Trial Outcomes & Findings for Symptom Perception (NCT NCT03646669)
NCT ID: NCT03646669
Last Updated: 2023-05-06
Results Overview
Change in self-reported asthma control validated survey, with a total score range from 0-6, with a higher score indicating severely uncontrolled asthma , used to assess current asthma control at pre-intervention, 1week post-pilot follow up visit and 4 weeks post-pilot follow-up visit
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
58 participants
Primary outcome timeframe
Baseline, 1 week follow up, 1 month follow up
Results posted on
2023-05-06
Participant Flow
Participant milestones
| Measure |
Asthma Education and PEF Feedback
Patients receive asthma education and personal Peak expiratory flow (PEF) feedback
PEF Feedback: Patients in the PEF feedback arm will receive a one-time session including asthma management education, discussion of their asthma symptoms, review of individual PEF results and perception of symptoms, and problem-solving techniques to improve asthma self-management. After the session, the participants in this arm will be able to view in the display of the AM2 device their PEF values and will be instructed to mentally note their actual results with their pre-effort estimated BPF. They will also set a motivational message for themselves that will appear on the device.
|
Asthma Education
No PEF feedback arm
Asthma education: General asthma education, AM2 training, and positive counseling, but no discussion linking asthma symptom perception to SMB. Following the session, these participants will use the AM2 to track PEF actual and perceived values twice per day, but they will be blinded to the actual PEF values. Control arm patients will see a standard motivational message appear on the screen of the AM2 device.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
25
|
|
Overall Study
COMPLETED
|
28
|
25
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
| Measure |
Asthma Education and PEF Feedback
Patients receive asthma education and personal Peak expiratory flow (PEF) feedback
PEF Feedback: Patients in the PEF feedback arm will receive a one-time session including asthma management education, discussion of their asthma symptoms, review of individual PEF results and perception of symptoms, and problem-solving techniques to improve asthma self-management. After the session, the participants in this arm will be able to view in the display of the AM2 device their PEF values and will be instructed to mentally note their actual results with their pre-effort estimated BPF. They will also set a motivational message for themselves that will appear on the device.
|
Asthma Education
No PEF feedback arm
Asthma education: General asthma education, AM2 training, and positive counseling, but no discussion linking asthma symptom perception to SMB. Following the session, these participants will use the AM2 to track PEF actual and perceived values twice per day, but they will be blinded to the actual PEF values. Control arm patients will see a standard motivational message appear on the screen of the AM2 device.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
0
|
Baseline Characteristics
Symptom Perception
Baseline characteristics by cohort
| Measure |
Asthma Education and PEF Feedback
n=28 Participants
Patients receive asthma education and personal Peak expiratory flow (PEF) feedback
PEF Feedback: Patients in the PEF feedback arm will receive a one-time session including asthma management education, discussion of their asthma symptoms, review of individual PEF results and perception of symptoms, and problem-solving techniques to improve asthma self-management. After the session, the participants in this arm will be able to view in the display of the AM2 device their PEF values and will be instructed to mentally note their actual results with their pre-effort estimated BPF. They will also set a motivational message for themselves that will appear on the device.
|
Asthma Education
n=25 Participants
No PEF feedback arm
Asthma education: General asthma education, AM2 training, and positive counseling, but no discussion linking asthma symptom perception to SMB. Following the session, these participants will use the AM2 to track PEF actual and perceived values twice per day, but they will be blinded to the actual PEF values. Control arm patients will see a standard motivational message appear on the screen of the AM2 device.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.0 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
65.7 years
STANDARD_DEVIATION 5.6 • n=7 Participants
|
66.3 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 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
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Education
Less than high school
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Education
High school graduate
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Education
Some college
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Education
College graduate or higher degree
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Education
Unknown or Not reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Monthly Income
≤$1500
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Monthly Income
>$1500
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Monthly Income
Unknown or Not reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Marital Status
Married
|
13 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Marital Status
Single/Divorced/Widowed
|
14 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Marital Status
Unknown or Not reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Health Insurance
Medicaid or Medicare
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Health Insurance
Private or Other
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Health Insurance
No insurance
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Health Insurance
Unknown or Not reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 week follow up, 1 month follow upPopulation: data not available for participants with missing questionnaire
Change in self-reported asthma control validated survey, with a total score range from 0-6, with a higher score indicating severely uncontrolled asthma , used to assess current asthma control at pre-intervention, 1week post-pilot follow up visit and 4 weeks post-pilot follow-up visit
Outcome measures
| Measure |
Asthma Education and PEF Feedback
n=28 Participants
Patients receive asthma education and personal Peak expiratory flow (PEF) feedback
PEF Feedback: Patients in the PEF feedback arm will receive a one-time session including asthma management education, discussion of their asthma symptoms, review of individual PEF results and perception of symptoms, and problem-solving techniques to improve asthma self-management. After the session, the participants in this arm will be able to view in the display of the AM2 device their PEF values and will be instructed to mentally note their actual results with their pre-effort estimated BPF. They will also set a motivational message for themselves that will appear on the device.
