Trial Outcomes & Findings for A Patient Advocate to Improve Real-world Asthma Management for Inner City Adults (NCT NCT01972308)
NCT ID: NCT01972308
Last Updated: 2022-09-13
Results Overview
Asthma Control Questionnaire: In a randomized controlled trial we will assess whether 6 months of the Patient Advocate Intervention improves asthma control relative to baseline compared with usual care (UC) and whether such a difference is sustained in the 6 months following the intervention's completion. Asthma Control range is 0-6 with lower score better control (0= total control and 6 = extremetly uncontrolled. The minimally important clinical difference is 0.5. A score \> 1.5 is considered inadequate control.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
312 participants
Primary outcome timeframe
baseline and 1 year
Results posted on
2022-09-13
Participant Flow
Participant milestones
| Measure |
Patient Advocate
Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients.
Patient Advocate: Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients
|
Usual Care
Patient receives asthma care as usual from their asthma provider
|
|---|---|---|
|
Overall Study
STARTED
|
156
|
156
|
|
Overall Study
COMPLETED
|
148
|
148
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
Reasons for withdrawal
| Measure |
Patient Advocate
Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients.
Patient Advocate: Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients
|
Usual Care
Patient receives asthma care as usual from their asthma provider
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
6
|
|
Overall Study
Death
|
4
|
1
|
Baseline Characteristics
A Patient Advocate to Improve Real-world Asthma Management for Inner City Adults
Baseline characteristics by cohort
| Measure |
Patient Advocate
n=156 Participants
Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients.
Patient Advocate: Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients
|
Usual Care
n=156 Participants
Patient receives asthma care as usual from their asthma provider
|
Total
n=312 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.6 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
49.6 years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
51.1 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
216 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
142 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
287 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
100 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
asthma control questionnaire
|
2.3 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 1 yearPopulation: 18 years or more, physician's diagnosis of asthma, prescribed an inhaled-steroid for asthma, moderate or severe persistent asthma, evidence of reversible airflow obstruction, at least one appointment scheduled with the asthma physician during the 1st 6 months of participation
Asthma Control Questionnaire: In a randomized controlled trial we will assess whether 6 months of the Patient Advocate Intervention improves asthma control relative to baseline compared with usual care (UC) and whether such a difference is sustained in the 6 months following the intervention's completion. Asthma Control range is 0-6 with lower score better control (0= total control and 6 = extremetly uncontrolled. The minimally important clinical difference is 0.5. A score \> 1.5 is considered inadequate control.
Outcome measures
| Measure |
Patient Advocate
n=156 Participants
Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients.
|
Usual Care
n=156 Participants
Patient receives asthma care as usual from their asthma provider
|
|---|---|---|
|
Change in Asthma Control at One Year
|
-0.42 units on a scale
Interval -0.65 to -0.18
|
-0.11 units on a scale
Interval -0.37 to 0.12
|
SECONDARY outcome
Timeframe: one yearEmergency room visits in the 6 months before entry compared with emergency room visits in the 6 months prior to the one year timepoint
Outcome measures
| Measure |
Patient Advocate
n=156 Participants
Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients.
|
Usual Care
n=156 Participants
Patient receives asthma care as usual from their asthma provider
|
|---|---|---|
|
Change in Emergency Department(ED) Visits at One Year
|
-0.90 visits per 6 months
Interval -1.5 to -0.42
|
-0.24 visits per 6 months
Interval -0.6 to 0.18
|
SECONDARY outcome
Timeframe: baseline to one yearAsthma-related quality of life will be measured with the Mini-Asthma Quality of Life Questionnaire (AQLQ). This 15-item questionnaire with each item having a 7-point response scale that provides a mean summary score. A 0.5-unit change is considered clinically meaningful. the range is 1 - 7 with higher score better quality of life.
Outcome measures
| Measure |
Patient Advocate
n=156 Participants
Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients.
|
Usual Care
n=156 Participants
Patient receives asthma care as usual from their asthma provider
|
|---|---|---|
|
Change in Asthma-related Quality of Life
|
0.28 units on a scale
Interval 0.01 to 0.54
|
0.23 units on a scale
Interval -0.05 to 0.48
|
SECONDARY outcome
Timeframe: one yearParticipants will report hospitalizations verified if possible in participating health systems. We review records and if not available ask patient for hospititalizations over the 6 months before baseline and compare it with the record or report in the 6-months prior to one year.
