Trial Outcomes & Findings for Using IT to Improve Access, Communication and Asthma in African American and Hispanic/Latino Adults (NCT NCT02086565)
NCT ID: NCT02086565
Last Updated: 2019-06-19
Results Overview
This is a validated test with 6 items each with Likert score 0 to 6, reflecting symptoms over the past week. Lower score is a better outcome. We measured change in Asthma Control Questionnaire score from baseline to at least 12 months.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
301 participants
Primary outcome timeframe
baseline and over a year
Results posted on
2019-06-19
Participant Flow
We intended to enroll 300 participants. Because several research coordinators were working at once, and calls were pending to patients, we identified and enrolled and randomized 301 participants..
Participant milestones
| Measure |
Portal Training and Home Visits
Portal training and home visits from a community health worker to promote care coordination and use of the patient portal
Portal training and home visits: patient portal training and home visits by CHW to coordinate care
|
Portal Training
Participants are assured internet access and taught to use the patient portal
Portal training: training in use of patient portal
|
|---|---|---|
|
Overall Study
STARTED
|
151
|
150
|
|
Overall Study
COMPLETED
|
135
|
138
|
|
Overall Study
NOT COMPLETED
|
16
|
12
|
Reasons for withdrawal
| Measure |
Portal Training and Home Visits
Portal training and home visits from a community health worker to promote care coordination and use of the patient portal
Portal training and home visits: patient portal training and home visits by CHW to coordinate care
|
Portal Training
Participants are assured internet access and taught to use the patient portal
Portal training: training in use of patient portal
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
7
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Death
|
3
|
2
|
|
Overall Study
withdrawn by research team
|
2
|
2
|
Baseline Characteristics
Using IT to Improve Access, Communication and Asthma in African American and Hispanic/Latino Adults
Baseline characteristics by cohort
| Measure |
Portal Training and Home Visits
n=151 Participants
Portal training and home visits from a community health worker to promote care coordination and use of the patient portal
Portal training and home visits: patient portal training and home visits by CHW to coordinate care
|
Portal Training
n=150 Participants
Participants are assured internet access and taught to use the patient portal
Portal training: training in use of patient portal
|
Total
n=301 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 14 • n=5 Participants
|
48 years
STANDARD_DEVIATION 12 • n=7 Participants
|
49 years
STANDARD_DEVIATION 15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
136 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
270 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
117 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
231 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
116 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
229 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
22 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
asthma control questionnaire
|
2.4 units on a scale
STANDARD_DEVIATION 1.1 • n=5 Participants
|
2.4 units on a scale
STANDARD_DEVIATION 1.2 • n=7 Participants
|
2.4 units on a scale
STANDARD_DEVIATION 1.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and over a yearPopulation: The result is the mean change in asthma control (lower is improved control) at 12 months from baseline.
This is a validated test with 6 items each with Likert score 0 to 6, reflecting symptoms over the past week. Lower score is a better outcome. We measured change in Asthma Control Questionnaire score from baseline to at least 12 months.
Outcome measures
| Measure |
Portal Training and Home Visits
n=151 Participants
Portal training and home visits from a community health worker to promote care coordination and use of the patient portal
Portal training and home visits: patient portal training and home visits by CHW to coordinate care
|
Portal Training
n=150 Participants
Participants are assured internet access and taught to use the patient portal
Portal training: training in use of patient portal
|
|---|---|---|
|
Score of Asthma Control Questionnaire
|
-0.48 score on a scale
Interval -0.76 to -0.22
|
-0.27 score on a scale
Interval -0.52 to -0.01
|
SECONDARY outcome
Timeframe: baseline and over a yearPopulation: Quality of life is a 15-item questionnaire with 7 point response scale (1-7), higher score is better quality of life. Here we measure change in quality of life over time in the study.
Quality of life is a 15-item questionnaire with 7 point response scale (1-7), higher score is better quality of life. We measured the change from baseline and over a year.
Outcome measures
| Measure |
Portal Training and Home Visits
n=151 Participants
Portal training and home visits from a community health worker to promote care coordination and use of the patient portal
Portal training and home visits: patient portal training and home visits by CHW to coordinate care
|
Portal Training
n=150 Participants
Participants are assured internet access and taught to use the patient portal
Portal training: training in use of patient portal
|
|---|---|---|
|
Asthma-related Quality of Life
|
0.64 score on a scale
Interval 0.31 to 0.98
|
0.45 score on a scale
Interval 0.13 to 0.78
|
SECONDARY outcome
Timeframe: one year before baseline to one year after baselinePopulation: ED visits per year over period of participation
Emergency department visits for asthma from one year before baseline to one year after baseline.
