ACTION: physicAl aCtiviTy In minOrity womeN With Asthma Intervention
Phase: NA
Conditions: Asthma
Sponsor: University of Illinois at Chicago

 
 
 
  
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ACTION (physicAl aCtiviTy In minOrity womeN with asthma) intervention 
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Principal Investigator: 
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[Sharmilee Nyenhuis, MD FAAAAI 
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Assistant Professor Medicine 
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University of Illinois at Chicago, 
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840 S. Wood St. MC 719 Chicago, IL 60612 
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312-413-1655, snyenhui@uic.edu] 
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Co-Investigators: 
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Lisa Sharp, PhD 
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Associate Professor of Pharmacy 
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University of Illinois at Chicago 
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1747 West Roosevelt Road MC 275 Chicago, IL 60608 
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312-355-3569, sharpl@uic.edu 
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David Marquez, PhD 
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Associate Professor of Kinesiology 
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University of Illinois at Chicago 
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632 Applied Health Sciences Bldg., 1919 W. Taylor Street, Chicago, IL 60612 
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312- 996-1209, marquezd@uic.edu 
23 
 JoEllen Wilbur, PhD APN 
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Associate Dean of Research, Professor of Nursing 
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Rush University, College of Nursing 
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600 S. Paulina St. Suite 1062A Chicago, IL 60612 
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312-942-8947 joellen_wilbur@rush.edu 
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Spyros Kitsiou, PhD 
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Assistant Professor of Biomedical and Health Information Sciences 
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632 Applied Health Sciences Bldg., MC 530 1919 W. Taylor Street, Chicago, IL 60612 
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University of Illinois at Chicago 
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312-355-3519, skitsiou@uic.edu 
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Study Location(s):  
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1. University Illinois at Chicago 
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2. Chicago Park District  
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541 N Fairbanks Ct, Chicago, IL 60611 
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Sponsor: [National Heart, Lung and Blood Institute, Central Society of Clinical and 
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Translational Research] 
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Version: [20] 
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Date: [April 23rd, 2021] 
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[The Table of Contents can be updated by going to the “References” menu in the 
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toolbar, then “Update Table”.] 
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TABLE OF CONTENTS 
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Page 
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Table of Contents ................................................................................................................ 3 
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List of Abbreviations ............................................................................................................ 4 
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1.0 Project Summary/Abstract ...................................................................................... 5 
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2.0 Background/Scientific Rationale ............................................................................ 6 
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3.0 Objectives/Aims ........................................................................................................ 6 
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4.0 Eligibility ..................................................................................................................... 8 
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4.1 Inclusion Criteria ................................................................................................. 8 
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4.2 Exclusion Criteria................................................................................................ 8 
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4.3 Excluded or Vulnerable Populations ................................................................ 9 
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5.0 Subject Enrollment ................................................................................................. 10 
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6.0 Study Design and Procedures............................................................................... 11 
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7.0 Expected Risks/Benefits ........................................................................................ 23 
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8.0 Data Collection and Management Procedures .................................................... 24 
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9.0 Data Analysis/Quality Control ............................................................................... 25 
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10.0 Data and Safety Monitoring ................................................................................... 26 
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11.0 Statistical Considerations ...................................................................................... 28 
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12.0 Regulatory Requirements ...................................................................................... 28 
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12.1 
Informed Consent ........................................................................................ 28 
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12.2 
Subject Confidentiality ................................................................................ 30 
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12.3 
Unanticipated Problems .............................................................................. 30 
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13.0 References ............................................................................................................... 31 
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Appendices ........................................................................................................................ 32 
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LIST OF ABBREVIATIONS  
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AA 
 
 
African American 
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ACQ  
 
Asthma Control Questionnaire 
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ACTION 
 
physicAl aCtiviTy In minOrity womeN with asthma 
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DSMP  
 
Data and Safety Monitoring Plan 
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EHR  
 
Electronic Health Record 
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HIPAA 
 
Health Insurance Portability and Accountability Act 
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IRB 
 
