Trial Outcomes & Findings for The Houston HIITBAC for African Americans (NCT NCT02253433)
NCT ID: NCT02253433
Last Updated: 2018-11-14
Results Overview
Self report. The ACT is a validated 5-question scale assessing asthma control over the previous four weeks. Each question has five possible responses, from 1 (worst) to 5 (best). The total score ranges from 5 (worst control) to 25 (best control). In general, a total score of 19 or less suggests poor control.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
264 participants
Primary outcome timeframe
At baseline (enrollment) and exit (approximately 12 mo after enrollment)
Results posted on
2018-11-14
Participant Flow
Participant milestones
| Measure |
Enhanced Clinic Care
This arm will receive enhanced in-clinic care that includes a standard clinical appointment as well as information from a detailed exposure history, asthma education, assessment for allergies, and a customized asthma self-management plan developed using motivational interviewing.
|
Enhanced Clinic Care + Home Intervention
This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).
Enhanced in-clinic care and intervention: This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).
|
|---|---|---|
|
Overall Study
STARTED
|
130
|
134
|
|
Overall Study
COMPLETED
|
114
|
79
|
|
Overall Study
NOT COMPLETED
|
16
|
55
|
Reasons for withdrawal
| Measure |
Enhanced Clinic Care
This arm will receive enhanced in-clinic care that includes a standard clinical appointment as well as information from a detailed exposure history, asthma education, assessment for allergies, and a customized asthma self-management plan developed using motivational interviewing.
|
Enhanced Clinic Care + Home Intervention
This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).
Enhanced in-clinic care and intervention: This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).
|
|---|---|---|
|
Overall Study
Unable to Contact
|
9
|
16
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
No Longer Interested
|
3
|
15
|
|
Overall Study
Out of Study Area
|
2
|
7
|
|
Overall Study
Uncomfortable with home visitors
|
0
|
3
|
|
Overall Study
Unstable Housing/Homeless
|
0
|
7
|
|
Overall Study
Too Busy
|
0
|
4
|
|
Overall Study
Medical or Other Concerns
|
1
|
2
|
Baseline Characteristics
One participant consented and withdrew before any baseline characteristics (aside from age, gender and race) were collected. A second participant chose not to answer all five questions.
Baseline characteristics by cohort
| Measure |
Enhanced Clinic Care
n=130 Participants
This arm will receive enhanced in-clinic care that includes a standard clinical appointment as well as information from a detailed exposure history, asthma education, assessment for allergies, and a customized asthma self-management plan developed using motivational interviewing.
|
Enhanced Clinic Care + Home Intervention
n=134 Participants
This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).
Enhanced in-clinic care and intervention: This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).
|
Total
n=264 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=130 Participants
|
0 Participants
n=134 Participants
|
0 Participants
n=264 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
117 Participants
n=130 Participants
|
118 Participants
n=134 Participants
|
235 Participants
n=264 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=130 Participants
|
16 Participants
n=134 Participants
|
29 Participants
n=264 Participants
|
|
Age, Continuous
|
49.4 years
STANDARD_DEVIATION 12.7 • n=130 Participants
|
51.0 years
STANDARD_DEVIATION 13.3 • n=134 Participants
|
50.2 years
STANDARD_DEVIATION 13.0 • n=264 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=130 Participants
|
98 Participants
n=134 Participants
|
196 Participants
n=264 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=130 Participants
|
36 Participants
n=134 Participants
|
68 Participants
n=264 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=130 Participants
|
0 Participants
n=134 Participants
|
0 Participants
n=264 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=130 Participants
|
0 Participants
n=134 Participants
|
0 Participants
n=264 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=130 Participants
|
0 Participants
n=134 Participants
|
0 Participants
n=264 Participants
|
|
Race (NIH/OMB)
Black or African American
|
130 Participants
n=130 Participants
|
134 Participants
n=134 Participants
|
264 Participants
n=264 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=130 Participants
|
0 Participants
n=134 Participants
|
0 Participants
n=264 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=130 Participants
|
0 Participants
n=134 Participants
|
0 Participants
n=264 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=130 Participants
|
0 Participants
n=134 Participants
|
0 Participants
n=264 Participants
|
|
Region of Enrollment
United States
|
130 participants
n=130 Participants
|
134 participants
n=134 Participants
|
264 participants
n=264 Participants
|
|
Asthma Control Test (ACT)
|
12.5 units on a scale
STANDARD_DEVIATION 4.3 • n=129 Participants • One participant consented and withdrew before any baseline characteristics (aside from age, gender and race) were collected. A second participant chose not to answer all five questions.