Outcome measures
| Measure |
Portal Training and Home Visits
n=151 Participants
Portal training and home visits from a community health worker to promote care coordination and use of the patient portal
Portal training and home visits: patient portal training and home visits by CHW to coordinate care
|
Portal Training
n=150 Participants
Participants are assured internet access and taught to use the patient portal
Portal training: training in use of patient portal
|
|---|---|---|
|
Emergency Department Visits
|
-3.29 ED visits per year
Interval -4.73 to -2.1
|
-2.69 ED visits per year
Interval -3.67 to -1.88
|
SECONDARY outcome
Timeframe: Hospitalizations for asthma in the year before baseline to one year after baselinePopulation: rate per year
Hospitalizations for asthma in the year before baseline to one year after baseline.
Outcome measures
| Measure |
Portal Training and Home Visits
n=151 Participants
Portal training and home visits from a community health worker to promote care coordination and use of the patient portal
Portal training and home visits: patient portal training and home visits by CHW to coordinate care
|
Portal Training
n=150 Participants
Participants are assured internet access and taught to use the patient portal
Portal training: training in use of patient portal
|
|---|---|---|
|
Hospitalizations
|
-1.19 hospitalizations per year
Interval -1.56 to -0.8
|
-0.66 hospitalizations per year
Interval -1.02 to -0.3
|
SECONDARY outcome
Timeframe: bursts at baseline and at one yearPopulation: new prescriptions of prednisone or increases in an already-prescribed dose ("bursts") per year for an asthma exacerbation
new prescriptions of prednisone or increases in an already-prescribed dose for an asthma exacerbation measured at baseline and at one year.
Outcome measures
| Measure |
Portal Training and Home Visits
n=151 Participants
Portal training and home visits from a community health worker to promote care coordination and use of the patient portal
Portal training and home visits: patient portal training and home visits by CHW to coordinate care
|
Portal Training
n=150 Participants
Participants are assured internet access and taught to use the patient portal
Portal training: training in use of patient portal
|
|---|---|---|
|
Prednisone Bursts
|
-0.21 bursts per year
Interval -0.32 to -0.09
|
-0.12 bursts per year
Interval -0.21 to -0.02
|
Adverse Events
Portal Training and Home Visits
Serious events: 49 serious events
Other events: 14 other events
Deaths: 3 deaths
Portal Training
Serious events: 63 serious events
Other events: 18 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Portal Training and Home Visits
n=151 participants at risk
Portal training and home visits from a community health worker to promote care coordination and use of the patient portal
Portal training and home visits: patient portal training and home visits by CHW to coordinate care
|
Portal Training
n=150 participants at risk
Participants are assured internet access and taught to use the patient portal
Portal training: training in use of patient portal
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
bronchospasm
|
26.5%
40/151 • One year
Not different.
|
28.0%
42/150 • One year
Not different.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.3%
2/151 • One year
Not different.
|
2.7%
4/150 • One year
Not different.
|
|
Cardiac disorders
chest pain
|
0.66%
1/151 • One year
Not different.
|
2.0%
3/150 • One year
Not different.
|
|
Immune system disorders
allergic reaction
|
1.3%
2/151 • One year
Not different.
|
0.67%
1/150 • One year
Not different.
|
|
Injury, poisoning and procedural complications
Fall
|
1.3%
2/151 • One year
Not different.
|
0.67%
1/150 • One year
Not different.
|
|
Cardiac disorders
hypertension
|
0.00%
0/151 • One year
Not different.
|
2.7%
4/150 • One year
Not different.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
0.66%
1/151 • One year
Not different.
|
0.67%
1/150 • One year
Not different.
|
|
Nervous system disorders
headache
|
0.00%
0/151 • One year
Not different.
|
1.3%
2/150 • One year
Not different.
|
|
Injury, poisoning and procedural complications
injury, poisoning and procedural complications
|
0.00%
0/151 • One year
Not different.
|
2.0%
3/150 • One year
Not different.
|
|
Respiratory, thoracic and mediastinal disorders
bronchial infection
|
0.00%
0/151 • One year
Not different.
|
1.3%
2/150 • One year
Not different.
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/151 • One year
Not different.
|
0.67%
1/150 • One year
Not different.
|
|
Gastrointestinal disorders
GI reflux
|
0.00%
0/151 • One year
Not different.
|
0.67%
1/150 • One year
Not different.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.66%
1/151 • One year
Not different.
|
0.67%
1/150 • One year
Not different.
|
|
Cardiac disorders
chest wall pain
|
0.66%
1/151 • One year
Not different.
|
0.67%
1/150 • One year
Not different.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.66%
1/151 • One year
Not different.
|
0.67%
1/150 • One year
Not different.
|
|
General disorders
pain
|
0.00%
0/151 • One year
Not different.
|
1.3%
2/150 • One year
Not different.
|
|
Immune system disorders
anaphlaxis
|
0.00%
0/151 • One year
Not different.
|
0.67%
1/150 • One year
Not different.
|
|
Cardiac disorders
heart attack, myocardial infarction
|
0.66%
1/151 • One year
Not different.
|
0.67%
1/150 • One year
Not different.
|
|
Cardiac disorders
cardiac disorder
|
0.00%
0/151 • One year
Not different.
|
0.67%
1/150 • One year
Not different.
|
|
Gastrointestinal disorders
colitis
|
0.00%
0/151 • One year
Not different.
|
0.67%
1/150 • One year
Not different.
|
|
Cardiac disorders
heart failure
|
0.66%
1/151 • One year
Not different.
|
0.00%
0/150 • One year
Not different.
|
|
Endocrine disorders
hyperglycemia
|
0.00%
0/151 • One year
Not different.
|
0.67%
1/150 • One year
Not different.
|
|
Immune system disorders
immune system disorder- Graves disease
|
0.00%
0/151 • One year
Not different.
|
0.67%
1/150 • One year
Not different.
|
|
Gastrointestinal disorders
oral pain
|
0.00%
0/151 • One year
Not different.
|
0.67%
1/150 • One year
Not different.
|
|
Cardiac disorders
palpitations
|
0.66%
1/151 • One year
Not different.
|
0.00%
0/150 • One year
Not different.
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
0.66%
1/151 • One year
Not different.
|
0.00%
0/150 • One year
Not different.
|
|
Nervous system disorders
Seizures
|
0.00%
0/151 • One year
Not different.
|
0.67%
1/150 • One year
Not different.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/151 • One year
Not different.
|
0.67%
1/150 • One year
Not different.
|
|
Infections and infestations
sinusitis
|
0.66%
1/151 • One year
Not different.
|
0.00%
0/150 • One year
Not different.
|
|
Infections and infestations
upper respiratory infection
|
0.00%
0/151 • One year
Not different.
|
0.67%
1/150 • One year
Not different.
|
|
Skin and subcutaneous tissue disorders
urticaria
|
0.00%
0/151 • One year
Not different.
|
0.67%
1/150 • One year
Not different.
|
|
Infections and infestations
penile infection
|
0.00%
0/151 • One year
Not different.
|
0.67%
1/150 • One year
Not different.
|
|
Nervous system disorders
stroke
|
1.3%
2/151 • One year
Not different.
|
0.67%
1/150 • One year
Not different.
|
|
Psychiatric disorders
anxiety
|
0.66%
1/151 • One year
Not different.
|
0.00%
0/150 • One year
Not different.
|
|
General disorders
flu like symptoms
|
0.66%
1/151 • One year
Not different.
|
0.00%
0/150 • One year
Not different.
|
Other adverse events
| Measure |
Portal Training and Home Visits
n=151 participants at risk
Portal training and home visits from a community health worker to promote care coordination and use of the patient portal
Portal training and home visits: patient portal training and home visits by CHW to coordinate care
|
Portal Training
n=150 participants at risk
Participants are assured internet access and taught to use the patient portal
Portal training: training in use of patient portal
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
7.3%
11/151 • One year
Not different.
|
10.0%
15/150 • One year
Not different.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.66%
1/151 • One year
Not different.
|
0.67%
1/150 • One year
Not different.
|
|
Respiratory, thoracic and mediastinal disorders
wheeze
|
0.66%
1/151 • One year
Not different.
|
0.67%
1/150 • One year
Not different.
|
|
Infections and infestations
bronchial infection
|
0.66%
1/151 • One year
Not different.
|
0.67%
1/150 • One year
Not different.
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/151 • One year
Not different.
|
0.67%
1/150 • One year
Not different.
|
|
Gastrointestinal disorders
acid reflux
|
0.00%
0/151 • One year
Not different.
|
0.67%
1/150 • One year
Not different.
|
|
Respiratory, thoracic and mediastinal disorders
allergic rhinitis
|
0.66%
1/151 • One year
Not different.
|
0.00%
0/150 • One year
Not different.
|
|
Cardiac disorders
chest pain
|
0.66%
1/151 • One year
Not different.
|
0.00%
0/150 • One year
Not different.
|
|
Eye disorders
dry eye
|
0.66%
1/151 • One year
Not different.
|
0.00%
0/150 • One year
Not different.
|
|
Respiratory, thoracic and mediastinal disorders
short of breath
|
0.00%
0/151 • One year
Not different.
|
0.67%
1/150 • One year
Not different.
|
|
Infections and infestations
laryngitis
|
0.66%
1/151 • One year
Not different.
|
0.00%
0/150 • One year
Not different.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/151 • One year
Not different.
|
0.67%
1/150 • One year
Not different.
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/151 • One year
Not different.
|
0.67%
1/150 • One year
Not different.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place