Multi-Component Technology Intervention for Minority Emerging Adults With Asthma

Study Overview
=================
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.

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).

Official Title
-----------------
Multi-Component Technology Intervention for Minority Emerging Adults With Asthma

Conditions
-----------------
Asthma, Poor Medication Adherence

Intervention / Treatment
-----------------
* Behavioral: Multi-component, technology based intervention
* Behavioral: Asthma education active control


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 29 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multi-component, technology based intervention<br>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<br>* Motivational sessions were adapted from work done with young adults with HIV (MESA).<br>|
| Active Comparator: Asthma education active control<br>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<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline, 1 month, 3 month | 
| Change in motivation for medication adherence | Self-report of motivation to take asthma controller medications as prescribed. | baseline, 1 month, 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in asthma knowledge | Knowledge of asthma and asthma medications | baseline, 1 month, 3 month | 
| Change in asthma medication confidence | Confidence in ability to take asthma medications as prescribed. | Baseline, 1 month, 3 month | 
| Change in asthma medication importance | Perceived importance of taking asthma medication as prescribed. | baseline, 1 month, 3 month | 
| Change in asthma control | Self-reported asthma control (symptom prevalence, health care utilization) | baseline, 1 month, 3 month | 
| 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. | baseline, 1 month, 3 months | 
| Change in asthma anxiety | Feelings and anxiety associated with living with asthma. | baseline, 1 month, 3 month | 
| Change in asthma self-efficacy and attitude | Self-report of self-efficacy to manage asthma effectively; attitude towards asthma and asthma management. | baseline, 1 month, 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Technology based intervention, Emerging adults, African Americans, Asthma, Controller medications, Motivational intervention