Clinical trial NCT03121157: Detroit Young Adult Asthma Project
Official title: Multi-component Technology Intervention for African American Emerging Adults With Asthma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Keywords: African Americans
Emerging adults
Medication adherence
eHealth
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-04-20
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the Detroit Young Adult Asthma Project is to test a technology based program to help African American young adults learn to better manage their asthma. Participants will be randomized to a multi-component technology-based intervention (MCTI) targeting asthma medication adherence or to a comparison control condition.

Detailed description: Racial and ethnic minority youth have poorer asthma status than Caucasian youth, even after controlling for socioeconomic variables. Proper use of asthma controller medications is critical in reducing asthma mortality and morbidity. The clinical consequences of poor asthma management include increased illness complications, excessive functional morbidity, and fatal asthma attacks. There are significant limitations in research on interventions to improve asthma management in racial minority populations, particularly minority adolescents and young adults, though illness management tends to deteriorate after adolescence during emerging adulthood, the unique developmental period beyond adolescence but before adulthood. All elements of the proposed study protocol were piloted in an NHLBI-funded pilot study (1R34HL107664-01A1 MacDonell). Results suggested feasibility and acceptability of the study protocol as well as proof of concept. The intervention is now being tested in a larger randomized clinical trial. The proposed study will include 192 African American emerging adults with moderate to severe persistent asthma and low controller medication adherence recruited from clinic and emergency department settings. Half of the sample will be randomized to receive a multi-component technology-based intervention (MCTI) targeting adherence to daily controller medication. The MCTI consists of two components: 1) 2 sessions of computer-delivered motivational interviewing targeting medication adherence, and 2) individualized text messaging focused on medication adherence between the sessions. Text messages will be individualized based on Ecological Momentary Assessment (EMA). The remaining half of participants will complete a series of computer-delivered asthma education modules matched for length, location, and method of delivery of the intervention session. Control participants will also receive text messages between intervention sessions. Message content will be the same for all control participants and contain general facts about asthma (not tailored). Youth will be recruited from the Detroit Medical Center, the only university affiliated medical center in Detroit, Michigan. It is hypothesized that youth randomized to MCTI will show improvements in adherence to medication (primary outcome) and asthma control (secondary outcome) compared to the comparison condition at all post-intervention follow ups (3, 6, 9, and 12 months).

Eligibility criteria: Inclusion Criteria:

* African American, moderate to severe persistent asthma requiring daily controller medications, live within 30 miles of study site (Detroit area), be able to complete questionnaires in English, must own or have access to a cell for phone for study duration.

Exclusion Criteria:

* Thought disorder (i.e. schizophrenia, autism), suicidality, or mental retardation, youth with other chronic health conditions or pregnancy requiring ongoing medical intervention (e.g., HIV, Type II Diabetes).

Primary outcomes:
measure: Medication Adherence
timeFrame: Change from baseline at 3, 6, and 12 months
Secondary outcomes:
measure: Asthma Control
timeFrame: Change from baseline at 3, 6, and 12 months
measure: Asthma Control
timeFrame: Change from baseline at 3, 6, and 12 months
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Detroit Medical Center/Wayne State University School of Medicine
state: Michigan
Study officials:
References:
citation: MacDonell K, Naar S, Gibson-Scipio W, Bruzzese JM, Wang B, Brody A. The Detroit Young Adult Asthma Project: Proposal for a Multicomponent Technology Intervention for African American Emerging Adults With Asthma. JMIR Res Protoc. 2018 May 7;7(5):e98. doi: 10.2196/resprot.8872.