|
12.5 units on a scale
STANDARD_DEVIATION 4.2 • n=133 Participants • One participant consented and withdrew before any baseline characteristics (aside from age, gender and race) were collected. A second participant chose not to answer all five questions.
|
12.5 units on a scale
STANDARD_DEVIATION 4.3 • n=262 Participants • One participant consented and withdrew before any baseline characteristics (aside from age, gender and race) were collected. A second participant chose not to answer all five questions.
|
|
Juniper Mini Asthma Quality of Life Questionnaire
|
3.3 units on a scale
STANDARD_DEVIATION 1.2 • n=127 Participants • In the enhanced clinical care ("control") group, one person withdrew immediately after consent, and two individuals chose not to answer one of the 15 questions. In the home-visit ("intervention") group, three individuals chose not to answer one question. Interpolation (inserted worst answer) was used in some of the analyses.
|
3.2 units on a scale
STANDARD_DEVIATION 1.1 • n=131 Participants • In the enhanced clinical care ("control") group, one person withdrew immediately after consent, and two individuals chose not to answer one of the 15 questions. In the home-visit ("intervention") group, three individuals chose not to answer one question. Interpolation (inserted worst answer) was used in some of the analyses.
|
3.2 units on a scale
STANDARD_DEVIATION 1.1 • n=258 Participants • In the enhanced clinical care ("control") group, one person withdrew immediately after consent, and two individuals chose not to answer one of the 15 questions. In the home-visit ("intervention") group, three individuals chose not to answer one question. Interpolation (inserted worst answer) was used in some of the analyses.
|
|
Body Mass Index (BMI)
|
36.0 kg/m^2
STANDARD_DEVIATION 10.6 • n=129 Participants • One person withdrew immediately after consent.
|
34.4 kg/m^2
STANDARD_DEVIATION 10.1 • n=134 Participants • One person withdrew immediately after consent.
|
35.2 kg/m^2
STANDARD_DEVIATION 10.4 • n=263 Participants • One person withdrew immediately after consent.
|
|
Total Immunoglobulin E (Total IgE)
|
550.5 kU/L
STANDARD_DEVIATION 1479.8 • n=127 Participants • One participant withdrew immediately after consent, permission for a blood draw was not given by two patients, and blood could not be obtained or was insufficient for analysis in four patients.
|
643.2 kU/L
STANDARD_DEVIATION 1217.6 • n=131 Participants • One participant withdrew immediately after consent, permission for a blood draw was not given by two patients, and blood could not be obtained or was insufficient for analysis in four patients.
|
597.6 kU/L
STANDARD_DEVIATION 1351.2 • n=258 Participants • One participant withdrew immediately after consent, permission for a blood draw was not given by two patients, and blood could not be obtained or was insufficient for analysis in four patients.
|
PRIMARY outcome
Timeframe: At baseline (enrollment) and exit (approximately 12 mo after enrollment)Population: At baseline, one individual in each group chose not to answer all five ACT questions; therefore a total ACT score could not be calculated for those two individuals (missing data are addressed in the analyses). At exit, among those who completed the study, one person in the enhanced in-clinic group chose not to answer all five ACT questions.
Self report. The ACT is a validated 5-question scale assessing asthma control over the previous four weeks. Each question has five possible responses, from 1 (worst) to 5 (best). The total score ranges from 5 (worst control) to 25 (best control). In general, a total score of 19 or less suggests poor control.
