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Asthma and Technology in Emerging African American Adults (ATHENA)

Primary Purpose

Asthma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Enhancement System (MES)
Supportive Accountability (SA)
Text Messaging (SMS)
Physical Activity Tracking (PAT)
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma focused on measuring African American, Young Adult, eHealth, Mobile Health

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • African American, 18-30 years of age, uncontrolled asthma (defined by a score of less than 19 on the ACT), own or have access to a cell phone for the duration of the study, have a primary care physician (PCP)

Exclusion Criteria:

  • Significant cardiopulmonary disease (including chronic obstructive pulmonary disease), a greater than 20 pack per year smoking history, developmental delay or mental illness such that participation in the program would not be possible, pregnancy

Sites / Locations

  • Florida State University
  • University of MichiganRecruiting
  • Wayne State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

No Intervention

Arm Label

Motivational Enhancement System (MES) and Physical Activity Tracking (PAT)

Supportive Accountability (SA) and PAT

Text Messaging (SMS) and PAT

MES_SMS_PAT

SA_SMS_PAT

Usual Care_PAT

Arm Description

MES is a web-based, mobile asthma management intervention delivered to participants' personal mobile devices. There are 4 sessions, completed over 10 weeks, with each session taking approximately 15-20 minutes. During Session 1, participants will identify asthma-related problems they may encounter and will receive asthma information and motivation. Between Session 1 and Session 2, participants will be asked to complete an electronic daily diary for 7 days. Session 2 allows participants to select up to 2 goals to address. Session 3 occurs over the course of 4 weeks and provides tailored messages based on problem and goal selection. The final session (Session 4), asks participants for feedback on how well they feel they accomplished their goal. Additionally, participants will be asked to track their daily and weekly step totals as well their total minutes of moderate to vigorous physical activity using a wearable activity tracker provided by the study.

SA is an asthma management intervention delivered by asthma nurses trained in targeted MI skills (e.g., open-ended questions around change talk, affirmations) via participants' personal mobile devices (e.g., Skype, FaceTime, voice calls, and SMS). Sessions with the nurse will be approximately 15-20 minutes in length and will focus on ways to improve asthma care. There are 4 sessions with the nurse, over the course of 10 weeks. Additionally, participants will be asked to track their daily and weekly step totals as well their total minutes of moderate to vigorous physical activity using a wearable activity tracker provided by the study.

SMS will target asthma knowledge. One-way SMS messages will be sent to participants' personal mobile devices with facts about asthma management, links to educational web content, and videos providing information about living with asthma. Text messages will be sent twice a week for the first 5 weeks and once a week for the last 5 weeks. Additionally, participants will be asked to track their daily and weekly step totals as well their total minutes of moderate to vigorous physical activity using a wearable activity tracker provided by the study.

Participants will receive a combination of the MES and SMS interventions. Additionally, participants will be asked to track their daily and weekly step totals as well their total minutes of moderate to vigorous physical activity using a wearable activity tracker provided by the study.

Participants will receive a combination of the SA and SMS interventions. Additionally, participants will be asked to track their daily and weekly step totals as well their total minutes of moderate to vigorous physical activity using a wearable activity tracker provided by the study.

Participants will continue to receive standard clinical asthma care. Additionally, participants will be asked to track their daily and weekly step totals as well their total minutes of moderate to vigorous physical activity using a wearable activity tracker provided by the study.

Outcomes

Primary Outcome Measures

Asthma Control Test (ACT)
Frequency of asthma symptoms based on self-report

Secondary Outcome Measures

Asthma Quality of Life Questionnaire (AQLQ)
Measures functional impairments that are most troublesome to adults with asthma
Asthma exacerbations
Reduction in number of asthma exacerbations
Medication Adherence Report Scale for Asthma (MARS-A)
Self reported adherence to asthma controller medication
International Physical Activity Questionnaire (IPAQ)
Assess kinds of physical activities and time spent being physically active

