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Detroit Young Adult Asthma Project (DYAAP)

Primary Purpose

Asthma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multi-Component Technology Based Intervention
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma focused on measuring African Americans, Emerging adults, Medication adherence, eHealth

Eligibility Criteria

18 Years - 29 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Detroit Medical Center/Wayne State University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Medication Adherence
Daily text messaging, Doser, and self-report

Secondary Outcome Measures

Asthma Control
Frequency of asthma symptoms based on self-report
Asthma Control
Lung functioning as measured by portable spirometer

Full Information

First Posted
March 6, 2017
Last Updated
May 5, 2022
Sponsor
Wayne State University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT03121157
Brief Title
Detroit Young Adult Asthma Project
Acronym
DYAAP
Official Title
Multi-component Technology Intervention for African American Emerging Adults With Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 10, 2017 (Actual)
Primary Completion Date
February 16, 2022 (Actual)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
African Americans, Emerging adults, Medication adherence, eHealth

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
192 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Multi-Component Technology Based Intervention
Other Intervention Name(s)
The Detroit Young Adult Asthma Project (DYAAP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Medication Adherence
Description
Daily text messaging, Doser, and self-report
Time Frame
Change from baseline at 3, 6, and 12 months
Secondary Outcome Measure Information:
Title
Asthma Control
Description
Frequency of asthma symptoms based on self-report
Time Frame
Change from baseline at 3, 6, and 12 months
Title
Asthma Control
Description
Lung functioning as measured by portable spirometer
Time Frame
Change from baseline at 3, 6, and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
Detroit Medical Center/Wayne State University School of Medicine
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29735474
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.
Results Reference
derived

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Detroit Young Adult Asthma Project

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