NCT01714141

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable asthma

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 25, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

3.8 years

First QC Date

October 17, 2012

Last Update Submit

October 31, 2016

Conditions

Keywords

Technology based interventionEmerging adultsAfrican AmericansAsthmaController medicationsMotivational intervention

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • Change in asthma knowledge

    baseline, 1 month, 3 month

  • Change in asthma medication confidence

    Baseline, 1 month, 3 month

  • Change in asthma medication importance

    baseline, 1 month, 3 month

  • Change in asthma control

    baseline, 1 month, 3 month

  • Change in barriers to taking medication

    baseline, 1 month, 3 months

  • +2 more secondary outcomes

Study Arms (2)

Multi-component, technology based intervention

EXPERIMENTAL

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

Asthma education active control

ACTIVE COMPARATOR

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

Interventions

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

Multi-component, technology based intervention
Asthma education active control

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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: 10.1016/j.jadohealth.2016.05.016. Epub 2016 Jul 27.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistante Professor

Study Record Dates

First Submitted

October 17, 2012

First Posted

October 25, 2012

Study Start

December 1, 2011

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

November 1, 2016

Record last verified: 2016-10