|
Asthma Education
n=25 Participants
No PEF feedback arm
Asthma education: General asthma education, AM2 training, and positive counseling, but no discussion linking asthma symptom perception to SMB. Following the session, these participants will use the AM2 to track PEF actual and perceived values twice per day, but they will be blinded to the actual PEF values. Control arm patients will see a standard motivational message appear on the screen of the AM2 device.
|
|---|---|---|
|
Asthma Control Questionnaire (ACQ)
Baseline
|
1.2 score on a scale
Standard Deviation 1.1
|
1.4 score on a scale
Standard Deviation 1.0
|
|
Asthma Control Questionnaire (ACQ)
1 week follow up
|
0.8 score on a scale
Standard Deviation 0.8
|
1.4 score on a scale
Standard Deviation 0.8
|
|
Asthma Control Questionnaire (ACQ)
1 month follow up
|
0.6 score on a scale
Standard Deviation 0.5
|
1.6 score on a scale
Standard Deviation 0.9
|
PRIMARY outcome
Timeframe: Baseline, 1 week follow up, 1 month follow upPopulation: data not available for participants with missing questionnaire
Change in self-reported asthma-related quality of life validated survey used to assess asthma-related quality of life at at pre-intervention, 1week post-pilot follow up visit and 4 weeks post-pilot follow-up visit. Total Score from 1-7, with higher score indicating better quality of life.
Outcome measures
| Measure |
Asthma Education and PEF Feedback
n=28 Participants
Patients receive asthma education and personal Peak expiratory flow (PEF) feedback
PEF Feedback: Patients in the PEF feedback arm will receive a one-time session including asthma management education, discussion of their asthma symptoms, review of individual PEF results and perception of symptoms, and problem-solving techniques to improve asthma self-management. After the session, the participants in this arm will be able to view in the display of the AM2 device their PEF values and will be instructed to mentally note their actual results with their pre-effort estimated BPF. They will also set a motivational message for themselves that will appear on the device.
|
Asthma Education
n=25 Participants
No PEF feedback arm
Asthma education: General asthma education, AM2 training, and positive counseling, but no discussion linking asthma symptom perception to SMB. Following the session, these participants will use the AM2 to track PEF actual and perceived values twice per day, but they will be blinded to the actual PEF values. Control arm patients will see a standard motivational message appear on the screen of the AM2 device.
|
|---|---|---|
|
Change in Asthma Quality of Life Questionnaire (AQLQ)
Baseline
|
5.2 score on a scale
Standard Deviation 1.2
|
5.0 score on a scale
Standard Deviation 1.0
|
|
Change in Asthma Quality of Life Questionnaire (AQLQ)
1 week follow up
|
5.6 score on a scale
Standard Deviation 1.4
|
4.9 score on a scale
Standard Deviation 1.1
|
|
Change in Asthma Quality of Life Questionnaire (AQLQ)
1 month follow up
|
5.7 score on a scale
Standard Deviation 1.1
|
5.0 score on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Baseline, 1 week follow up, 1 month follow upPopulation: data not available for participants with missing questionnaire
MARS is a self-reported questionnaire with the total score range from 0-10 with a higher score indicating better adherence.
