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AsthmaNCT01714141

Multi-Component Technology Intervention for Minority Emerging Adults With Asthma

A study testing Multi-component, technology based intervention in people with Asthma and Poor Medication Adherence, run by Wayne State University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This pilot study's main goal is to develop and preliminarily test a technology-based intervention to improve asthma medication adherence in urban African American emerging adults (ages 18-29). Read more about this study

Who is it for?
Ages 18 to 29 years
Conditions the study is for
Asthma, Poor Medication Adherence
What is being tested?
Multi-component, technology based intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
No sites listed yet
Study dates
Dec 2011to Sep 2015
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 Live in the Detroit Area, approximately 30 miles from the Hutzel Building Ages 18-29
  • Have moderate to severe persistent asthma. Persistent asthma is defined according to the 2007 NHLBI guidelines. The level of symptoms, as defined by any of the following in the last 4 weeks:
  • Use of any asthma medication more than 2 times a week Daytime asthma symptoms such as wheezing, tightness of chest, problems coughing more than 2 times a week, or waking up at night because of asthma more than 2 times a month
  • Participant is prescribed a daily asthma controller medication, even if they do not take it.
  • Participant must report poor adherence to daily controller medications during eligibility screening (brief interview).
  • Poor adherence is defined as not taking medications "as prescribed" less than 4 days per week in any of the 4 weeks prior to enrollment OR as a proxy of poor adherence as self-report of <80% medication adherence in the past 30 days, self-report of emergency room visit/hospitalization for asthma in the past 6 months, or a poor score on the Asthma Control Test.
  • Participant must be able to complete questionnaires in English Participant must own or have access to a cellular phone for the duration of the study No exclusions will be made due to co-morbid mental health problems (i.e. ADHD, depression) except thought disorders (i.e. schizophrenia, autism), suicidality or mental retardation.

Who cannot join

  • Individuals with other chronic health conditions requiring ongoing medical intervention ( e.g., HIV, Type II Diabetes) will be excluded.
  • These chronic diseases include: Glaucoma, bi-polarism, segmented glomerular nephritis, cystic fibrosis, spondyloarthropathy, congenital heart disease, sickle cell
  • No pregnant women will be included in this study.

About this study

This pilot study's main goal is to develop and preliminarily test a technology-based intervention to improve asthma medication adherence in urban African American emerging adults (ages 18-29). It is hypothesized that youth randomized to MCTI for adherence will show improvements in motivation to adhere to asthma medications and self-reported adherence compared to the comparison condition at 1- and 3- month follow up.

Read the detailed description

This study collected pilot data with a sample of 48 African American emerging adults with asthma with suboptimal medication adherence. Half of the sample were randomized to receive a multi-component technology-based intervention (MCTI) targeting adherence to daily controller medication. The MCTI consisted 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 were individualized based on Ecological Momentary Assessment (EMA). The remaining half of participants completed a series of computer-delivered asthma education modules matched for length, location, and method of delivery of the intervention session. Control participants also received text messages between intervention sessions. Message content was the same for all control participants and contain general facts about asthma (not tailored).

Being tested
Multi-component, technology based intervention, Asthma education active control
Keywords
Technology based intervention, Emerging adults, African Americans, Asthma, Controller medications, Motivational intervention
Medical subject headings
Asthma

What participants receive

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

  • Multi-component, technology based interventionBehavioural

    Motivational sessions were adapted from work done with young adults with HIV (MESA).

  • Asthma education active controlBehavioural

Study groups in NCT01714141
Study groupRoleWhat they receive
Multi-component, technology based interventionExperimental2 tailored, computer-delivered motivational interviewing sessions targeting adherence to asthma control medications + tailored text messaged reminders to take medications between sessions.
Receives: Behavioral: Multi-component, technology based intervention
Asthma education active controlActive comparatorControl condition consists of active control matched to intervention for delivery-method and time-- 2 sessions of computer-delivered asthma education + daily text messaged facts about asthma.
Receives: Behavioral: Asthma education active control

What is being measured

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

  1. Change in medication adherence

    Self-reported adherence to asthma controller medication(s) through questionnaire report and, at baseline and 3 months, 7 days of momentary (real time) sampling of adherence behavior via SMS text messaging.

    Measured: baseline, 1 month, 3 month

  2. Change in motivation for medication adherence

    Self-report of motivation to take asthma controller medications as prescribed.

    Measured: baseline, 1 month, 3 month

Secondary outcomes (7)

  1. Change in asthma knowledge

    Knowledge of asthma and asthma medications

    Measured: baseline, 1 month, 3 month

  2. Change in asthma medication confidence

    Confidence in ability to take asthma medications as prescribed.

    Measured: Baseline, 1 month, 3 month

  3. Change in asthma medication importance

    Perceived importance of taking asthma medication as prescribed.

    Measured: baseline, 1 month, 3 month

  4. Change in asthma control

    Self-reported asthma control (symptom prevalence, health care utilization)

    Measured: baseline, 1 month, 3 month

  5. Change in barriers to taking medication

    Self-report of barriers to taking medication. At baseline and 3 months, daily barriers to taking medications as reported in daily diary.

    Measured: baseline, 1 month, 3 months

  6. Change in asthma anxiety

    Feelings and anxiety associated with living with asthma.

    Measured: baseline, 1 month, 3 month

  7. Change in asthma self-efficacy and attitude

    Self-report of self-efficacy to manage asthma effectively; attitude towards asthma and asthma management.

    Measured: baseline, 1 month, 3 month

Timeline

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

  1. First posted25 Oct 2012 (estimated)
  2. Study startDec 2011
  3. Primary completionSep 2015
  4. Study completionSep 2015

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01714141
Sponsor's protocol ID
MCTI-1R34HL107664-01A1
Status last verified
Oct 2016
First submitted
17 Oct 2012
Last updated
1 Nov 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Kolmodin MacDonell K, Naar S, Gibson-Scipio W, Lam P, Secord E. The Detroit Young Adult Asthma Project: Pilot of a Technology-Based Medication Adherence Intervention for African-American Emerging Adults. J Adolesc Health. 2016 Oct;59(4):465-71. doi: 10.1016/j.jadohealth.2016.05.016. Epub 2016 Jul 27.

    PubMed 27475032

Questions about this trial

What is this clinical trial studying?

A study testing Multi-component, technology based intervention in people with Asthma and Poor Medication Adherence, run by Wayne State University.

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 7 inclusion and 3 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: finished, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in medication adherence (time frame: baseline, 1 month, 3 month). The study lists 2 primary outcomes in all. 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 NCT01714141, 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 1 Nov 2016.

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Clinical Trial NCT01714141 | AzTrials