Trial Outcomes & Findings for Translating an Efficacious Illness Management Intervention for Youth With Asthma (NCT NCT03317977)
NCT ID: NCT03317977
Last Updated: 2024-04-04
Results Overview
Emergency department visits will be obtained from electronic medical records
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
Change from Baseline at 6 months, 12 months, and 18 months
Results posted on
2024-04-04
Participant Flow
Participants were recruited from the emergency department of a large urban tertiary care pediatric hospital
Participant milestones
| Measure |
Reach for Control
Reach For Control is a multi-component, home-based family therapy that targets the multiple causes of poor adolescent asthma management across individual, family and community systems.
Reach for Control: In Phase 1 (weeks 1-4), the CHW conducts an initial intake and then completes a comprehensive functional analysis (FA) of behavior to determine the causes of poor asthma management for each youth regarding asthma management. In Phase 2 (weeks 5-20) is a treatment phase and consists of a combination of mandatory cognitive-behavioral skills training (CBST) modules (received by all families) and flexible CBST modules chosen and individualized based on the results of the Phase 1 FA. This includes but not limited to In-vivo Asthma Skills Training, Improving Family Communication and Behavioral Contracting. Phase 3 (weeks 21-24) involves termination planning and relapse prevention
|
Michigan MATCH
Managing Asthma Through Case Management in Home (MATCH) is the current intervention provided by WCHAP to youth with poorly controlled asthma and their families.The program has been endorsed by the State of Michigan as a model program for poorly controlled asthma.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
39
|
|
Overall Study
COMPLETED
|
31
|
35
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Translating an Efficacious Illness Management Intervention for Youth With Asthma
Baseline characteristics by cohort
| Measure |
Reach for Control
n=36 Participants
Reach For Control is a multi-component, home-based family therapy that targets the multiple causes of poor adolescent asthma management across individual, family and community systems.
Reach for Control: In Phase 1 (weeks 1-4), the CHW conducts an initial intake and then completes a comprehensive functional analysis (FA) of behavior to determine the causes of poor asthma management for each youth regarding asthma management. In Phase 2 (weeks 5-20) is a treatment phase and consists of a combination of mandatory cognitive-behavioral skills training (CBST) modules (received by all families) and flexible CBST modules chosen and individualized based on the results of the Phase 1 FA. This includes but not limited to In-vivo Asthma Skills Training, Improving Family Communication and Behavioral Contracting. Phase 3 (weeks 21-24) involves termination planning and relapse prevention
|
Michigan MATCH
n=38 Participants
Managing Asthma Through Case Management in Home (MATCH) is the current intervention provided by WCHAP to youth with poorly controlled asthma and their families.The program has been endorsed by the State of Michigan as a model program for poorly controlled asthma.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.5 years
STANDARD_DEVIATION 1.3 • n=5 Participants
|
14.4 years
STANDARD_DEVIATION 1.4 • n=7 Participants
|
14.4 years
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
38 participants
n=7 Participants
|
74 participants
n=5 Participants
|
|
Asthma Control Test
|
18.9 units on a scale
STANDARD_DEVIATION 3.8 • n=5 Participants
|
18.5 units on a scale
STANDARD_DEVIATION 4.4 • n=7 Participants
|
18.7 units on a scale
STANDARD_DEVIATION 4.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline at 6 months, 12 months, and 18 monthsPopulation: All randomized participants were analyzed with the exception of study removals
Emergency department visits will be obtained from electronic medical records
Outcome measures
| Measure |
Reach for Control
n=36 Participants
Reach For Control is a multi-component, home-based family therapy that targets the multiple causes of poor adolescent asthma management across individual, family and community systems.
Reach for Control: In Phase 1 (weeks 1-4), the CHW conducts an initial intake and then completes a comprehensive functional analysis (FA) of behavior to determine the causes of poor asthma management for each youth regarding asthma management. In Phase 2 (weeks 5-20) is a treatment phase and consists of a combination of mandatory cognitive-behavioral skills training (CBST) modules (received by all families) and flexible CBST modules chosen and individualized based on the results of the Phase 1 FA. This includes but not limited to In-vivo Asthma Skills Training, Improving Family Communication and Behavioral Contracting. Phase 3 (weeks 21-24) involves termination planning and relapse prevention
|
Michigan MATCH
n=38 Participants
Managing Asthma Through Case Management in Home (MATCH) is the current intervention provided by WCHAP to youth with poorly controlled asthma and their families.The program has been endorsed by the State of Michigan as a model program for poorly controlled asthma.
