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Completed

NCT Number: NCT01714141

Multi-Component Technology Intervention for Minority Emerging Adults With Asthma

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Multi-component, technology based intervention

Behavioral

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

Asthma education active control

Behavioral

Primary outcomes

  1. Change in medication adherence

    Time frame: baseline, 1 month, 3 month

    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.

  2. Change in motivation for medication adherence

    Time frame: baseline, 1 month, 3 month

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

Secondary outcomes

  1. Change in asthma knowledge

    Time frame: baseline, 1 month, 3 month

    Knowledge of asthma and asthma medications

  2. Change in asthma medication confidence

    Time frame: Baseline, 1 month, 3 month

    Confidence in ability to take asthma medications as prescribed.

  3. Change in asthma medication importance

    Time frame: baseline, 1 month, 3 month

    Perceived importance of taking asthma medication as prescribed.

  4. Change in asthma control

    Time frame: baseline, 1 month, 3 month

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

  5. Change in barriers to taking medication

    Time frame: baseline, 1 month, 3 months

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

  6. Change in asthma anxiety

    Time frame: baseline, 1 month, 3 month

    Feelings and anxiety associated with living with asthma.

  7. Change in asthma self-efficacy and attitude

    Time frame: baseline, 1 month, 3 month

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

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Oct 25, 2012
Registry last updated
Nov 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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