Trial Outcomes & Findings for Supporting Asthma Management Behaviors in Aging Adults (NCT NCT02316223)
NCT ID: NCT02316223
Last Updated: 2021-10-06
Results Overview
The Asthma Control Test™ is a quick test for people with asthma 12 years and older. The ACT is a 5 items, with 4-week recall (on symptoms and daily functioning) patient self-administered tool for identifying those with poorly controlled asthma. Each items is scored on a 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled), The total scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. It provides a numerical score to help assess asthma control at 12 months compared to baseline.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
406 participants
Primary outcome timeframe
baseline, 3 months, 6 months, and 12 months
Results posted on
2021-10-06
Participant Flow
Enrollment period from 2015 to 2017
Participant milestones
| Measure |
Clinic-based Care Coordination
Supporting Asthma Management Behaviors in Aging Adults (SAMBA): The SAMBA program will be led by an asthma care coach (ACC). The ACC will provide education, goal setting, and general self-management support with assigned patients and coordinate with PCPs through in-person and phone contacts over 12 months.
|
Home-based Care Coordination
Supporting Asthma Management Behaviors in Aging Adults (SAMBA): The SAMBA program will be led by an asthma care coach (ACC) and the home program by a community health worker (CHW). The ACC and CHW will provide education, goal setting, and general self-management support with assigned patients and coordinate with PCPs through in-person and phone contacts over 12 months.
|
Usual Care
Clinician-centric strategy and EMR-based clinician decision support
|
|---|---|---|---|
|
Overall Study
STARTED
|
134
|
133
|
139
|
|
Overall Study
COMPLETED
|
90
|
76
|
95
|
|
Overall Study
NOT COMPLETED
|
44
|
57
|
44
|
Reasons for withdrawal
| Measure |
Clinic-based Care Coordination
Supporting Asthma Management Behaviors in Aging Adults (SAMBA): The SAMBA program will be led by an asthma care coach (ACC). The ACC will provide education, goal setting, and general self-management support with assigned patients and coordinate with PCPs through in-person and phone contacts over 12 months.
|
Home-based Care Coordination
Supporting Asthma Management Behaviors in Aging Adults (SAMBA): The SAMBA program will be led by an asthma care coach (ACC) and the home program by a community health worker (CHW). The ACC and CHW will provide education, goal setting, and general self-management support with assigned patients and coordinate with PCPs through in-person and phone contacts over 12 months.
|
Usual Care
Clinician-centric strategy and EMR-based clinician decision support
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
27
|
34
|
36
|
|
Overall Study
COPD Diagnosis
|
3
|
2
|
3
|
|
Overall Study
Reside outside study area
|
1
|
1
|
1
|
|
Overall Study
No asthma
|
2
|
0
|
0
|
|
Overall Study
Discontinued by PI
|
11
|
19
|
3
|
Baseline Characteristics
Supporting Asthma Management Behaviors in Aging Adults
Baseline characteristics by cohort
| Measure |
Usual Care
n=134 Participants
Clinician-centric strategy and EMR-based clinician decision support
|
Home-based Care Coordination
n=128 Participants
Supporting Asthma Management Behaviors in Aging Adults (SAMBA): The SAMBA program will be led by an asthma care coach (ACC) and the home program by a community health worker (CHW). The CHW will provide education, goal setting, and general self-management support with assigned patients and coordinate with PCPs through in-person and phone contacts over 12 months.
|
Clinic-based Care Coordination
n=129 Participants
Supporting Asthma Management Behaviors in Aging Adults (SAMBA): The SAMBA program will be led by an asthma care coach (ACC). The ACC will provide education, goal setting, and general self-management support with assigned patients and coordinate with PCPs through in-person and phone contacts over 12 months.
|
Total
n=391 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
80+
|
19 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
117 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
333 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black, non-Hispanic
|
43 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
119 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
76 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
220 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Limited English Proficiency
|
52 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
144 Participants
n=4 Participants
|
|
Monthly Household Income <$1350
|
86 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
262 Participants
n=4 Participants
|
|
Married or Partner
|
39 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
|
Education Level
Less than high school
|
63 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
163 Participants
n=4 Participants
|
|
Education Level
High school graduate
|
27 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Education Level
Some college
|
31 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
|
Education Level
College graduate
|
13 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Physical Impairment, severe
|
22 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Cognitive Impairment
|
75 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
204 Participants
n=4 Participants
|
|
Moderate-severed Depression
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Diabetes Mellitus Co-morbid Medical Condition
|
52 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
153 Participants
n=4 Participants
|
|
High Cholesterol Co-morbid Medical Condition
|
74 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
210 Participants
n=4 Participants
|
|
Hypertension Co-morbid Medical Condition
|
106 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
283 Participants
n=4 Participants
|
|
Age, Continuous
|
68.4 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
67.8 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
66.5 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
67.3 years
STANDARD_DEVIATION 7.0 • n=4 Participants
|
|
Age, Customized
60-69
|
88 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
270 Participants
n=4 Participants
|
|
Age, Customized
70-79
|
27 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline, 3 months, 6 months, and 12 monthsPopulation: only those who completed the respective study visits were included in the data results
The Asthma Control Test™ is a quick test for people with asthma 12 years and older. The ACT is a 5 items, with 4-week recall (on symptoms and daily functioning) patient self-administered tool for identifying those with poorly controlled asthma. Each items is scored on a 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled), The total scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. It provides a numerical score to help assess asthma control at 12 months compared to baseline.