 
Institutional Review Board 
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ISWT  
 
Incremental Shuttle Walk Test 
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NIH 
 
 
National Institutes of Health 
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OPRS  
 
Office for the Protection of Research Subjects 
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PA 
 
 
Physical Activity 
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PHI 
 
 
Protected Health Information 
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PI 
 
 
Principal Investigator 
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SAE  
 
Serious Adverse Event 
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1.0 
Project Summary/Abstract 
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Physical inactivity in asthma is associated with worse asthma outcomes and African 
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American women are disproportionately impacted by both physical inactivity and 
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asthma. Research aimed at addressing the unique asthma-related and cultural-specific 
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barriers to physical activity in this vulnerable population of women is needed. The 
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proposed study will modify a validated community-based walking intervention specific to 
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the needs of sedentary African American women with asthma and evaluate the impact 
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of the intervention on physical activity and asthma specific indicators to reduce the 
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burden of asthma in sedentary African American women.  
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2.0 
Background/Scientific Rationale  
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Asthma is a highly prevalent chronic disease that disproportionately impacts African 
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American (AA) women. AA women have poorer asthma-related quality of life and higher 
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rates of asthma exacerbations, healthcare utilization and mortality compared to 
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Caucasian women. Further, AA women are less physically active than any other 
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subgroup of adults, which may help explain the asthma health disparities, found 
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between AA and Caucasian women. Physical inactivity among individuals with asthma 
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is associated with poor asthma control and respiratory function, greater health care 
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utilization, and poorer quality of life. Given the connection between poor asthma 
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outcomes and physical inactivity, addressing physical activity (PA) among sedentary AA 
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women with asthma is imperative. Physical activity demonstrated improvement in 
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asthma outcomes specifically asthma control, quality of life and healthcare utilization. 
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Despite these benefits, fewer than 25% of AA women with asthma engage in regular 
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physical activity. The ACTION intervention: physicAl aCtiviTy In minOrity womeN 
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with asthma is a 8-month community-based walking intervention refined to be 
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applicable for sedentary AA women with asthma.  
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This project will obtain and incorporate stakeholder input on the barriers and facilitators 
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to engaging in physical activity with asthma to a validated community-based walking 
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intervention. Once modified, we will pre-pilot the intervention in 10 participants, refine 
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further in response to participant feedback and then test the feasibility, acceptability and 
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estimate the efficacy of the intervention in a randomized controlled pilot of 80 
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participants within a pragmatic community setting convenient for sedentary AA women.  
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3.0 
Objectives/Aims 
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The proposed study has 5 aims involving a total of 135 sedentary AA women with 
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asthma.  
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NOTE: Aims 1 and 2 have been IRB approved and completed. Only data analysis of 
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these 2 aims are still occurring. At this time, I am requesting approval for Aim 3 which 
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entails pilot testing the intervention to assess the feasibility, acceptability and to 
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estimate the efficacy of the ACTION intervention.  
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Aim 1: Use stakeholder input to modify a validated walking intervention for sedentary 
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AA women with asthma. 
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Aim 1a: Conduct focus groups in 30 sedentary AA women with asthma to assess PA 
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barriers and facilitators. 
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Aim 1b: Adapt a validated walking intervention that addresses the barriers and 
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facilitators to PA unique to sedentary AA women with asthma obtained from Aim 1A. 
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Aim 2: Pre-pilot test ACTION (physicAl aCtiviTy In minOrity womeN with asthma) 
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intervention in up to 10 sedentary AA women with asthma to refine the recruitment 
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materials, approach, design, and intervention content.  
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Aim 3: Pilot test ACTION intervention in 80 sedentary AA women with asthma to 
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assess acceptability, feasibility and estimate the efficacy to appropriately power a 
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subsequent efficacy trial.  
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Aim 4: Modify and refine the video component of the intervention to address the 
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asthma-specific barriers to walking in AA women with asthma.  
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Aim 4a: Conduct a focus group with an Asthma Advisory Council (AAC) that includes up 
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to 15 AA women with asthma, to assess the appropriateness of the proposed asthma 
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content, language and setting used in the videos.   
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Aim 4b: Adapt the video component of the intervention using an iterative approach to 
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include appropriate asthma content, language and setting.  
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Aim 5: Assess the acceptability of the revised videos by the AAC using a mixed 
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methods approach (qualitative and quantitative data).  
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Aim 6: Disseminate research findings and next steps to women that participated in 
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Aims 1-3.  
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V=Visit; *=Data collection; 
          UIC=University of Illinois at Chicago;  CPD= Chicago Park District 
 