|
|---|---|---|
|
Number of Emergency Department Visits
12-month change
|
0.14 Count of ED visits in prior six months
Standard Deviation 0.42
|
0.26 Count of ED visits in prior six months
Standard Deviation 0.55
|
|
Number of Emergency Department Visits
Baseline
|
0.67 Count of ED visits in prior six months
Standard Deviation 0.79
|
0.68 Count of ED visits in prior six months
Standard Deviation 0.70
|
|
Number of Emergency Department Visits
6-month change
|
0.28 Count of ED visits in prior six months
Standard Deviation 0.45
|
0.50 Count of ED visits in prior six months
Standard Deviation 1.18
|
|
Number of Emergency Department Visits
18-month change
|
0.08 Count of ED visits in prior six months
Standard Deviation 0.28
|
0.03 Count of ED visits in prior six months
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: Change from Baseline at 6 months, change from Baseline at 12 months and change from Baseline at 18 monthsIdentifies family strengths and weaknesses in the management of pediatric asthma across a variety of domains. This is a semi-structured interview that is rated on seven to nine 9-point subscales with higher scores indicating better management. The rating manual provides elaboration and brief examples at key anchor points for each rating scale. A FAMSS summary score is computed for each family by taking a mean across all subscales.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline at 6 months, change from Baseline at 12 months and change from Baseline at 18 monthsSelf report assessing wheezing, nighttime symptoms, speech limitations and activity limitations.
Outcome measures
Outcome data not reported
Adverse Events
Reach for Control
Serious events: 4 serious events
Other events: 18 other events
Deaths: 0 deaths
Michigan MATCH
Serious events: 7 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Reach for Control
n=36 participants at risk
Reach For Control is a multi-component, home-based family therapy that targets the multiple causes of poor adolescent asthma management across individual, family and community systems.
Reach for Control: In Phase 1 (weeks 1-4), the CHW conducts an initial intake and then completes a comprehensive functional analysis (FA) of behavior to determine the causes of poor asthma management for each youth regarding asthma management. In Phase 2 (weeks 5-20) is a treatment phase and consists of a combination of mandatory cognitive-behavioral skills training (CBST) modules (received by all families) and flexible CBST modules chosen and individualized based on the results of the Phase 1 FA. This includes but not limited to In-vivo Asthma Skills Training, Improving Family Communication and Behavioral Contracting. Phase 3 (weeks 21-24) involves termination planning and relapse prevention
|
Michigan MATCH
n=38 participants at risk
Managing Asthma Through Case Management in Home (MATCH) is the current intervention provided by WCHAP to youth with poorly controlled asthma and their families.The program has been endorsed by the State of Michigan as a model program for poorly controlled asthma.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization
|
11.1%
4/36 • Number of events 6 • 1 year
|
13.2%
5/38 • Number of events 8 • 1 year
|
|
Social circumstances
New Family Problem
|
0.00%
0/36 • 1 year
|
2.6%
1/38 • Number of events 1 • 1 year
|
|
General disorders
New Health Problem
|
0.00%
0/36 • 1 year
|
2.6%
1/38 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Reach for Control
n=36 participants at risk
Reach For Control is a multi-component, home-based family therapy that targets the multiple causes of poor adolescent asthma management across individual, family and community systems.
Reach for Control: In Phase 1 (weeks 1-4), the CHW conducts an initial intake and then completes a comprehensive functional analysis (FA) of behavior to determine the causes of poor asthma management for each youth regarding asthma management. In Phase 2 (weeks 5-20) is a treatment phase and consists of a combination of mandatory cognitive-behavioral skills training (CBST) modules (received by all families) and flexible CBST modules chosen and individualized based on the results of the Phase 1 FA. This includes but not limited to In-vivo Asthma Skills Training, Improving Family Communication and Behavioral Contracting. Phase 3 (weeks 21-24) involves termination planning and relapse prevention
|
Michigan MATCH
n=38 participants at risk
Managing Asthma Through Case Management in Home (MATCH) is the current intervention provided by WCHAP to youth with poorly controlled asthma and their families.The program has been endorsed by the State of Michigan as a model program for poorly controlled asthma.
|
|---|---|---|
|
Social circumstances
New Family Problem
|
13.9%
5/36 • Number of events 5 • 1 year
|
15.8%
6/38 • Number of events 8 • 1 year
|
|
General disorders
New Health Problem
|
25.0%
9/36 • Number of events 13 • 1 year
|
13.2%
5/38 • Number of events 6 • 1 year
|
|
Social circumstances
New Problem with Parent-Child Relations
|
5.6%
2/36 • Number of events 2 • 1 year
|
13.2%
5/38 • Number of events 5 • 1 year
|
|
Psychiatric disorders
New Psychiatric Problem
|
8.3%
3/36 • Number of events 3 • 1 year
|
5.3%
2/38 • Number of events 2 • 1 year
|
|
Social circumstances
New School-Related Problem
|
8.3%
3/36 • Number of events 3 • 1 year
|
5.3%
2/38 • Number of events 2 • 1 year
|
|
Social circumstances
Worsening Family Problem
|
5.6%
2/36 • Number of events 2 • 1 year
|
2.6%
1/38 • Number of events 1 • 1 year
|
|
General disorders
Worsening Health Problem
|
30.6%
11/36 • Number of events 15 • 1 year
|
36.8%
14/38 • Number of events 37 • 1 year
|
|
Psychiatric disorders
Worsening Psychiatric Problem
|
2.8%
1/36 • Number of events 1 • 1 year
|
0.00%
0/38 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place