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Multi-Component Technology Intervention for Minority Emerging Adults With Asthma

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Karen MacDonell, PhD, Wayne State University
ClinicalTrials.gov Identifier:
NCT01714141
First received: October 17, 2012
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Asthma
Poor Medication Adherence
Behavioral: Multi-component, technology based intervention
Behavioral: Asthma education active control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Multi-Component Technology Intervention for Minority Emerging Adults With Asthma

Further study details as provided by Wayne State University:

Primary Outcome Measures:
  • Change in medication adherence [ Time Frame: baseline, 1 month, 3 month ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline, 1 month, 3 month ] [ Designated as safety issue: No ]
    Self-report of motivation to take asthma controller medications as prescribed.


Secondary Outcome Measures:
  • Change in asthma knowledge [ Time Frame: baseline, 1 month, 3 month ] [ Designated as safety issue: No ]
    Knowledge of asthma and asthma medications

  • Change in asthma medication confidence [ Time Frame: Baseline, 1 month, 3 month ] [ Designated as safety issue: No ]
    Confidence in ability to take asthma medications as prescribed.

  • Change in asthma medication importance [ Time Frame: baseline, 1 month, 3 month ] [ Designated as safety issue: No ]
    Perceived importance of taking asthma medication as prescribed.

  • Change in asthma control [ Time Frame: baseline, 1 month, 3 month ] [ Designated as safety issue: No ]
    Self-reported asthma control (symptom prevalence, health care utilization)

  • Change in barriers to taking medication [ Time Frame: baseline, 1 month, 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline, 1 month, 3 month ] [ Designated as safety issue: No ]
    Feelings and anxiety associated with living with asthma.

  • Change in asthma self-efficacy and attitude [ Time Frame: baseline, 1 month, 3 month ] [ Designated as safety issue: No ]
    Self-report of self-efficacy to manage asthma effectively; attitude towards asthma and asthma management.


Estimated Enrollment: 80
Study Start Date: December 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

This study is collecting pilot data with a sample of 80 African American emerging adults with asthma with suboptimal medication adherence. Half of the sample are randomized to receive a multi-component technology-based intervention (MCTI) targeting adherence to daily controller medication. The MCTI consists 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 are individualized based on Ecological Momentary Assessment (EMA). The remaining half of participants complete a series of computer-delivered asthma education modules matched for length, location, and method of delivery of the intervention session. Control participants also receive text messages between intervention sessions. Message content is the same for all control participants and contain general facts about asthma (not tailored).

  Eligibility

Ages Eligible for Study:   18 Years to 29 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Karen MacDonell, PhD, Assistante Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT01714141     History of Changes
Other Study ID Numbers: MCTI-1R34HL107664-01A1
Study First Received: October 17, 2012
Last Updated: June 2, 2014
Health Authority: United States:National Heart, Lung, and Blood Institute- National Institute of Health

Keywords provided by Wayne State University:
Technology based intervention
Emerging adults
African Americans
Asthma
Controller medications
Motivational intervention

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 20, 2014