Outcome measures
| Measure |
Asthma Education and PEF Feedback
n=28 Participants
Patients receive asthma education and personal Peak expiratory flow (PEF) feedback
PEF Feedback: Patients in the PEF feedback arm will receive a one-time session including asthma management education, discussion of their asthma symptoms, review of individual PEF results and perception of symptoms, and problem-solving techniques to improve asthma self-management. After the session, the participants in this arm will be able to view in the display of the AM2 device their PEF values and will be instructed to mentally note their actual results with their pre-effort estimated BPF. They will also set a motivational message for themselves that will appear on the device.
|
Asthma Education
n=25 Participants
No PEF feedback arm
Asthma education: General asthma education, AM2 training, and positive counseling, but no discussion linking asthma symptom perception to SMB. Following the session, these participants will use the AM2 to track PEF actual and perceived values twice per day, but they will be blinded to the actual PEF values. Control arm patients will see a standard motivational message appear on the screen of the AM2 device.
|
|---|---|---|
|
Change in Medication Adherence Rating Scale (MARS)
Baseline
|
4.0 score on a scale
Standard Deviation 1.0
|
4.2 score on a scale
Standard Deviation 0.8
|
|
Change in Medication Adherence Rating Scale (MARS)
1 week follow up
|
4.4 score on a scale
Standard Deviation 0.7
|
4.3 score on a scale
Standard Deviation 0.8
|
|
Change in Medication Adherence Rating Scale (MARS)
1 month follow up
|
4.2 score on a scale
Standard Deviation 0.6
|
4.4 score on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Baseline, 1 week follow up, 1 month follow upPopulation: data not available for participants with missing questionnaire
10-item scale that measures beliefs about asthma controller medication in 2 subdomains: necessity and concerns. All items have a five-point Likert answer option, ranging from 1 = strongly disagree to 5 = strongly agree, with total range from 10 to 50, with higher scores indicate stronger beliefs about the corresponding concepts.
Outcome measures
| Measure |
Asthma Education and PEF Feedback
n=28 Participants
Patients receive asthma education and personal Peak expiratory flow (PEF) feedback
PEF Feedback: Patients in the PEF feedback arm will receive a one-time session including asthma management education, discussion of their asthma symptoms, review of individual PEF results and perception of symptoms, and problem-solving techniques to improve asthma self-management. After the session, the participants in this arm will be able to view in the display of the AM2 device their PEF values and will be instructed to mentally note their actual results with their pre-effort estimated BPF. They will also set a motivational message for themselves that will appear on the device.
|
Asthma Education
n=25 Participants
No PEF feedback arm
Asthma education: General asthma education, AM2 training, and positive counseling, but no discussion linking asthma symptom perception to SMB. Following the session, these participants will use the AM2 to track PEF actual and perceived values twice per day, but they will be blinded to the actual PEF values. Control arm patients will see a standard motivational message appear on the screen of the AM2 device.
|
|---|---|---|
|
Change in Beliefs About Medicines Questionnaire (BMQ) - Necessity Score and Concerns Score
Necessity 1 week follow up
|
18.9 score on a scale
Standard Deviation 4.3
|
17.2 score on a scale
Standard Deviation 4.5
|
|
Change in Beliefs About Medicines Questionnaire (BMQ) - Necessity Score and Concerns Score
Necessity 1 month follow up
|
18.4 score on a scale
Standard Deviation 4.5
|
18.1 score on a scale
Standard Deviation 5.2
|
|
Change in Beliefs About Medicines Questionnaire (BMQ) - Necessity Score and Concerns Score
Concerns 1 week follow up
|
13.0 score on a scale
Standard Deviation 4.4
|
12.9 score on a scale
Standard Deviation 4.5
|
|
Change in Beliefs About Medicines Questionnaire (BMQ) - Necessity Score and Concerns Score
Concerns 1 month follow up
|
13.6 score on a scale
Standard Deviation 4.2
|
12.8 score on a scale
Standard Deviation 4.0
|
|
Change in Beliefs About Medicines Questionnaire (BMQ) - Necessity Score and Concerns Score
Necessity Baseline
|
17.4 score on a scale
Standard Deviation 4.9
|
18.2 score on a scale
Standard Deviation 4.4
|
|
Change in Beliefs About Medicines Questionnaire (BMQ) - Necessity Score and Concerns Score
Concerns Baseline
|
14.2 score on a scale
Standard Deviation 4.2
|
14.5 score on a scale
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: Baseline, 1 week follow upPopulation: data not available for participants with missing questionnaire
The BIPQ includes 9 items designed to rapidly assess the cognitive and emotional representations of illness- consequences, timeline, personal control, treatment control, experience symptoms, concerns, emotions and comprehensibility. For analyses, the first 8 items are summed and item 9 which is part of the causal scale is excluded. Items for personal control, treatment control and comprehensibility were reverse coded. All of the 8 items, are rated using a 0 (none) to 10 (extreme) response scale giving a sum total score of 0-80. Higher total scores indicate worse asthma perception.
