
Participant Flow
Participant milestones
| Measure |
Nurse Group
Consultation of asthma patients by nurse
|
Lay Educator Group
Consultation of asthma patients by lay educator
|
|---|---|---|
|
1st Educational Session
STARTED
|
287
|
280
|
|
1st Educational Session
COMPLETED
|
146
|
171
|
|
1st Educational Session
NOT COMPLETED
|
141
|
109
|
|
1 Year
STARTED
|
146
|
171
|
|
1 Year
COMPLETED
|
114
|
150
|
|
1 Year
NOT COMPLETED
|
32
|
21
|
Reasons for withdrawal
| Measure |
Nurse Group
Consultation of asthma patients by nurse
|
Lay Educator Group
Consultation of asthma patients by lay educator
|
|---|---|---|
|
1st Educational Session
Withdrawal by Subject
|
141
|
109
|
|
1 Year
Withdrawal by Subject
|
32
|
21
|
Baseline Characteristics
Trial of Lay-led Individualised Self-management Education for Adults With Asthma
Baseline characteristics by cohort
| Measure |
Nurse Group
n=287 Participants
Consultation of asthma patients by nurse
|
Lay Educator Group
n=280 Participants
Consultation of asthma patients by lay educator
|
Total
n=567 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
251 Participants
n=5 Participants
|
254 Participants
n=7 Participants
|
505 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
36 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
183 Participants
n=5 Participants
|
184 Participants
n=7 Participants
|
367 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
49 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
197 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
404 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
287 participants
n=5 Participants
|
280 participants
n=7 Participants
|
567 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Less participants number due to missing data.
Healthcare consists of one or other of hospital admission, emergency department attendance, unscheduled consultation with a GP
Outcome measures
| Measure |
Nurse Group
n=205 Participants
Consultation of asthma patients by nurse
|
Lay Educator Group
n=213 Participants
Consultation of asthma patients by lay educator
|
|---|---|---|
|
Number of Participants With Unscheduled Use of Healthcare
|
61 Participants
|
65 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Data not collected
(peak flow measurement)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Data not collected
(MISS-21) with Quality of life questionnaires
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Less participants number due to missing data.
Number of participants with courses of steriod tablets
Outcome measures
| Measure |
Nurse Group
n=205 Participants
Consultation of asthma patients by nurse
|
Lay Educator Group
n=213 Participants
Consultation of asthma patients by lay educator
|
|---|---|---|
|
Number of Participants With Use of Asthma Medication
|
60 Participants
|
62 Participants
|
Adverse Events
Nurse Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lay Educator Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place