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AsthmaDYAAPNCT03121157

Detroit Young Adult Asthma Project

A study testing Multi-Component Technology Based Intervention in people with Asthma, run by Wayne State University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 29 years
Conditions the study is for
Asthma
What is being tested?
Multi-Component Technology Based Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
192 participants
Where
1 siteUnited States
Study dates
10 Apr 2017to 30 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 29 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Detroit Medical Center/Wayne State University School of Medicine

    Detroit, Michigan, 48201

Other trials in United States

About this study

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

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.

Read the 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).

Conditions
Asthma
Being tested
Multi-Component Technology Based Intervention
Keywords
African Americans, Emerging adults, Medication adherence, eHealth
Medical subject headings
Asthma, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multi-Component Technology Based InterventionBehavioural

    Also called The Detroit Young Adult Asthma Project (DYAAP)

    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.

Study groups in NCT03121157
Study groupRoleWhat they receive
InterventionExperimentalThe 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.
Receives: Behavioral: Multi-Component Technology Based Intervention
ControlNo interventionControl 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Medication Adherence

    Daily text messaging, Doser, and self-report

    Measured: Change from baseline at 3, 6, and 12 months

Secondary outcomes (2)
  1. Asthma Control

    Frequency of asthma symptoms based on self-report

    Measured: Change from baseline at 3, 6, and 12 months

  2. Asthma Control

    Lung functioning as measured by portable spirometer

    Measured: Change from baseline at 3, 6, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2017
  2. Study start10 Apr 2017
  3. Primary completion16 Feb 2022
  4. Study completion30 Jun 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
192 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03121157
Sponsor's protocol ID
1R01HL133506-01
Other IDs
R01HL133506
Acronym
DYAAP
Status last verified
May 2022
First submitted
6 Mar 2017
Last updated
9 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29735474

Questions about this trial

What is this clinical trial studying?

A study testing Multi-Component Technology Based Intervention in people with Asthma, run by Wayne State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Medication Adherence (time frame: Change from baseline at 3, 6, and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03121157, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.

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