Outcome measures
| Measure |
Asthma Education and PEF Feedback
n=28 Participants
Patients receive asthma education and personal Peak expiratory flow (PEF) feedback
PEF Feedback: Patients in the PEF feedback arm will receive a one-time session including asthma management education, discussion of their asthma symptoms, review of individual PEF results and perception of symptoms, and problem-solving techniques to improve asthma self-management. After the session, the participants in this arm will be able to view in the display of the AM2 device their PEF values and will be instructed to mentally note their actual results with their pre-effort estimated BPF. They will also set a motivational message for themselves that will appear on the device.
|
Asthma Education
n=25 Participants
No PEF feedback arm
Asthma education: General asthma education, AM2 training, and positive counseling, but no discussion linking asthma symptom perception to SMB. Following the session, these participants will use the AM2 to track PEF actual and perceived values twice per day, but they will be blinded to the actual PEF values. Control arm patients will see a standard motivational message appear on the screen of the AM2 device.
|
|---|---|---|
|
Change in Beliefs About Illness Perception Questionnaire (BIPQ)
Baseline
|
33.3 score on a scale
Standard Deviation 13.9
|
34.0 score on a scale
Standard Deviation 0.7
|
|
Change in Beliefs About Illness Perception Questionnaire (BIPQ)
1 week follow up
|
30.7 score on a scale
Standard Deviation 13.9
|
34.7 score on a scale
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: Baseline, 1 week follow up, 1 month follow upPopulation: data not available for participants with missing questionnaire
Assessed based on alignment of patient guesses and actual PEF values recorded by the AM2 device and then categorizing into accurate, under or over-perception, adjusted for age, sex, race, monthly income Assesses if training and feedback can improve under perception of airflow obstruction and lead to better control in older adults with asthma
Outcome measures
| Measure |
Asthma Education and PEF Feedback
n=28 Participants
Patients receive asthma education and personal Peak expiratory flow (PEF) feedback
PEF Feedback: Patients in the PEF feedback arm will receive a one-time session including asthma management education, discussion of their asthma symptoms, review of individual PEF results and perception of symptoms, and problem-solving techniques to improve asthma self-management. After the session, the participants in this arm will be able to view in the display of the AM2 device their PEF values and will be instructed to mentally note their actual results with their pre-effort estimated BPF. They will also set a motivational message for themselves that will appear on the device.
|
Asthma Education
n=25 Participants
No PEF feedback arm
Asthma education: General asthma education, AM2 training, and positive counseling, but no discussion linking asthma symptom perception to SMB. Following the session, these participants will use the AM2 to track PEF actual and perceived values twice per day, but they will be blinded to the actual PEF values. Control arm patients will see a standard motivational message appear on the screen of the AM2 device.
|
|---|---|---|
|
Symptom Perception Measures Adjusted
Symptom Accurate Perception Baseline
|
55.3 percent
Standard Error 6.5
|
51.1 percent
Standard Error 6.9
|
|
Symptom Perception Measures Adjusted
Symptom Accurate Perception 1 month follow up
|
72.2 percent
Standard Error 7.6
|
42.9 percent
Standard Error 8.3
|
|
Symptom Perception Measures Adjusted
Symptom Over-Perception 1 week follow up
|
16.6 percent
Standard Error 4.9
|
13.6 percent
Standard Error 5
|
|
Symptom Perception Measures Adjusted
Actual Best, personal best 1 month follow up
|
78.6 percent
Standard Error 0.5
|
67.7 percent
Standard Error 0.7
|
|
Symptom Perception Measures Adjusted
Symptom Accurate Perception 1 week follow up
|
71.5 percent
Standard Error 6.3
|
52.7 percent
Standard Error 6.4
|
|
Symptom Perception Measures Adjusted
Symptom Under-Perception Baseline
|
39.7 percent
Standard Error 7
|
44.9 percent
Standard Error 7.5
|
|
Symptom Perception Measures Adjusted
Symptom Under-Perception 1 week follow up
|
11.9 percent
Standard Error 6.4
|
33.8 percent
Standard Error 6.4
|
|
Symptom Perception Measures Adjusted
Symptom Under-Perception 1 month follow up
|
11.8 percent
Standard Error 7.4
|
45.1 percent
Standard Error 8.0
|
|
Symptom Perception Measures Adjusted
Symptom Over-Perception Baseline
|
5.0 percent
Standard Error 2.1
|
3.9 percent
Standard Error 2.3
|
|
Symptom Perception Measures Adjusted