Outcome measures
| Measure |
Enhanced Clinic Care
n=130 Participants
This arm will receive enhanced in-clinic care that includes a standard clinical appointment as well as information from a detailed exposure history, asthma education, assessment for allergies, and a customized asthma self-management plan developed using motivational interviewing.
|
Enhanced Clinic Care + Home Intervention
n=134 Participants
This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).
Enhanced in-clinic care and intervention: This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).
|
|---|---|---|
|
Change in Asthma Control Test (ACT) Score
Baseline
|
12.5 score on a scale
Standard Deviation 4.3
|
12.5 score on a scale
Standard Deviation 4.2
|
|
Change in Asthma Control Test (ACT) Score
Exit
|
16.2 score on a scale
Standard Deviation 5.1
|
16.8 score on a scale
Standard Deviation 5.1
|
PRIMARY outcome
Timeframe: At baseline (enrollment) and exit (approximately 12 mo after enrollment)Population: Among the enhanced in-clinic care group, one person withdrew immediately after consent and two individuals chose not to fill out all of the answers, such that a score could not be computer. At exit, 3 control and 1 intervention were missing (1) or incomplete (3).
Self report. A validated 15-item questionnaire, with each question having seven possible answers score from 1 (worst) to 7 (best). Minimum total score is 15 (worst asthma quality of life). Maximum total score is 105 (best asthma quality of life). By design, an individual's score is reported as the mean (total score/15). Thus the possible mean reported score ranges from 1 (worst asthma quality of life) to 7 (best asthma quality of life).
Outcome measures
| Measure |
Enhanced Clinic Care
n=127 Participants
This arm will receive enhanced in-clinic care that includes a standard clinical appointment as well as information from a detailed exposure history, asthma education, assessment for allergies, and a customized asthma self-management plan developed using motivational interviewing.
|
Enhanced Clinic Care + Home Intervention
n=134 Participants
This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).
Enhanced in-clinic care and intervention: This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).
|
|---|---|---|
|
Change in Juniper Mini Asthma Quality of Life Questionnaire Score (MiniAQLQ)
Exit
|
4.3 score on a scale
Standard Deviation 1.5
|
4.5 score on a scale
Standard Deviation 1.5
|
|
Change in Juniper Mini Asthma Quality of Life Questionnaire Score (MiniAQLQ)
Baseline
|
3.3 score on a scale
Standard Deviation 1.2
|
3.2 score on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: At baseline (enrollment) and exit (approximately 12 mo after enrollment)Population: One patient from the enhanced in-clinic only group withdrew immediately after consenting.114 "control" and 79 "intervention" completed the study. Respondent number less than enrollment and/or exit numbers reflects individuals who chose not to respond to the question.
Self report. The healthcare utilization questions were from the validated CDC-BRFSS Asthma Survey. For this outcome measure, we used patient responses to a question that asked "During the past 12 months, how many times to you visit an emergency room of urgent care center because of your asthma?". We collected this information for the 12 months preceding their baseline and exit clinic visits. A higher number of visits suggests poorer asthma control.
Outcome measures
| Measure |
Enhanced Clinic Care
n=130 Participants
This arm will receive enhanced in-clinic care that includes a standard clinical appointment as well as information from a detailed exposure history, asthma education, assessment for allergies, and a customized asthma self-management plan developed using motivational interviewing.
|
Enhanced Clinic Care + Home Intervention
n=134 Participants
This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).
Enhanced in-clinic care and intervention: This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).
|
|---|---|---|
|
Change in Emergency Department (ED) Visits for Asthma
Baseline
|
2.2 visits
Standard Deviation 3.5
|
2.6 visits
Standard Deviation 3.5
|
|
Change in Emergency Department (ED) Visits for Asthma
Exit
|
1.3 visits
Standard Deviation 2.4
|
1.1 visits
Standard Deviation 2.0
|
Adverse Events
Enhanced Clinic Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Enhanced Clinic Care + Home Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Winifred J. Hamilton
Environmental Health, Baylor College of Medicine
Phone: 713-798-1052
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place