Trial Outcomes & Findings for Asthma Action at Erie Trial (NCT NCT02481986)

NCT ID: NCT02481986

Last Updated: 2021-12-09

Results Overview

Asthma Control Test (12 years or older) or Childhood Asthma Control Test (under 12 years old) minimum 5, maximum 27, higher score means better asthma control

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 223 participants
• Primary outcome timeframe: assessed 12-months from baseline, assessed over past 4 weeks
• Results posted on: 2021-12-09

Participant Flow

Participant milestones

Measure	Community Health Worker Participants in this arm will be offered 10 home visits in a 12-month period from community health workers (CHWs). Visits will cover a core asthma curriculum and provide social support. Community Health Worker: A community health worker is para-professional who performs education, case management, and social support.	Certified Asthma Educator Participants in this arm will be offered 2 education sessions with a certified asthma educator in the clinic at start of the study and again at 6-months. These sessions will be followed by a telephone call from the certified asthma educator several weeks after the sessions. Certified asthma educator: A certified asthma educator has is certified and performs asthma education.
Overall Study STARTED	108	115
Overall Study COMPLETED	103	106
Overall Study NOT COMPLETED	5	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

One family did not answer child race. Note that race and ethnicity were asked as separate questions.

Baseline characteristics by cohort

Measure	Community Health Worker n=108 Participants Participants in this arm will be offered 10 home visits in a 12-month period from community health workers (CHWs). Visits will cover a core asthma curriculum and provide social support. Community Health Worker: A community health worker is para-professional who performs education, case management, and social support.	Certified Asthma Educator n=115 Participants Participants in this arm will be offered 2 education sessions with a certified asthma educator in the clinic at start of the study and again at 6-months. These sessions will be followed by a telephone call from the certified asthma educator several weeks after the sessions. Certified asthma educator: A certified asthma educator has is certified and performs asthma education.	Total n=223 Participants Total of all reporting groups
Age, Categorical <=18 years	108 Participants n=108 Participants	115 Participants n=115 Participants	223 Participants n=223 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=108 Participants	0 Participants n=115 Participants	0 Participants n=223 Participants
Age, Categorical >=65 years	0 Participants n=108 Participants	0 Participants n=115 Participants	0 Participants n=223 Participants
Age, Continuous	9.3 years STANDARD_DEVIATION 2.9 • n=108 Participants	9.5 years STANDARD_DEVIATION 3.2 • n=115 Participants	9.4 years STANDARD_DEVIATION 3.0 • n=223 Participants
Sex: Female, Male Female	46 Participants n=108 Participants	52 Participants n=115 Participants	98 Participants n=223 Participants
Sex: Female, Male Male	62 Participants n=108 Participants	63 Participants n=115 Participants	125 Participants n=223 Participants
Race/Ethnicity, Customized Hispanic ethnicity child	92 Participants n=108 Participants • One family did not answer child race. Note that race and ethnicity were asked as separate questions.	98 Participants n=115 Participants • One family did not answer child race. Note that race and ethnicity were asked as separate questions.	190 Participants n=223 Participants • One family did not answer child race. Note that race and ethnicity were asked as separate questions.
Race/Ethnicity, Customized Not Hispanic ethnicity child	16 Participants n=108 Participants • One family did not answer child race. Note that race and ethnicity were asked as separate questions.	17 Participants n=115 Participants • One family did not answer child race. Note that race and ethnicity were asked as separate questions.	33 Participants n=223 Participants • One family did not answer child race. Note that race and ethnicity were asked as separate questions.
Race/Ethnicity, Customized Black race child	18 Participants n=108 Participants • One family did not answer child race. Note that race and ethnicity were asked as separate questions.	21 Participants n=114 Participants • One family did not answer child race. Note that race and ethnicity were asked as separate questions.	39 Participants n=222 Participants • One family did not answer child race. Note that race and ethnicity were asked as separate questions.
Race/Ethnicity, Customized Not Black race child	90 Participants n=108 Participants • One family did not answer child race. Note that race and ethnicity were asked as separate questions.	93 Participants n=114 Participants • One family did not answer child race. Note that race and ethnicity were asked as separate questions.	183 Participants n=222 Participants • One family did not answer child race. Note that race and ethnicity were asked as separate questions.
Region of Enrollment United States	108 participants n=108 Participants	115 participants n=115 Participants	223 participants n=223 Participants

PRIMARY outcome

Timeframe: assessed 12-months from baseline, assessed over past 4 weeks

Asthma Control Test (12 years or older) or Childhood Asthma Control Test (under 12 years old) minimum 5, maximum 27, higher score means better asthma control