Symptom Over-Perception 1 month follow up
|
16 percent
Standard Error 5.9
|
12 percent
Standard Error 6.4
|
|
Symptom Perception Measures Adjusted
Actual Best, personal best baseline
|
67 percent
Standard Error 0.4
|
68.2 percent
Standard Error 0.6
|
|
Symptom Perception Measures Adjusted
Actual Best, personal best 1 week follow up
|
80.8 percent
Standard Error 0.6
|
71.9 percent
Standard Error 0.7
|
SECONDARY outcome
Timeframe: Baseline, 1 week follow up, 1 month follow upPopulation: data not available for participants with missing questionnaire
Change in self-reported asthma control validated survey, with a total score range from 0-6, with a higher score indicating severely uncontrolled asthma, used to assess current asthma control at pre-intervention, 1week post-pilot follow up visit and 4 weeks post-pilot follow-up visit adjusted for age, sex, race, monthly income
Outcome measures
| Measure |
Asthma Education and PEF Feedback
n=28 Participants
Patients receive asthma education and personal Peak expiratory flow (PEF) feedback
PEF Feedback: Patients in the PEF feedback arm will receive a one-time session including asthma management education, discussion of their asthma symptoms, review of individual PEF results and perception of symptoms, and problem-solving techniques to improve asthma self-management. After the session, the participants in this arm will be able to view in the display of the AM2 device their PEF values and will be instructed to mentally note their actual results with their pre-effort estimated BPF. They will also set a motivational message for themselves that will appear on the device.
|
Asthma Education
n=25 Participants
No PEF feedback arm
Asthma education: General asthma education, AM2 training, and positive counseling, but no discussion linking asthma symptom perception to SMB. Following the session, these participants will use the AM2 to track PEF actual and perceived values twice per day, but they will be blinded to the actual PEF values. Control arm patients will see a standard motivational message appear on the screen of the AM2 device.
|
|---|---|---|
|
Asthma Control Questionnaire (ACQ) Score - Adjusted
1 month follow up
|
0.7 score on a scale
Standard Error 0.3
|
1.3 score on a scale
Standard Error 0.3
|
|
Asthma Control Questionnaire (ACQ) Score - Adjusted
Baseline
|
1.4 score on a scale
Standard Error 0.2
|
1.5 score on a scale
Standard Error 0.2
|
|
Asthma Control Questionnaire (ACQ) Score - Adjusted
1 week follow up
|
0.9 score on a scale
Standard Error 0.4
|
1.1 score on a scale
Standard Error 0.4
|
SECONDARY outcome
Timeframe: 1 week follow up, 1 month follow upPopulation: data not available for participants with missing questionnaire
Treatment Credibility adjusted for age, sex, race, monthly income The credibility of a treatment rationale consists of "how believable, convincing, and logical the treatment is". The CEQ credibility factor, reflecting a cognitively-based process, is based on patients' summed responses to three items measuring how logical the therapy seems, how successful one thinks it will be in reducing symptoms, and how confident one would be in recommending it to a friend with similar symptoms. The modified version used in this study included items rated on 7 point scales ranging from 1 (Not at all logical/successful /confident) to 7 (Very logical/successful /confident), with a total score possible range of 3 to 21. Higher scores indicate higher treatment credibility.
Outcome measures
| Measure |
Asthma Education and PEF Feedback
n=28 Participants
Patients receive asthma education and personal Peak expiratory flow (PEF) feedback
PEF Feedback: Patients in the PEF feedback arm will receive a one-time session including asthma management education, discussion of their asthma symptoms, review of individual PEF results and perception of symptoms, and problem-solving techniques to improve asthma self-management. After the session, the participants in this arm will be able to view in the display of the AM2 device their PEF values and will be instructed to mentally note their actual results with their pre-effort estimated BPF. They will also set a motivational message for themselves that will appear on the device.
|
Asthma Education
n=25 Participants
No PEF feedback arm
Asthma education: General asthma education, AM2 training, and positive counseling, but no discussion linking asthma symptom perception to SMB. Following the session, these participants will use the AM2 to track PEF actual and perceived values twice per day, but they will be blinded to the actual PEF values. Control arm patients will see a standard motivational message appear on the screen of the AM2 device.