Outcome measures
| Measure |
Patient Advocate
n=156 Participants
Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients.
|
Usual Care
n=156 Participants
Patient receives asthma care as usual from their asthma provider
|
|---|---|---|
|
Change in Hospitalizations
|
-0.30 hospitalizations per 6 months
Interval -0.66 to -0.06
|
-0.36 hospitalizations per 6 months
Interval -0.66 to -0.12
|
SECONDARY outcome
Timeframe: baseline and one yeara new dose or an increase in already prescribed prednisone dose
Outcome measures
| Measure |
Patient Advocate
n=156 Participants
Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients.
|
Usual Care
n=156 Participants
Patient receives asthma care as usual from their asthma provider
|
|---|---|---|
|
Risk of Prednisone Bursts
|
-0.005 risk of prednisone bursts
Interval -0.1 to 0.1
|
-0.05 risk of prednisone bursts
Interval -0.14 to 0.05
|
SECONDARY outcome
Timeframe: one yearRecords or if not available patient report of an urgent office visit in the 6 months before baseline compared with record or report of urgent office visits in the 6 months prior to one year. An urgent office visit is one scheduled within 24 hours of the visit.
Outcome measures
| Measure |
Patient Advocate
n=156 Participants
Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients.
|
Usual Care
n=156 Participants
Patient receives asthma care as usual from their asthma provider
|
|---|---|---|
|
Change in Urgent Office Visit
|
-0.24 urgent visits per 6 months
Interval -0.54 to 0.02
|
-0.42 urgent visits per 6 months
Interval -0.72 to -0.12
|
Adverse Events
Patient Advocate
Serious events: 89 serious events
Other events: 71 other events
Deaths: 4 deaths
Usual Care
Serious events: 90 serious events
Other events: 74 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Patient Advocate
n=156 participants at risk
Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients.
Patient Advocate: Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients
|
Usual Care
n=156 participants at risk
Patient receives asthma care as usual from their asthma provider
Patient Advocate: Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients
|
|---|---|---|
|
Nervous system disorders
trigeminal neurlagia
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Infections and infestations
ear infection
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Musculoskeletal and connective tissue disorders
shoulder pain
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Cardiac disorders
palpitations
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Nervous system disorders
paresthesia
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Respiratory, thoracic and mediastinal disorders
pleurisy
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Skin and subcutaneous tissue disorders
pruritis
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Renal and urinary disorders
kidney stone
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Reproductive system and breast disorders
reproductive system and breast disorders
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Infections and infestations
sepsis
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Injury, poisoning and procedural complications
seroma
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Respiratory, thoracic and mediastinal disorders
sleep apnea
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Gastrointestinal disorders
small intestine obstruction
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
27.6%
43/156 • one year
|
28.2%
44/156 • one year
|
|
Musculoskeletal and connective tissue disorders
foot pain
|
3.2%
5/156 • one year
|
1.3%
2/156 • one year
|
|
Respiratory, thoracic and mediastinal disorders
short of breath
|
3.8%
6/156 • one year
|
1.9%
3/156 • one year
|
|
Surgical and medical procedures
surgical and medical procedure
|
9.0%
14/156 • one year
|
4.5%
7/156 • one year
|
|
Gastrointestinal disorders
abdominal pain
|
3.8%
6/156 • one year
|
4.5%
7/156 • one year
|
|
Musculoskeletal and connective tissue disorders
back pain
|
2.6%
4/156 • one year
|
5.8%
9/156 • one year
|
|
Cardiac disorders
chest pain
|
3.8%
6/156 • one year
|
3.8%
6/156 • one year
|
|
Immune system disorders
allergic reaction
|
2.6%
4/156 • one year
|
2.6%
4/156 • one year
|
|
Injury, poisoning and procedural complications
fall
|
1.9%
3/156 • one year
|
3.2%
5/156 • one year
|
|
Injury, poisoning and procedural complications
ankle sprain
|
1.9%
3/156 • one year
|
3.2%
5/156 • one year
|
|
Skin and subcutaneous tissue disorders
skin abscess
|
1.9%
3/156 • one year
|
2.6%
4/156 • one year
|
|
Infections and infestations
skin infection
|
2.6%
4/156 • one year
|
1.9%
3/156 • one year
|
|
Infections and infestations
urinary tract infection
|
1.9%
3/156 • one year
|
2.6%
4/156 • one year
|
|
Nervous system disorders
headache
|
1.3%
2/156 • one year
|
3.2%
5/156 • one year
|
|
Injury, poisoning and procedural complications
injury, poisoning and procedural complication
