Asthma in Children
Conditions
Keywords
Asthma management, adolescents
Brief summary
The propose of the study is to test the effectiveness of Reach for Control (RFC) as compared to Michigan MATCH to improve asthma symptoms, asthma management and lung functioning and to decrease ED visits and admissions for youth with poorly controlled asthma when integrated into hospital emergency departments and delivered by community health workers. The study is a hybrid implementation-effectiveness design and will test RFC for use in real world, public healthcare settings.
Detailed description
The study was conducted in the emergency department at Children's Hospital of Michigan; CHM). 170 adolescents with poorly controlled asthma and their primary caregivers will be enrolled. Prior to the COVID-19 pandemic, families were randomly assigned to six months of home-based family treatment consisting of either RFC or Michigan MATCH , a model program endorsed by the State of Michigan for treatment of poorly controlled asthma. Subsequently, all intervention content in both arms was delivered by telehealth. Treatment content of RFC consists of weekly sessions focusing on asthma education, asthma management skills, improving home-school community for asthma, access to care and case management. MATCH includes asthma education but is less intensive and does not focus on family management skills. Treatment was provided by community health workers (CHWs) employed by a community agency providing MATCH as their standard of care. Consent and data collection was completed at baseline with additional data collection visits at 6, 12 and 18 months after baseline. Data collection was completed by project research assistants and consists of questionnaires and interviews with the adolescent and parent to assess asthma management, asthma symptoms and hospital utilization. The data analyses were intent-to-treat, meaning that all randomized participants are included regardless of the intervention dose received. Trial data were analyzed using linear mixed effect models.
Interventions
BEHAVIORALReach 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
BEHAVIORALMATCH
Managing Asthma Through Case Management in Home (MATCH) is the current intervention provided by WCHAP to youth with poorly controlled asthma and their families.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Wayne State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
Adolescent/Parent: 1. Child aged 12 years, 0 months to 16 years, 11 months 2. Moderate to severe persistent asthma 3. Child seen in the CHM emergency department for treatment of asthma exacerbation 4. Child has experienced 2 or more ED visits and/ or inpatient admissions in prior 12 months (i.e. poorly controlled asthma) 5. Parent/ legal guardian willing to participate in home-based family treatment 6. Child and family resides within 20 miles of CHM (allows for home-based data collection and intervention)
Exclusion criteria
Adolescent/Parent: 1. Child is currently in an out-of-home placement 2. Schizophrenia or other psychosis on the part of the youth or parent 3. Current suicidality or homicidality on the part of the youth or parent 4. Cognitive impairment or learning disability that prevents comprehension of research measures on the part of parent or youth
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Emergency Department Visits | Change from Baseline at 6 months, 12 months, and 18 months | Emergency department visits will be obtained from electronic medical records |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Family Asthma Management System Scale | Change from Baseline at 6 months, change from Baseline at 12 months and change from Baseline at 18 months | Identifies 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. |
| Asthma Symptom Frequency | Change from Baseline at 6 months, change from Baseline at 12 months and change from Baseline at 18 months | Self report assessing wheezing, nighttime symptoms, speech limitations and activity limitations. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the emergency department of a large urban tertiary care pediatric hospital
Participants by arm
| Arm | Count |
|---|---|
| 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 | 36 |
| 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. | 38 |
| Total | 74 |
Baseline characteristics
| Characteristic | Reach for Control | Michigan MATCH | Total |
|---|---|---|---|
| Age, Continuous | 14.5 years STANDARD_DEVIATION 1.3 | 14.4 years STANDARD_DEVIATION 1.4 | 14.4 years STANDARD_DEVIATION 1.3 |
| Asthma Control Test | 18.9 units on a scale STANDARD_DEVIATION 3.8 | 18.5 units on a scale STANDARD_DEVIATION 4.4 | 18.7 units on a scale STANDARD_DEVIATION 4.1 |
| Race/Ethnicity, Customized Black | 35 Participants | 35 Participants | 70 Participants |
| Race/Ethnicity, Customized White | 1 Participants | 3 Participants | 4 Participants |
| Region of Enrollment United States | 36 participants | 38 participants | 74 participants |
| Sex: Female, Male Female | 19 Participants | 20 Participants | 39 Participants |
| Sex: Female, Male Male | 17 Participants | 18 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 38 |
| other Total, other adverse events | 18 / 36 | 20 / 38 |
| serious Total, serious adverse events | 4 / 36 | 7 / 38 |
Outcome results
Primary
Number of Emergency Department Visits
Emergency department visits will be obtained from electronic medical records
Time frame: Change from Baseline at 6 months, 12 months, and 18 months
Population: All randomized participants were analyzed with the exception of study removals
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reach for Control | Number of Emergency Department Visits | Baseline | 0.67 Count of ED visits in prior six months | Standard Deviation 0.79 |
| Reach for Control | Number of Emergency Department Visits | 6-month change | 0.28 Count of ED visits in prior six months | Standard Deviation 0.45 |
| Reach for Control | Number of Emergency Department Visits | 12-month change | 0.14 Count of ED visits in prior six months | Standard Deviation 0.42 |
| Reach for Control | Number of Emergency Department Visits | 18-month change | 0.08 Count of ED visits in prior six months | Standard Deviation 0.28 |
| Michigan MATCH | Number of Emergency Department Visits | 18-month change | 0.03 Count of ED visits in prior six months | Standard Deviation 0.16 |
| Michigan MATCH | Number of Emergency Department Visits | Baseline | 0.68 Count of ED visits in prior six months | Standard Deviation 0.7 |
| Michigan MATCH | Number of Emergency Department Visits | 12-month change | 0.26 Count of ED visits in prior six months | Standard Deviation 0.55 |
| Michigan MATCH | Number of Emergency Department Visits | 6-month change | 0.50 Count of ED visits in prior six months | Standard Deviation 1.18 |
p-value: 0.43Mixed Models Analysis
Secondary
Asthma Symptom Frequency
Self report assessing wheezing, nighttime symptoms, speech limitations and activity limitations.
Time frame: Change from Baseline at 6 months, change from Baseline at 12 months and change from Baseline at 18 months
Secondary
Family Asthma Management System Scale
Identifies 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.
Time frame: Change from Baseline at 6 months, change from Baseline at 12 months and change from Baseline at 18 months