Full Information

First Posted
April 14, 2022
Last Updated
August 11, 2023
Sponsor
University of Michigan
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT05445583
Brief Title
Asthma and Technology in Emerging African American Adults
Acronym
ATHENA
Official Title
Asthma and Technology in Emerging African American Adults (The ATHENA Project).
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the ATHENA Project is to test a mobile health intervention to help African American young adults better manage their asthma. The program has four components: 1) a web-based, mobile asthma program delivered to participants' mobile device, 2) meetings with an asthma nurse via video conference, 3) text messaging, and 4) physical activity tracking. Participants will be randomly assigned to one or more of these components to better meet the needs of young adults with asthma.
Detailed Description
Asthma causes substantial morbidity and mortality in the United States, particularly among African American emerging adults (AAEA; ages 18-30), but very few asthma programs have targeted this population. Interventions that provide education and address underlying motivation for managing asthma may be most effective. However, face-to-face interventions are often difficult to implement, especially among emerging adults. Mobile asthma management interventions may help improve asthma control and allow people to live healthier lives. During this project, the research team will use an innovative strategy to develop a mobile asthma management intervention using the most effective combination of a smart phone app delivering personalized asthma information (MES), nurse-delivered asthma education (SA), text messaging (SMS), and physical activity tracking (PAT). The purpose of this proposal is to develop an effective mHealth intervention to improve asthma management and asthma control in AAEA. Investigators will assess the ability of multiple technologic components to assist and improve traditional asthma education. Upon completion of the study, investigators will have an empirically-supported mobile asthma management intervention to improve asthma control for AAEA. It is hypothesized that post-intervention, participants with uncontrolled asthma will show clinically-significant improvement in asthma control and improvements in asthma management behaviors, quality of life, symptoms, adherence, and exacerbations will also be observed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
African American, Young Adult, eHealth, Mobile Health

