Multi-Component Technology Intervention for Minority Emerging Adults With Asthma

Asthma Clinical Trial

Official title:

Multi-Component Technology Intervention for Minority Emerging Adults With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01714141
• Other study ID #: MCTI-1R34HL107664-01A1
• Status: Completed
• Phase: N/A
• First received: October 17, 2012
• Last updated: October 31, 2016
• Start date: December 2011
• Est. completion date: September 2015

Study information

• Verified date: October 2016
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States:National Heart, Lung, and Blood Institute- National Institute of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 29 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Poor Medication Adherence

Intervention

Behavioral:
• Multi-component, technology based intervention
Motivational sessions were adapted from work done with young adults with HIV (MESA).
• Asthma education active control

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wayne State University

References & Publications (1)

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: 10.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Change in motivation for medication adherence	Self-report of motivation to take asthma controller medications as prescribed.	baseline, 1 month, 3 month	No
Secondary	Change in asthma knowledge	Knowledge of asthma and asthma medications	baseline, 1 month, 3 month	No
Secondary	Change in asthma medication confidence	Confidence in ability to take asthma medications as prescribed.	Baseline, 1 month, 3 month	No
Secondary	Change in asthma medication importance	Perceived importance of taking asthma medication as prescribed.	baseline, 1 month, 3 month	No
Secondary	Change in asthma control	Self-reported asthma control (symptom prevalence, health care utilization)	baseline, 1 month, 3 month	No
Secondary	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	No
Secondary	Change in asthma anxiety	Feelings and anxiety associated with living with asthma.	baseline, 1 month, 3 month	No
Secondary	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	No