Outcome measures

Measure	Community Health Worker n=103 Participants Participants in this arm will be offered 10 home visits in a 12-month period from community health workers (CHWs). Visits will cover a core asthma curriculum and provide social support. Community Health Worker: A community health worker is para-professional who performs education, case management, and social support.	Certified Asthma Educator n=106 Participants Participants in this arm will be offered 2 education sessions with a certified asthma educator in the clinic at start of the study and again at 6-months. These sessions will be followed by a telephone call from the certified asthma educator several weeks after the sessions. Certified asthma educator: A certified asthma educator has is certified and performs asthma education.
Asthma Control Test/Childhood Asthma Control Test at 12-months	21.23 score on a scale Interval 19.82 to 22.63	20.58 score on a scale Interval 19.31 to 21.85

PRIMARY outcome

Timeframe: assessed 12-months after baseline, assessed over past 14 days

Days of activity limitation over past 14 days minimum 0, maximum 14, higher means worse asthma control

Outcome measures

Measure	Community Health Worker n=103 Participants Participants in this arm will be offered 10 home visits in a 12-month period from community health workers (CHWs). Visits will cover a core asthma curriculum and provide social support. Community Health Worker: A community health worker is para-professional who performs education, case management, and social support.	Certified Asthma Educator n=106 Participants Participants in this arm will be offered 2 education sessions with a certified asthma educator in the clinic at start of the study and again at 6-months. These sessions will be followed by a telephone call from the certified asthma educator several weeks after the sessions. Certified asthma educator: A certified asthma educator has is certified and performs asthma education.
Activity Limitation at 12-months	0.42 ratio of days Interval 0.04 to 0.8	0.88 ratio of days Interval 0.52 to 1.23

SECONDARY outcome

Timeframe: assessed 12-months after baseline, prior week assessed

Asthma Control Questionnaire minimum 0, maximum 6, higher score means worse asthma control

Outcome measures

Measure	Community Health Worker n=103 Participants Participants in this arm will be offered 10 home visits in a 12-month period from community health workers (CHWs). Visits will cover a core asthma curriculum and provide social support. Community Health Worker: A community health worker is para-professional who performs education, case management, and social support.	Certified Asthma Educator n=106 Participants Participants in this arm will be offered 2 education sessions with a certified asthma educator in the clinic at start of the study and again at 6-months. These sessions will be followed by a telephone call from the certified asthma educator several weeks after the sessions. Certified asthma educator: A certified asthma educator has is certified and performs asthma education.
Asthma Control Questionnaire at 12-months	0.80 score on a scale Interval 0.57 to 1.04	0.88 score on a scale Interval 0.66 to 1.09

SECONDARY outcome

Timeframe: assessed 12-months after baseline, assessed from baseline to 12-months

Any ED visits or hospitalizations for asthma (each ED visit or hospitalization is a single event, ED visits that transition into hospitalizations are coded as one event)

Outcome measures

Measure	Community Health Worker n=103 Participants Participants in this arm will be offered 10 home visits in a 12-month period from community health workers (CHWs). Visits will cover a core asthma curriculum and provide social support. Community Health Worker: A community health worker is para-professional who performs education, case management, and social support.	Certified Asthma Educator n=106 Participants Participants in this arm will be offered 2 education sessions with a certified asthma educator in the clinic at start of the study and again at 6-months. These sessions will be followed by a telephone call from the certified asthma educator several weeks after the sessions. Certified asthma educator: A certified asthma educator has is certified and performs asthma education.
Health Care Utilization at 12-months	0.11 events Interval 0.07 to 0.18	0.20 events Interval 0.13 to 0.28

SECONDARY outcome

Timeframe: assessed 12-months from baseline, assessed from baseline to 12-months

This measure is the total dollars spent to deliver the intervention by arm. Costs include CHW and AE-C salaries, supervision, training costs, and intervention materials that resulted in 84 AE-visits and 722 CHW visits.

Outcome measures

Measure	Community Health Worker n=108 Participants Participants in this arm will be offered 10 home visits in a 12-month period from community health workers (CHWs). Visits will cover a core asthma curriculum and provide social support. Community Health Worker: A community health worker is para-professional who performs education, case management, and social support.	Certified Asthma Educator n=115 Participants Participants in this arm will be offered 2 education sessions with a certified asthma educator in the clinic at start of the study and again at 6-months. These sessions will be followed by a telephone call from the certified asthma educator several weeks after the sessions. Certified asthma educator: A certified asthma educator has is certified and performs asthma education.
Costs of Intervention Delivery	53390 dollars spent per arm on intervention	11373 dollars spent per arm on intervention

Adverse Events

Community Health Worker

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Certified Asthma Educator

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

Molly A Martin, MD

University of Illinois Chicago

Phone: 312-996-2363

Email: mollyma@uic.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place