Clinical trial NCT03317977: Translating an Efficacious Illness Management Intervention for Youth With Asthma
Official title: Translating an Efficacious Illness Management Intervention for Youth With Poorly Controlled Asthma to Real World Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma in Children
Keywords: Asthma management, adolescents
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-10-23
Enrollment: 75
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Emergency Department Visits
timeFrame: Change from Baseline at 6 months, 12 months, and 18 months
Secondary outcomes:
measure: Family Asthma Management System Scale
timeFrame: Change from Baseline at 6 months, change from Baseline at 12 months and change from Baseline at 18 months
measure: Asthma Symptom Frequency
timeFrame: Change from Baseline at 6 months, change from Baseline at 12 months and change from Baseline at 18 months
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
Study officials:
affiliation: Wayne State University
name: Deborah A Ellis, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: