Clinical trial NCT01714141: Multi-Component Technology Intervention for Minority Emerging Adults With Asthma
Official title: Multi-Component Technology Intervention for Minority Emerging Adults With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Poor Medication Adherence
Keywords: Technology based intervention
Emerging adults
African Americans
Asthma
Controller medications
Motivational intervention
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2012-10-25
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Change in medication adherence
timeFrame: baseline, 1 month, 3 month
measure: Change in motivation for medication adherence
timeFrame: baseline, 1 month, 3 month
Secondary outcomes:
measure: Change in asthma knowledge
timeFrame: baseline, 1 month, 3 month
measure: Change in asthma medication confidence
timeFrame: Baseline, 1 month, 3 month
measure: Change in asthma medication importance
timeFrame: baseline, 1 month, 3 month
measure: Change in asthma control
timeFrame: baseline, 1 month, 3 month
measure: Change in barriers to taking medication
timeFrame: baseline, 1 month, 3 months
measure: Change in asthma anxiety
timeFrame: baseline, 1 month, 3 month
measure: Change in asthma self-efficacy and attitude
timeFrame: baseline, 1 month, 3 month
Other outcomes:
Locations:
Study officials:
References:
citation: 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.