NCT03121157

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
192

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

April 10, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 20, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

May 9, 2022

Status Verified

May 1, 2022

Enrollment Period

4.9 years

First QC Date

March 6, 2017

Last Update Submit

May 5, 2022

Conditions

Asthma

Keywords

African AmericansEmerging adultsMedication adherenceeHealth

Outcome Measures

Primary Outcomes (1)

  • Medication Adherence

    Daily text messaging, Doser, and self-report

    Change from baseline at 3, 6, and 12 months

Secondary Outcomes (2)

  • Asthma Control

    Change from baseline at 3, 6, and 12 months

  • Asthma Control

    Change from baseline at 3, 6, and 12 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

NO 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).

Interventions

Multi-Component Technology Based InterventionBEHAVIORAL

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)
Intervention

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Detroit Medical Center/Wayne State University School of Medicine

Detroit, Michigan, 48201, United States

Location

Related Publications (1)

  • 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.

    PMID: 29735474DERIVED

MeSH Terms

Conditions

AsthmaMedication Adherence

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 6, 2017

First Posted

April 20, 2017

Study Start

April 10, 2017

Primary Completion

February 16, 2022

Study Completion

June 30, 2022

Last Updated

May 9, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)