Outcome measures
| Measure |
Home-based Care Coordination
n=128 Participants
Supporting Asthma Management Behaviors in Aging Adults (SAMBA): The SAMBA program will be led by an asthma care coach (ACC) and the home program by a community health worker (CHW). The CHW will provide education, goal setting, and general self-management support with assigned patients and coordinate with PCPs through in-person and phone contacts over 12 months.
|
Clinic-based Care Coordination
n=129 Participants
Supporting Asthma Management Behaviors in Aging Adults (SAMBA): The SAMBA program will be led by an asthma care coach (ACC). The ACC will provide education, goal setting, and general self-management support with assigned patients and coordinate with PCPs through in-person and phone contacts over 12 months.
|
Usual Care
n=134 Participants
Clinician-centric strategy and EMR-based clinician decision support
|
|---|---|---|---|
|
Change in Asthma Control Test (ACT)
Baseline
|
15.0 score on a scale
Standard Deviation 3.8
|
14.6 score on a scale
Standard Deviation 4.0
|
14.3 score on a scale
Standard Deviation 4.0
|
|
Change in Asthma Control Test (ACT)
3 months
|
16.6 score on a scale
Standard Deviation 4.4
|
15.7 score on a scale
Standard Deviation 4.4
|
14.6 score on a scale
Standard Deviation 4.8
|
|
Change in Asthma Control Test (ACT)
6 months
|
16.8 score on a scale
Standard Deviation 4.3
|
15.8 score on a scale
Standard Deviation 4.4
|
14.6 score on a scale
Standard Deviation 4.9
|
|
Change in Asthma Control Test (ACT)
12 months
|
17.4 score on a scale
Standard Deviation 4.8
|
16.9 score on a scale
Standard Deviation 4.7
|
16.1 score on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: baseline, 3 months, 6 months, and 12 monthsPopulation: only those who completed the respective study visits were included in the data results
The mini AQLQ is a 15-item self-administered questionnaire, each question scored on a 7-point scale, from 1 (all of the time) to 7 (none of the time) for the first 11 questions, and 1 (totally limited) to 7 (not at all limited) for the last 4 question , with total scale as an average from 1 to 7, with higher score indicating better quality of life or less impairment.
Outcome measures
| Measure |
Home-based Care Coordination
n=128 Participants
Supporting Asthma Management Behaviors in Aging Adults (SAMBA): The SAMBA program will be led by an asthma care coach (ACC) and the home program by a community health worker (CHW). The CHW will provide education, goal setting, and general self-management support with assigned patients and coordinate with PCPs through in-person and phone contacts over 12 months.
|
Clinic-based Care Coordination
n=129 Participants
Supporting Asthma Management Behaviors in Aging Adults (SAMBA): The SAMBA program will be led by an asthma care coach (ACC). The ACC will provide education, goal setting, and general self-management support with assigned patients and coordinate with PCPs through in-person and phone contacts over 12 months.
|
Usual Care
n=134 Participants
Clinician-centric strategy and EMR-based clinician decision support
|
|---|---|---|---|
|
Mini Asthma Quality of Life Questionnaire (AQLQ)
Baseline
|
4.4 score on a scale
Standard Deviation 1.2
|
4.4 score on a scale
Standard Deviation 1.2
|
4.3 score on a scale
Standard Deviation 1.1
|
|
Mini Asthma Quality of Life Questionnaire (AQLQ)
3 months
|
4.8 score on a scale
Standard Deviation 1.8
|
4.6 score on a scale
Standard Deviation 1.2
|
4.3 score on a scale
Standard Deviation 1.3
|
|
Mini Asthma Quality of Life Questionnaire (AQLQ)
6 months
|
4.9 score on a scale
Standard Deviation 1.2
|
4.5 score on a scale
Standard Deviation 1.4
|
4.3 score on a scale
Standard Deviation 1.3
|
|
Mini Asthma Quality of Life Questionnaire (AQLQ)
12 months
|
4.9 score on a scale
Standard Deviation 1.3
|
4.8 score on a scale
Standard Deviation 1.4
|
4.6 score on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: only those who completed the study at 12 months were included for the data results for the 12 month mark
Percent of patients with one or more acute asthma-related Emergency Department visits at 12 months compared to baseline for participants in Home-based care coordination and Clinic-based care coordination.
