Detroit Young Adult Asthma Project

Asthma Clinical Trial

— DYAAP  

Official title:

Multi-component Technology Intervention for African American Emerging Adults With Asthma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03121157
• Other study ID #: 1R01HL133506-01
• Secondary ID: R01HL133506
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 10, 2017
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2022
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 192
• Est. completion date: June 30, 2022
• Est. primary completion date: February 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

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).

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• Multi-Component Technology Based Intervention
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.

Locations

Country	Name	City	State
United States	Detroit Medical Center/Wayne State University School of Medicine	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Wayne State University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Adherence	Daily text messaging, Doser, and self-report	Change from baseline at 3, 6, and 12 months
Secondary	Asthma Control	Frequency of asthma symptoms based on self-report	Change from baseline at 3, 6, and 12 months
Secondary	Asthma Control	Lung functioning as measured by portable spirometer	Change from baseline at 3, 6, and 12 months