Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Detroit Young Adult Asthma Project (DYAAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03121157
Recruitment Status : Recruiting
First Posted : April 20, 2017
Last Update Posted : December 13, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Karen MacDonell, PhD, Wayne State University

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.

Condition or disease Intervention/treatment Phase
Asthma Behavioral: Multi-Component Technology Based Intervention Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Multi-component Technology Intervention for African American Emerging Adults With Asthma
Actual Study Start Date : April 10, 2017
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
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
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.
Other Name: The Detroit Young Adult Asthma Project (DYAAP)

No Intervention: Control
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).



Primary Outcome Measures :
  1. Medication Adherence [ Time Frame: Change from baseline at 3, 6, and 12 months ]
    Daily text messaging, Doser, and self-report


Secondary Outcome Measures :
  1. Asthma Control [ Time Frame: Change from baseline at 3, 6, and 12 months ]
    Frequency of asthma symptoms based on self-report

  2. Asthma Control [ Time Frame: Change from baseline at 3, 6, and 12 months ]
    Lung functioning as measured by portable spirometer



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03121157


Contacts
Layout table for location contacts
Contact: Karen MacDonell, Ph.D. (313) 577 - 6996 karen.macdonell@wayne.edu
Contact: Jessica Durkin, M.Ed. (313) 577-6583 jwalke@med.wayne.edu

Locations
Layout table for location information
United States, Michigan
Detroit Medical Center/Wayne State University School of Medicine Recruiting
Detroit, Michigan, United States, 48201
Contact: Regulatory Coordinator    313-745-4414      
Sponsors and Collaborators
Wayne State University
National Heart, Lung, and Blood Institute (NHLBI)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Karen MacDonell, PhD, Principal Investigator, Wayne State University
ClinicalTrials.gov Identifier: NCT03121157     History of Changes
Other Study ID Numbers: 1R01HL133506-01 ( U.S. NIH Grant/Contract )
R01HL133506 ( U.S. NIH Grant/Contract )
First Posted: April 20, 2017    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Karen MacDonell, PhD, Wayne State University:
African Americans
Emerging adults
Medication adherence
eHealth

Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases