Asthma in ChildrenNCT03317977
Translating an Efficacious Illness Management Intervention for Youth With Asthma
A study testing MATCH in people with Asthma in Children, run by Wayne State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- MATCH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 8 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Adolescent/Parent:
- Child aged 12 years, 0 months to 16 years, 11 months
- Moderate to severe persistent asthma
- Child seen in the CHM emergency department for treatment of asthma exacerbation
- Child has experienced 2 or more ED visits and/ or inpatient admissions in prior 12 months (i.e. poorly controlled asthma)
- Parent/ legal guardian willing to participate in home-based family treatment
- Child and family resides within 20 miles of CHM (allows for home-based data collection and intervention)
Who cannot join
- Adolescent/Parent:
- Child is currently in an out-of-home placement
- Schizophrenia or other psychosis on the part of the youth or parent
- Current suicidality or homicidality on the part of the youth or parent
- Cognitive impairment or learning disability that prevents comprehension of research measures on the part of parent or youth
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Michigan
Detroit, Michigan, 48201
About this study
Official title: Translating an Efficacious Illness Management Intervention for Youth With Poorly Controlled Asthma to Real World Settings
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.
Read the 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.
- Conditions
- Asthma in Children
- Being tested
- Reach for Control, MATCH
- Keywords
- Asthma management, adolescents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reach for ControlBehavioural
Also called RFC
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
MATCHBehavioural
Managing Asthma Through Case Management in Home (MATCH) is the current intervention provided by WCHAP to youth with poorly controlled asthma and their families.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Reach for Control |
| Michigan MATCH | Active comparator | Program endorsed by the State of Michigan for treatment of poorly controlled asthma. Receives: Behavioral: MATCH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Emergency Department Visits
Emergency department visits will be obtained from electronic medical records
Measured: Change from Baseline at 6 months, 12 months, and 18 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: Change from Baseline at 6 months, change from Baseline at 12 months and change from Baseline at 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start1 Feb 2018
- Primary completion8 Aug 2023
- Study completion8 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Deborah Ellis, Ph.D., Wayne State University
- Investigators
- Deborah A Ellis, Ph.D, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317977
- Sponsor's protocol ID
- 071217MP4E
- Other IDs
- R01HL138633-01A1
- Status last verified
- Apr 2024
- First submitted
- 18 Oct 2017
- Last updated
- 4 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translating an Efficacious Illness Management Intervention for Youth With Poorly Controlled Asthma to Real World Settings
- ClinicalTrials.gov ID
- NCT03317977
- Acronym / sponsor ID
- 071217MP4E
- Conditions
- Asthma in Children
- Keywords
- Asthma management, adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 8 Aug 2023 (actual)
- Study completion
- 8 Aug 2023 (actual)
- First posted
- 23 Oct 2017 (actual)
- Results
- Posted 4 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reach for Control | Experimental | Behavioral: Reach for ControlReach 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. |
| Michigan MATCH | Active comparator | Behavioral: MATCHProgram endorsed by the State of Michigan for treatment of poorly controlled asthma. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Child aged 12 years, 0 months to 16 years, 11 months
- Moderate to severe persistent asthma
- Child seen in the CHM emergency department for treatment of asthma exacerbation
- Child has experienced 2 or more ED visits and/ or inpatient admissions in prior 12 months (i.e. poorly controlled asthma)
- Parent/ legal guardian willing to participate in home-based family treatment
Key exclusion criteria (5 listed)
- Child is currently in an out-of-home placement
- Schizophrenia or other psychosis on the part of the youth or parent
- Current suicidality or homicidality on the part of the youth or parent
- Cognitive impairment or learning disability that prevents comprehension of research measures on the part of parent or youth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reach for ControlAlso: RFCIn 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 | Behavioural | Reach for Control |
| MATCHManaging Asthma Through Case Management in Home (MATCH) is the current intervention provided by WCHAP to youth with poorly controlled asthma and their families. | Behavioural | Michigan MATCH |
Primary outcome
Number of Emergency Department Visits
Time frame: Change from Baseline at 6 months, 12 months, and 18 months
Emergency department visits will be obtained from electronic medical records
2 secondary outcomes
Family Asthma Management System Scale
Time frame: Change from Baseline at 6 months, change from Baseline at 12 months and change from Baseline at 18 months
Asthma Symptom Frequency
Time frame: Change from Baseline at 6 months, change from Baseline at 12 months and change from Baseline at 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Asthma in Children
Not yet recruiting
Asthma Ctrl SMART Trial
Asthma in Children, Asthma Chronic
Not yet recruiting
Artificially Intelligent Robot Control
Asthma in Children, Artificial Intelligence
Not yet recruiting
Bilevel Positive Airway Pressure (BPAP) for Severe Asthma
Pediatric Asthma, Acute Asthma
Recruiting
Effects of Tele-rehabilitation-Guided Qigong on Children and Adolescents With Asthma
Asthma Childhood
Enrolling by invitationObservational study
Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.
Lung Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah A Ellis, Ph.D principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MATCH in people with Asthma in Children, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Emergency Department Visits (time frame: Change from Baseline at 6 months, 12 months, and 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.