|
2.6%
4/156 • one year
|
1.3%
2/156 • one year
|
|
Cardiac disorders
hypertension
|
2.6%
4/156 • one year
|
1.3%
2/156 • one year
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
1.9%
3/156 • one year
|
1.9%
3/156 • one year
|
|
Infections and infestations
acute sinusitis
|
1.9%
3/156 • one year
|
1.9%
3/156 • one year
|
|
Infections and infestations
upper respiratory infection
|
0.64%
1/156 • one year
|
3.2%
5/156 • one year
|
|
Gastrointestinal disorders
vomiting
|
2.6%
4/156 • one year
|
1.3%
2/156 • one year
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
1.9%
3/156 • one year
|
1.3%
2/156 • one year
|
|
Gastrointestinal disorders
stomach pain
|
1.3%
2/156 • one year
|
1.9%
3/156 • one year
|
|
Musculoskeletal and connective tissue disorders
arthritis
|
0.64%
1/156 • one year
|
1.9%
3/156 • one year
|
|
Gastrointestinal disorders
constipation
|
1.3%
2/156 • one year
|
1.3%
2/156 • one year
|
|
Endocrine disorders
hyperglycemia
|
1.3%
2/156 • one year
|
1.3%
2/156 • one year
|
|
Psychiatric disorders
psychiatric disorder
|
1.9%
3/156 • one year
|
0.64%
1/156 • one year
|
|
Skin and subcutaneous tissue disorders
skin and subcutaneous tissue disorders
|
1.3%
2/156 • one year
|
1.3%
2/156 • one year
|
|
Gastrointestinal disorders
diverticulitis
|
1.3%
2/156 • one year
|
0.64%
1/156 • one year
|
|
Endocrine disorders
hypoglycemia
|
1.3%
2/156 • one year
|
0.64%
1/156 • one year
|
|
Pregnancy, puerperium and perinatal conditions
pregnancy
|
0.00%
0/156 • one year
|
1.9%
3/156 • one year
|
|
Infections and infestations
bronchial infection
|
0.64%
1/156 • one year
|
1.3%
2/156 • one year
|
|
Psychiatric disorders
anxiety
|
0.64%
1/156 • one year
|
0.64%
1/156 • one year
|
|
Cardiac disorders
chest wall pain
|
0.64%
1/156 • one year
|
0.64%
1/156 • one year
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/156 • one year
|
1.3%
2/156 • one year
|
|
General disorders
flu-like symptoms
|
0.00%
0/156 • one year
|
1.3%
2/156 • one year
|
|
Injury, poisoning and procedural complications
fracture
|
0.64%
1/156 • one year
|
0.64%
1/156 • one year
|
|
Gastrointestinal disorders
gastrointestinal disorders
|
0.64%
1/156 • one year
|
0.64%
1/156 • one year
|
|
Respiratory, thoracic and mediastinal disorders
acute and chronic respiratory failure with hypoxia
|
0.64%
1/156 • one year
|
0.64%
1/156 • one year
|
|
Respiratory, thoracic and mediastinal disorders
respiratory, thoracic and medistinal disorders
|
0.64%
1/156 • one year
|
0.64%
1/156 • one year
|
|
Nervous system disorders
seizure
|
0.64%
1/156 • one year
|
0.64%
1/156 • one year
|
|
Skin and subcutaneous tissue disorders
skin ulcer
|
1.3%
2/156 • one year
|
0.00%
0/156 • one year
|
|
Skin and subcutaneous tissue disorders
urticaria
|
1.3%
2/156 • one year
|
0.00%
0/156 • one year
|
|
Reproductive system and breast disorders
vaginal bleeding
|
1.3%
2/156 • one year
|
0.00%
0/156 • one year
|
|
Respiratory, thoracic and mediastinal disorders
wheeze
|
0.00%
0/156 • one year
|
1.3%
2/156 • one year
|
|
Infections and infestations
lung infection
|
0.64%
1/156 • one year
|
0.64%
1/156 • one year
|
|
General disorders
noncardiac chest pain
|
0.00%
0/156 • one year
|
1.3%
2/156 • one year
|
|
Gastrointestinal disorders
GERD
|
0.64%
1/156 • one year
|
0.64%
1/156 • one year
|
|
Immune system disorders
anaphylaxis
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Blood and lymphatic system disorders
anemia
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Injury, poisoning and procedural complications
ankle fracture
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Blood and lymphatic system disorders
blood and lymphatic system disorders
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Eye disorders
blurred vision
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Injury, poisoning and procedural complications
bruising
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Gastrointestinal disorders
colitis
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Eye disorders
conjunctivitis
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Metabolism and nutrition disorders
dehydration
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Gastrointestinal disorders
dental caries
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Psychiatric disorders
depression
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Gastrointestinal disorders
dry mouth
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Ear and labyrinth disorders
ear pain
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Eye disorders
corneal abrasion
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Eye disorders
eye irritation
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Injury, poisoning and procedural complications
facial pain
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
General disorders
fatigue
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
General disorders
fever
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
General disorders
