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Multi-Component Technology Intervention for Minority Emerging Adults With Asthma

Primary Purpose

Asthma, Poor Medication Adherence

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Multi-component, technology based intervention

Asthma education active control

About this trial

This is an interventional treatment trial for Asthma focused on measuring Technology based intervention, Emerging adults, African Americans, Asthma, Controller medications, Motivational intervention

Eligibility Criteria

18 Years - 29 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multi-component, technology based intervention

Asthma education active control

Arm Description

2 tailored, computer-delivered motivational interviewing sessions targeting adherence to asthma control medications + tailored text messaged reminders to take medications between sessions.

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.

Outcomes

Primary Outcome Measures

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.

Change in motivation for medication adherence

Self-report of motivation to take asthma controller medications as prescribed.

Secondary Outcome Measures

Change in asthma knowledge

Knowledge of asthma and asthma medications

Change in asthma medication confidence

Confidence in ability to take asthma medications as prescribed.

Change in asthma medication importance

Perceived importance of taking asthma medication as prescribed.

Change in asthma control

Self-reported asthma control (symptom prevalence, health care utilization)

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.

Change in asthma anxiety

Feelings and anxiety associated with living with asthma.

Change in asthma self-efficacy and attitude

Self-report of self-efficacy to manage asthma effectively; attitude towards asthma and asthma management.

Full Information

NCT ID

NCT01714141

First Posted

October 17, 2012

Last Updated

October 31, 2016

Sponsor

Wayne State University

1. Study Identification

Unique Protocol Identification Number

NCT01714141

Brief Title

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

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Wayne State University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma, Poor Medication Adherence

Keywords

Technology based intervention, Emerging adults, African Americans, Asthma, Controller medications, Motivational intervention

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Multi-component, technology based intervention

Arm Type

Experimental

Arm Description

2 tailored, computer-delivered motivational interviewing sessions targeting adherence to asthma control medications + tailored text messaged reminders to take medications between sessions.

Arm Title

Asthma education active control

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Multi-component, technology based intervention

Intervention Description

Motivational sessions were adapted from work done with young adults with HIV (MESA).

Intervention Type

Behavioral

Intervention Name(s)

Asthma education active control

Primary Outcome Measure Information:

Title

Change in medication adherence

Description

Time Frame

baseline, 1 month, 3 month

Title

Change in motivation for medication adherence

Description

Self-report of motivation to take asthma controller medications as prescribed.

Time Frame

baseline, 1 month, 3 month

Secondary Outcome Measure Information:

Title

Change in asthma knowledge

Description

Knowledge of asthma and asthma medications

Time Frame

baseline, 1 month, 3 month

Title

Change in asthma medication confidence

Description

Confidence in ability to take asthma medications as prescribed.

Time Frame

Baseline, 1 month, 3 month

Title

Change in asthma medication importance

Description

Perceived importance of taking asthma medication as prescribed.

Time Frame

baseline, 1 month, 3 month

Title

Change in asthma control

Description

Self-reported asthma control (symptom prevalence, health care utilization)

Time Frame

baseline, 1 month, 3 month

Title

Change in barriers to taking medication

Description

Self-report of barriers to taking medication. At baseline and 3 months, daily barriers to taking medications as reported in daily diary.

Time Frame

baseline, 1 month, 3 months

Title

Change in asthma anxiety

Description

Feelings and anxiety associated with living with asthma.

Time Frame

baseline, 1 month, 3 month

Title

Change in asthma self-efficacy and attitude

Description

Self-report of self-efficacy to manage asthma effectively; attitude towards asthma and asthma management.

Time Frame

baseline, 1 month, 3 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

29 Years

Accepts Healthy Volunteers

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.

12. IPD Sharing Statement

Citations:

PubMed Identifier

27475032

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.

Results Reference

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Multi-Component Technology Intervention for Minority Emerging Adults With Asthma

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