Outcome measures
| Measure |
Home-based Care Coordination
n=128 Participants
Supporting Asthma Management Behaviors in Aging Adults (SAMBA): The SAMBA program will be led by an asthma care coach (ACC) and the home program by a community health worker (CHW). The CHW will provide education, goal setting, and general self-management support with assigned patients and coordinate with PCPs through in-person and phone contacts over 12 months.
|
Clinic-based Care Coordination
n=129 Participants
Supporting Asthma Management Behaviors in Aging Adults (SAMBA): The SAMBA program will be led by an asthma care coach (ACC). The ACC will provide education, goal setting, and general self-management support with assigned patients and coordinate with PCPs through in-person and phone contacts over 12 months.
|
Usual Care
n=134 Participants
Clinician-centric strategy and EMR-based clinician decision support
|
|---|---|---|---|
|
Change in Percent of Patients With >=1 Emergency Dept Visits
Baseline
|
13.1 percentage of participants
|
9.3 percentage of participants
|
9.7 percentage of participants
|
|
Change in Percent of Patients With >=1 Emergency Dept Visits
12 months
|
7.7 percentage of participants
|
6.2 percentage of participants
|
12.7 percentage of participants
|
SECONDARY outcome
Timeframe: baseline, 3 months, 6 months, and 12 monthsPopulation: only those who completed the respective study visits were included in the data results
Adherence to ICS and leukotriene receptor antagonists will be assessed with the MARS, a 10-item self-reported measure of adherence to inhaler medications at 12 months compared to baseline. Total scores range from 0 (low likelihood of medication adherence) to 10 (high likelihood), with higher score indicating higher likelihood of medication adherence
Outcome measures
| Measure |
Home-based Care Coordination
n=128 Participants
Supporting Asthma Management Behaviors in Aging Adults (SAMBA): The SAMBA program will be led by an asthma care coach (ACC) and the home program by a community health worker (CHW). The CHW will provide education, goal setting, and general self-management support with assigned patients and coordinate with PCPs through in-person and phone contacts over 12 months.
|
Clinic-based Care Coordination
n=129 Participants
Supporting Asthma Management Behaviors in Aging Adults (SAMBA): The SAMBA program will be led by an asthma care coach (ACC). The ACC will provide education, goal setting, and general self-management support with assigned patients and coordinate with PCPs through in-person and phone contacts over 12 months.
|
Usual Care
n=134 Participants
Clinician-centric strategy and EMR-based clinician decision support
|
|---|---|---|---|
|
Medication Adherence Rating Scale (MARS)
Baseline
|
3.6 score on a scale
Standard Deviation 0.7
|
3.7 score on a scale
Standard Deviation 0.6
|
3.8 score on a scale
Standard Deviation 0.7
|
|
Medication Adherence Rating Scale (MARS)
3 months
|
3.9 score on a scale
Standard Deviation 0.6
|
3.9 score on a scale
Standard Deviation 0.6
|
3.8 score on a scale
Standard Deviation 0.7
|
|
Medication Adherence Rating Scale (MARS)
6 months
|
3.9 score on a scale
Standard Deviation 0.7
|
4.0 score on a scale
Standard Deviation 0.7
|
3.8 score on a scale
Standard Deviation 0.7
|
|
Medication Adherence Rating Scale (MARS)
12 months
|
3.8 score on a scale
Standard Deviation 0.8
|
4.0 score on a scale
Standard Deviation 0.7
|
3.8 score on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: baseline and 12 monthsPopulation: only those who completed the study at 12 months were included for the data results for the 12 month mark
Number of participants demonstrating MDI technique, correctly completed steps at 12 months as compared to baseline
Outcome measures
| Measure |
Home-based Care Coordination
n=128 Participants
Supporting Asthma Management Behaviors in Aging Adults (SAMBA): The SAMBA program will be led by an asthma care coach (ACC) and the home program by a community health worker (CHW). The CHW will provide education, goal setting, and general self-management support with assigned patients and coordinate with PCPs through in-person and phone contacts over 12 months.
|
Clinic-based Care Coordination
n=129 Participants
Supporting Asthma Management Behaviors in Aging Adults (SAMBA): The SAMBA program will be led by an asthma care coach (ACC). The ACC will provide education, goal setting, and general self-management support with assigned patients and coordinate with PCPs through in-person and phone contacts over 12 months.
|
Usual Care
n=134 Participants
Clinician-centric strategy and EMR-based clinician decision support
|
|---|---|---|---|
|
Number of Participants With Correct MDI Technique
Baseline
|
77 Participants
|
71 Participants
|
86 Participants
|
|
Number of Participants With Correct MDI Technique
12 months
|
54 Participants
|
55 Participants
|
55 Participants
|
Adverse Events
Home-based Care Coordination
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clinic-based Care Coordination
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
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
Dr. Alex Federman
Icahn School of Medicine at Mount Sinai
Phone: 212-824-7565
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place