Multi-Component Technology Intervention for Minority Emerging Adults With Asthma

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. Read our disclaimer for details. Identifier: NCT01714141
Recruitment Status : Completed
First Posted : October 25, 2012
Last Update Posted : November 1, 2016
Information provided by (Responsible Party):
Karen MacDonell, PhD, Wayne State University

Brief 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). 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.

Condition or disease Intervention/treatment Phase
Asthma Poor Medication Adherence Behavioral: Multi-component, technology based intervention Behavioral: Asthma education active control Not Applicable

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multi-Component Technology Intervention for Minority Emerging Adults With Asthma
Study Start Date : December 2011
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Multi-component, technology based intervention
2 tailored, computer-delivered motivational interviewing sessions targeting adherence to asthma control medications + tailored text messaged reminders to take medications between sessions.
Behavioral: Multi-component, technology based intervention
Motivational sessions were adapted from work done with young adults with HIV (MESA).
Active Comparator: Asthma education active control
Control 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.
Behavioral: Asthma education active control

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Publications of Results:
Responsible Party: Karen MacDonell, PhD, Assistante Professor, Wayne State University Identifier: NCT01714141     History of Changes
Other Study ID Numbers: MCTI-1R34HL107664-01A1
First Posted: October 25, 2012    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016

Keywords provided by Karen MacDonell, PhD, Wayne State University:
Technology based intervention
Emerging adults
African Americans
Controller medications
Motivational intervention

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