Have you or your loved ones been diagnosed with asthma in children?

You may be eligible to participate in a asthma in children clinical trial.

Have you or your loved ones been diagnosed with asthma in children? You may be eligible to participate in a asthma in children clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Asthma in Children Clinical Trial in Detroit MI

NCT03317977 | Interventional

Have you or your loved ones been diagnosed with asthma in children?

You may be eligible to participate in a asthma in children clinical trial.

Have you or your loved ones been diagnosed with asthma in children? You may be eligible to participate in a asthma in children clinical trial.

Active not recruiting

Male & Female

12 - 16

Years old

This study is looking to recruit 170 Participants

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.

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Details for the study

Brief Title

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

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 will be 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. Families will be 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. 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 will be provided
by community health workers (CHWs) employed by a community agency providing MATCH as their
standard of care. Consent and data collection will be completed in the home at baseline with
additional data collection visits at 6, 12 and 18 months after baseline. Data collection is
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 adolescent also completes a pulmonary function test on a portable spirometer
and is observed using medication devices to assess asthma care skills objectively.The data
analyses will be intent-to-treat, meaning that all randomized participants are included
regardless of the intervention dose received. Trial data will analyzed using the linear mixed
effect models.

Treatments and/or Procedures

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.

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

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

Pulmonary Functioning (FEV1)

Spirometry will be obtained using a portable calibrated recording spirometer.

Change from Baseline at 6 months, change from Baseline at 12 months and change from Baseline at 18 months

Secondary

Asthma Device Use Skills

Observational measure where device use competency is rated during adolescent demonstration of use of their own quick relief and controller medication devices.

Change from Baseline at 6 months, change from Baseline at 12 months and change from Baseline at 18 months

Secondary

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

Secondary

Number of emergency department visits, hospitalizations, and total hospital days

Hospitalizations will be obtained from electronic medical records and service utilization forms

Change from Baseline at 3 months, Change from Baseline at 6 months, change from Baseline at 9 months, change from Baseline at 12 months, change from Baseline at 15 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.

Change from Baseline at 6 months, change from Baseline at 12 months and change from Baseline at 18 months

Study 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