gait disturbance
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Gastrointestinal disorders
gall bladder pain
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
General disorders
general disorders
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Renal and urinary disorders
hematuria
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Immune system disorders
immune system disorders
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Musculoskeletal and connective tissue disorders
knee swelling
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Metabolism and nutrition disorders
metabolism and nutrition disorders
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal and connective tissue disorders
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Nervous system disorders
stroke symptoms
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Psychiatric disorders
suicidal ideation
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Nervous system disorders
transient ischemic attack
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Renal and urinary disorders
urinary retention
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Reproductive system and breast disorders
uterine pain
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Infections and infestations
vaginal infection
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Vascular disorders
deep venous thrombosis
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Cardiac disorders
ventricular arrhrythmia
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Ear and labyrinth disorders
ear and labyrinth disorders
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Eye disorders
corneal ulcer
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Infections and infestations
infection and infestations
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
General disorders
edema
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Cardiac disorders
angina
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Infections and infestations
peritoneal infection
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Respiratory, thoracic and mediastinal disorders
sinus disorder
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Infections and infestations
soft tissue infection
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Infections and infestations
vulvovaginal candidiasis
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Musculoskeletal and connective tissue disorders
foot weakness
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
Other adverse events
| Measure |
Patient Advocate
n=156 participants at risk
Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients.
Patient Advocate: Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients
|
Usual Care
n=156 participants at risk
Patient receives asthma care as usual from their asthma provider
Patient Advocate: Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
18.6%
29/156 • one year
|
19.9%
31/156 • one year
|
|
Respiratory, thoracic and mediastinal disorders
short of breath
|
4.5%
7/156 • one year
|
3.8%
6/156 • one year
|
|
General disorders
foot pain
|
5.1%
8/156 • one year
|
2.6%
4/156 • one year
|
|
Psychiatric disorders
depression
|
2.6%
4/156 • one year
|
2.6%
4/156 • one year
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
3.8%
6/156 • one year
|
1.3%
2/156 • one year
|
|
Nervous system disorders
headache
|
1.3%
2/156 • one year
|
3.2%
5/156 • one year
|
|
Infections and infestations
sinusitis
|
2.6%
4/156 • one year
|
1.9%
3/156 • one year
|
|
Skin and subcutaneous tissue disorders
skin disorders
|
3.8%
6/156 • one year
|
0.64%
1/156 • one year
|
|
Surgical and medical procedures
surgical and medical procedures
|
1.9%
3/156 • one year
|
1.9%
3/156 • one year
|
|
Gastrointestinal disorders
abdominal pain
|
1.3%
2/156 • one year
|
1.9%
3/156 • one year
|
|
Musculoskeletal and connective tissue disorders
back pain
|
1.9%
3/156 • one year
|
1.3%
2/156 • one year
|
|
Cardiac disorders
chest pain
|
1.3%
2/156 • one year
|
1.9%
3/156 • one year
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
1.3%
2/156 • one year
|
1.9%
3/156 • one year
|
|
General disorders
flu-like symptoms
|
1.9%
3/156 • one year
|
1.3%
2/156 • one year
|
|
Immune system disorders
allergic reaction
|
1.3%
2/156 • one year
|
1.3%
2/156 • one year
|
|
Injury, poisoning and procedural complications
fall
|
0.64%
1/156 • one year
|
1.9%
3/156 • one year
|
|
Skin and subcutaneous tissue disorders
abscess
|
0.64%
1/156 • one year
|
1.9%
3/156 • one year
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
0.64%
1/156 • one year
|
1.9%
3/156 • one year
|
|
Infections and infestations
bronchial infection
|
1.9%
3/156 • one year
|
0.64%
1/156 • one year
|
|
Musculoskeletal and connective tissue disorders
arthritis
|
0.00%
0/156 • one year
|
1.9%
3/156 • one year
|
|
Cardiac disorders
hypertension
|
1.9%
3/156 • one year
|
0.00%
0/156 • one year
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
1.3%
2/156 • one year
|
0.64%
1/156 • one year
|
|
Musculoskeletal and connective tissue disorders
arthralgia shoulder
|
1.3%
2/156 • one year
|
0.00%
0/156 • one year
|
|
Gastrointestinal disorders
gastrointestinal disorder
|
0.64%
1/156 • one year
|
0.64%
1/156 • one year
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal and connective tissue disorders
|
0.64%
1/156 • one year
|
0.64%
1/156 • one year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
neoplasm benign
|
0.00%
0/156 • one year
|
1.3%
2/156 • one year
|
|
Infections and infestations
ear infection
|
1.3%
2/156 • one year
|
0.00%
0/156 • one year
|
|
General disorders
pain
|
0.64%
1/156 • one year
|
0.64%
1/156 • one year
|
|
Skin and subcutaneous tissue disorders
cellulitis
|
1.3%
2/156 • one year
|
0.00%
0/156 • one year
|
|
Cardiac disorders
palpitations
|
1.3%
2/156 • one year
|
0.00%
0/156 • one year
|
|
Respiratory, thoracic and mediastinal disorders
respiratory, thoracic, and mediastinal disorders
|
0.64%
1/156 • one year
|
0.64%
1/156 • one year
|
|
Infections and infestations
skin infection
|
0.00%
0/156 • one year
|
1.3%
2/156 • one year
|
|
Gastrointestinal disorders
stomach pain
|
0.00%
0/156 • one year
|
1.3%
2/156 • one year
|
|
Gastrointestinal disorders
GERD
|
0.64%
1/156 • one year
|
0.64%
1/156 • one year
|
|
Respiratory, thoracic and mediastinal disorders
allergic rhinitis
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Blood and lymphatic system disorders
blood and lymphatic system disorders
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Injury, poisoning and procedural complications
bruising
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Cardiac disorders
cardiac disorders
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Musculoskeletal and connective tissue disorders
chest wall pain
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Metabolism and nutrition disorders
dehydration
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Gastrointestinal disorders
dysphagia
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Ear and labyrinth disorders
ear pain
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Gastrointestinal disorders
diverticulitis
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Gastrointestinal disorders
hemorroids
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Metabolism and nutrition disorders
hyperglycemia
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Injury, poisoning and procedural complications
injury, poisoning and procedural complications
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Reproductive system and breast disorders
menorrhagia
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Infections and infestations
pharyngitis
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Pregnancy, puerperium and perinatal conditions
pregnancy, puerperium and perinatal conditions
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Nervous system disorders
presyncope
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Renal and urinary disorders
renal and urinary disorders
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Reproductive system and breast disorders
reproductive system and breast disorders
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Respiratory, thoracic and mediastinal disorders
sinus pain
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Gastrointestinal disorders
toothache
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Nervous system disorders
transient ischemic attack
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
bladder tumor
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Ear and labyrinth disorders
ear and labyrinth disorders
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Eye disorders
corneal ulcer
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Infections and infestations
infections and infestations
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Injury, poisoning and procedural complications
wound complication
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Infections and infestations
esophageal infection
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Infections and infestations
lung infection
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Immune system disorders
autoimmune disorder
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Renal and urinary disorders
dysuria
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
|
Musculoskeletal and connective tissue disorders
noncardiac chest pain
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Renal and urinary disorders
cystitis noninfective
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Skin and subcutaneous tissue disorders
papularpustulo rash
|
0.00%
0/156 • one year
|
0.64%
1/156 • one year
|
|
Musculoskeletal and connective tissue disorders
muscle weakness upper limb
|
0.64%
1/156 • one year
|
0.00%
0/156 • one year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place