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.

Study Overview

• Status: Completed
• Conditions: Asthma; Poor Medication Adherence
• Intervention / Treatment: Behavioral: Multi-component, technology based intervention; Behavioral: Asthma education active control

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
• Enrollment (Actual): 48
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 29 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

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

Collaborators and Investigators

• Sponsor: Wayne State University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: October 17, 2012
• First Submitted That Met QC Criteria: October 22, 2012
• First Posted (Estimate): October 25, 2012

Study Record Updates

• Last Update Posted (Estimate): November 1, 2016
• Last Update Submitted That Met QC Criteria: October 31, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Asthma; African Americans; Emerging adults; Motivational intervention; Technology based intervention; Controller medications
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: MCTI-1R34HL107664-01A1