|
|---|---|---|
|
Treatment Credibility
1 week follow up
|
19.3 score on a scale
Standard Error 1.7
|
19.2 score on a scale
Standard Error 1.5
|
|
Treatment Credibility
1 month follow up
|
19.2 score on a scale
Standard Error 1.4
|
18.9 score on a scale
Standard Error 3.7
|
SECONDARY outcome
Timeframe: 1 week follow up, 1 month follow upPopulation: data not available for participants with missing questionnaire
Treatment Expectancy adjusted for age, sex, race, monthly income. Outcome expectancy consists of patients' beliefs about how likely they are to benefit from a treatment. The CEQ expectancy factor, reflecting an affectively-based process, is based on patients' responses to three items reflecting how much they think they will improve by the end of treatment, how much they feel therapy will help reduce their symptoms, and how much they feel they will improve by the end of treatment. Because one item is on the same 7-point scale as the credibility items and two are assessed on an 11-point scale (from 0% to 100% in 10-point increments), responses are first standardized before summing to render the expectancy total score. The total score possible range is 3 to 33. Higher scores indicate higher treatment expectancy.
Outcome measures
| Measure |
Asthma Education and PEF Feedback
n=28 Participants
Patients receive asthma education and personal Peak expiratory flow (PEF) feedback
PEF Feedback: Patients in the PEF feedback arm will receive a one-time session including asthma management education, discussion of their asthma symptoms, review of individual PEF results and perception of symptoms, and problem-solving techniques to improve asthma self-management. After the session, the participants in this arm will be able to view in the display of the AM2 device their PEF values and will be instructed to mentally note their actual results with their pre-effort estimated BPF. They will also set a motivational message for themselves that will appear on the device.
|
Asthma Education
n=25 Participants
No PEF feedback arm
Asthma education: General asthma education, AM2 training, and positive counseling, but no discussion linking asthma symptom perception to SMB. Following the session, these participants will use the AM2 to track PEF actual and perceived values twice per day, but they will be blinded to the actual PEF values. Control arm patients will see a standard motivational message appear on the screen of the AM2 device.
|
|---|---|---|
|
Treatment Expectancy
1 week follow up
|
25.3 score on a scale
Standard Error 4.6
|
25.2 score on a scale
Standard Error 2.7
|
|
Treatment Expectancy
1 month follow up
|
25.3 score on a scale
Standard Error 4.8
|
21.9 score on a scale
Standard Error 8.9
|
SECONDARY outcome
Timeframe: Baseline, 1 week follow up, 1 month follow upPopulation: data not available for participants with missing questionnaire
MARS is a self-reported questionnaire with the total score range from 0-10 with a higher score indicating better adherence. MARS, adjusted for age, sex, race, monthly income
Outcome measures
| Measure |
Asthma Education and PEF Feedback
n=28 Participants
Patients receive asthma education and personal Peak expiratory flow (PEF) feedback
PEF Feedback: Patients in the PEF feedback arm will receive a one-time session including asthma management education, discussion of their asthma symptoms, review of individual PEF results and perception of symptoms, and problem-solving techniques to improve asthma self-management. After the session, the participants in this arm will be able to view in the display of the AM2 device their PEF values and will be instructed to mentally note their actual results with their pre-effort estimated BPF. They will also set a motivational message for themselves that will appear on the device.
|
Asthma Education
n=25 Participants
No PEF feedback arm
Asthma education: General asthma education, AM2 training, and positive counseling, but no discussion linking asthma symptom perception to SMB. Following the session, these participants will use the AM2 to track PEF actual and perceived values twice per day, but they will be blinded to the actual PEF values. Control arm patients will see a standard motivational message appear on the screen of the AM2 device.
|
|---|---|---|
|
Change in Medication Adherence Rating Scale (MARS) Adjusted
Baseline
|
4.0 score on a scale
Standard Error 0.2
|
4.3 score on a scale
Standard Error 0.2
|
|
Change in Medication Adherence Rating Scale (MARS) Adjusted
1 week follow up
|
4.4 score on a scale
Standard Error 0.2
|
4.2 score on a scale
Standard Error 0.2
|
|
Change in Medication Adherence Rating Scale (MARS) Adjusted
1 month follow up
|
4.1 score on a scale
Standard Error 0.1
|
4.4 score on a scale
Standard Error 0.2
|
Adverse Events
Asthma Education and PEF Feedback
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Asthma Education
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