An interventional study of Multi-Component Technology Based Intervention in Asthma, sponsored by Wayne State University. Status unknown at 1 site in United States. Open to participants aged 18 Years to 29 Years. Per ClinicalTrials.gov, last updated 2022-05-09.
Sponsored by Wayne State University · Not applicable, Interventional, and Prevention
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.
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).
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's planned enrollment of 192 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Wayne State University is the lead sponsor of 226 studies on the registry; 35 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
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Exclusion Criteria:
The intervention group will receive two sessions of computer-delivered motivational interviewing via CIAS software programmed to target adherence to medications. The intervention group will also receive text messaged adherence reminders between sessions. Both the computer-delivered sessions and text messages will be tailored to the participant using ecological momentary assessment.
Behavioral: Multi-Component Technology Based Intervention
Control participants complete CIAS-delivered asthma education modules matched for length, location, and method of delivery of the intervention session. Control participants complete each module at their own pace and then complete a short quiz to assess their knowledge. Control participants also receive text messages between intervention sessions. Message content is the same for all control participants and contains general facts about asthma (not tailored). Message timing is not tailored and is sent at the same time every day (4:00 PM--time chosen to avoid AM and PM medication times but to not interfere with sleep and school activities).
The intervention group receives two sessions of computer-delivered MI via software programmed to target adherence to medications and text messaged adherence reminders between sessions. Sessions are provided by an avatar. The intervention engages the youth with the avatar's communication of empathy, optimism, and autonomy support. The intervention focuses the youth on adherence and relevant health behaviors with feedback on adherence, asthma symptoms, and tailored education. Participants are guided in the planning process through goal setting activities. The length of the intervention sessions are about 30 minutes each, with the total duration of the visit (assessment and intervention) lasting about 1.5 hours.
Also known as: The Detroit Young Adult Asthma Project (DYAAP)
Medication Adherence
Daily text messaging, Doser, and self-report
Time frame: Change from baseline at 3, 6, and 12 months
Asthma Control
Frequency of asthma symptoms based on self-report
Time frame: Change from baseline at 3, 6, and 12 months
Asthma Control
Lung functioning as measured by portable spirometer
Time frame: Change from baseline at 3, 6, and 12 months
Plan to share: No
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Wayne State University