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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL138633-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reach for Control | Experimental | 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. |
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| Michigan MATCH | Active Comparator | Program endorsed by the State of Michigan for treatment of poorly controlled asthma. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reach for Control | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Emergency Department Visits | Emergency department visits will be obtained from electronic medical records | Change from Baseline at 6 months, 12 months, and 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Adolescent/Parent:
Exclusion Criteria:
Adolescent/Parent:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah A Ellis, Ph.D | Wayne State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Michigan | Detroit | Michigan | 48201 | United States |
Data will be made available at the end of the study through presentations at scientific conferences and publications in peer-reviewed scientific journals. All final peer-reviewed manuscripts that result from the study will be submitted to PubMed Central. In addition, final dataset from the trial will be shared. Identifiers will be removed from the data prior to any release of the dataset.
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Indefinitely
In light of the sensitive nature of the treatment data contained in the data set, as well as the participation of children, data and associated documentation will be made available to users only under a specific data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying the data after analyses are completed. Furthermore, audiotaped session recordings will not be shared, as these include voice identifiers and it is not possible to de-identify the recordings; costs of transcription of sessions given their length and number are beyond the scope of the study.
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Participants were recruited from the emergency department of a large urban tertiary care pediatric hospital
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Emergency Department Visits | Emergency department visits will be obtained from electronic medical records | All randomized participants were analyzed with the exception of study removals | Posted | Mean | Standard Deviation | Count of ED visits in prior six months | Change from Baseline at 6 months, 12 months, and 18 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Hospitalization for an asthma related event. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| New Family Problem | Social circumstances | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deborah Ellis, Ph.D. | Wayne State University | 313-577-1055 | dellis@med.wayne.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 12, 2024 | Feb 12, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 28, 2023 | Mar 27, 2024 | ICF_001.pdf |
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| MATCH | Behavioral | Managing Asthma Through Case Management in Home (MATCH) is the current intervention provided by WCHAP to youth with poorly controlled asthma and their families. |
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| Change from Baseline at 6 months, change from Baseline at 12 months and change from Baseline at 18 months |
| Asthma Symptom Frequency | Self report assessing wheezing, nighttime symptoms, speech limitations and activity limitations. | Change from Baseline at 6 months, change from Baseline at 12 months and change from Baseline at 18 months |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Asthma Control Test | The measure is a self-report questionnaire that consists of five items: activity limitation, shortness of breath, night-time awakenings due to asthma symptoms, use of quick- relief medication and a global rating of asthma control. Items are rated on a 1-5 scale over the past four weeks, with higher scores indicating better control over asthma symptoms. The total score ranges from 5 to 25 with higher scores indicating better control over asthma symptoms. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. |
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| 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. | Not Posted | Change from Baseline at 6 months, change from Baseline at 12 months and change from Baseline at 18 months | Participants |
| Secondary | Asthma Symptom Frequency | Self report assessing wheezing, nighttime symptoms, speech limitations and activity limitations. | Not Posted | Change from Baseline at 6 months, change from Baseline at 12 months and change from Baseline at 18 months | Participants |
| 0 |
| 36 |
| 4 |
| 36 |
| 18 |
| 36 |
| EG001 | 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. | 0 | 38 | 7 | 38 | 20 | 38 |
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| New Family Problem | Social circumstances | Systematic Assessment |
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| New Health Problem | General disorders | Systematic Assessment | New health problem not related to asthma. |
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| New Health Problem | General disorders | Systematic Assessment |
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| New Problem with Parent-Child Relations | Social circumstances | Systematic Assessment |
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| New Psychiatric Problem | Psychiatric disorders | Systematic Assessment |
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| New School-Related Problem | Social circumstances | Systematic Assessment |
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| Worsening Family Problem | Social circumstances | Systematic Assessment |
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| Worsening Health Problem | General disorders | Systematic Assessment |
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| Worsening Psychiatric Problem | Psychiatric disorders | Systematic Assessment |
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