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Motivational Enhancement System (MES) and Physical Activity Tracking (PAT)
Arm Type
Experimental
Arm Description
MES is a web-based, mobile asthma management intervention delivered to participants' personal mobile devices. There are 4 sessions, completed over 10 weeks, with each session taking approximately 15-20 minutes. During Session 1, participants will identify asthma-related problems they may encounter and will receive asthma information and motivation. Between Session 1 and Session 2, participants will be asked to complete an electronic daily diary for 7 days. Session 2 allows participants to select up to 2 goals to address. Session 3 occurs over the course of 4 weeks and provides tailored messages based on problem and goal selection. The final session (Session 4), asks participants for feedback on how well they feel they accomplished their goal. Additionally, participants will be asked to track their daily and weekly step totals as well their total minutes of moderate to vigorous physical activity using a wearable activity tracker provided by the study.
Arm Title
Supportive Accountability (SA) and PAT
Arm Type
Experimental
Arm Description
SA is an asthma management intervention delivered by asthma nurses trained in targeted MI skills (e.g., open-ended questions around change talk, affirmations) via participants' personal mobile devices (e.g., Skype, FaceTime, voice calls, and SMS). Sessions with the nurse will be approximately 15-20 minutes in length and will focus on ways to improve asthma care. There are 4 sessions with the nurse, over the course of 10 weeks. Additionally, participants will be asked to track their daily and weekly step totals as well their total minutes of moderate to vigorous physical activity using a wearable activity tracker provided by the study.
Arm Title
Text Messaging (SMS) and PAT
Arm Type
Experimental
Arm Description
SMS will target asthma knowledge. One-way SMS messages will be sent to participants' personal mobile devices with facts about asthma management, links to educational web content, and videos providing information about living with asthma. Text messages will be sent twice a week for the first 5 weeks and once a week for the last 5 weeks. Additionally, participants will be asked to track their daily and weekly step totals as well their total minutes of moderate to vigorous physical activity using a wearable activity tracker provided by the study.
Arm Title
MES_SMS_PAT
Arm Type
Experimental
Arm Description
Participants will receive a combination of the MES and SMS interventions. Additionally, participants will be asked to track their daily and weekly step totals as well their total minutes of moderate to vigorous physical activity using a wearable activity tracker provided by the study.
Arm Title
SA_SMS_PAT
Arm Type
Experimental
Arm Description
Participants will receive a combination of the SA and SMS interventions. Additionally, participants will be asked to track their daily and weekly step totals as well their total minutes of moderate to vigorous physical activity using a wearable activity tracker provided by the study.
Arm Title
Usual Care_PAT
Arm Type
No Intervention
Arm Description
Participants will continue to receive standard clinical asthma care. Additionally, participants will be asked to track their daily and weekly step totals as well their total minutes of moderate to vigorous physical activity using a wearable activity tracker provided by the study.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Enhancement System (MES)
Intervention Description
MES is an eHealth application and focuses on asthma management behaviors with feedback on asthma symptoms, physical activity, adherence, and tailored education. The program is interactive and tailored to each participant by (1) allowing participants to choose barriers/goals related to their asthma care and (2) by sending personalized feedback based on participant daily diary responses. MES consists of 4 sessions delivered over the course of 10 weeks within 10 smaller 5-10 minute blocks.
Intervention Type
Behavioral
Intervention Name(s)
Supportive Accountability (SA)
Intervention Description
Supportive accountability (SA) is an asthma management intervention delivered by asthma nurses trained in motivational interviewing skills (e.g., open-ended questions around change talk, affirmations) via participants' personal mobile devices (e.g., Skype, FaceTime, voice calls, and SMS). The theory underlying SA is that education and behavior change are most impactful when delivered by a knowledgeable yet supportive authority figure (i.e. nurse).
Intervention Type
Behavioral
Intervention Name(s)
Text Messaging (SMS)
Intervention Description
SMS will target asthma knowledge. SMS messages will be sent via CIAS 3.0 to participants' personal mobile devices with facts about asthma management, links to educational web content, and videos providing information about living with asthma. Information covered includes 'What is asthma,' 'What is an asthma attack,' 'What causes an asthma attack,' 'How is asthma treated,' 'Asthma and weather,' 'Using an inhaler,' 'Using a spacer,' and 'Asthma Action Plans.'
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity Tracking (PAT)
Intervention Description
All participants will be provided a wearable physical activity tracking device, which will allow them to accurately track exercise and total steps each day. Through PAT, users will be able to set daily goals and attain motivation to continue asthma management. For individuals randomized to groups that also include MES or SA, those programs will incorporate PAT data that is remotely transmitted, to facilitate asthma management motivation.
Primary Outcome Measure Information:
Title
Asthma Control Test (ACT)
Description
Frequency of asthma symptoms based on self-report
Time Frame
Change from baseline at 3, 6, and 12 months
Secondary Outcome Measure Information:
Title
Asthma Quality of Life Questionnaire (AQLQ)
Description
Measures functional impairments that are most troublesome to adults with asthma
Time Frame
Change from baseline at 3, 6, and 12 months
Title
Asthma exacerbations
Description
Reduction in number of asthma exacerbations
Time Frame
Change from baseline at 3, 6, and 12 months
Title
Medication Adherence Report Scale for Asthma (MARS-A)
Description
Self reported adherence to asthma controller medication
Time Frame
Change from baseline at 3, 6, and 12 months
Title
International Physical Activity Questionnaire (IPAQ)
Description
Assess kinds of physical activities and time spent being physically active
Time Frame
Change from baseline at 3, 6, and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: African American, 18-30 years of age, uncontrolled asthma (defined by a score of less than 19 on the ACT), own or have access to a cell phone for the duration of the study, have a primary care physician (PCP) Exclusion Criteria: Significant cardiopulmonary disease (including chronic obstructive pulmonary disease), a greater than 20 pack per year smoking history, developmental delay or mental illness such that participation in the program would not be possible, pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alan Baptist, MD.
Phone
734-936-5634
Email
abaptist@med.umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Muzhda Hashmi, BS
Phone
734-232-6868
Email
hashmim@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Baptist, MD.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida State University
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen MacDonell, Ph.D
Email
karen.macdonell@med.fsu.edu
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alan Baptist, MD
First Name & Middle Initial & Last Name & Degree
Alan Baptist, MD
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
April Carcone
Email
acarcone@med.wayne.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Asthma and Technology in Emerging African American Adults

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