 V4*       
 
Recruitment 
& Eligibility 
(phone) 
ACTION Trial 
Intervention 
(CPD or UIC) 
Baseline 
interview & 
data collection 
(UIC) 
 
 
Figure 1. Study Design for ACTION Pre-pilot 
     V0 
V1* 
V2 
V3 
-2 
0 
1-2  4 
 6       
weeks 
V=Visit; CPD= Chicago Park District; *=Data collection time points  
Adoption                      Maintenance 
Recruitment & 
Eligibility (phone) 
Enhanced Usual Care  
8 months 
ACTION Trial 
Intervention (CPD) 
8 months 
Baseline interview and collection 
of measures  
(Healthcare setting) 
 
Post-intervention 
measures 
collection 
(Healthcare 
setting) 
Asthma 
Education and 
PA Session 
(CPD) 
 
Randomization (Visit 1) 
Figure 2. Study Design for Aim 3 (ACTION RCT Pilot) 
V0 
V1* 
V2 
V3 
-2 
0 
1-6 
    8     12    16    20   24                                         36          
weeks 
V4   V5    V6   V7a/b*   
        V8* 

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4.0 
Eligibility/Inclusion and Exclusion Criteria (for Aims 1, 2 and 3) 
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Participants will be recruited from the UI Health System.  
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• Eligibility considerations: We chose to focus on sedentary AA women with 
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sub-optimally controlled persistent asthma  (based on ACQ score 1.5/Appendix 
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1 OR ACT score 20/Appendix 2) as long-term goal is to see an effect change in 
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asthma control. During our focus groups, we will discuss if there is a preferred 
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age range and will refine the intervention accordingly. Focus group participants 
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did not express a preferred age range so a diverse age range of participants will 
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be recruited to ensure representation from a diverse population of AA women 
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with asthma. Women that have completed participation in Aims 1, 2, or 3 of this 
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study will be able to participate in Aims 4 and 5 of the study.  
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4.1 Inclusion Criteria  
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4.1.a. Aims 1 and 2: 
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• Self-identify as female and black or AA 
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• Age 18-70 
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• Self-report <150 min/week of moderate intensity PA 
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• Sub-optimally controlled persistent asthma based on Asthma Control 
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Questionnaire (ACQ 1.5) OR Asthma Control Test (ACT <20) 
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• Wiling to enroll and provide written-informed consent  
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4.1.b. Aim 3 
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• Self-identify as female and black or AA 
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• Age 18-70 
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• Sub-optimally controlled persistent asthma based on Asthma Control Test (ACT 
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<20) 
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• Wiling to enroll and provide written-informed consent 
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• Have a smartphone or tablet device 
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• Willing to be randomly assigned to treatment or control group 
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4.1.c. Aims 4 and 5 
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• Self-identify as female and black or AA 
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• Age 18-70 
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• Wiling to enroll and provide written-informed consent 
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4.2 Exclusion Criteria: 
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4.2.a. Aims 1 and 2 
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• Plans to move from Chicago during the study period 
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• Unable to ambulate without human assistance 
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• History of significant mental illness (e.g. uncontrolled bipolar disorder, 
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psychoses) 
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• Currently pregnant, planning to become pregnant over the next 3 months 
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• Diagnosis of COPD (emphysema or chronic bronchitis) suggested by patient 
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report of doctor diagnosis or smoking history (>20 pack years) 
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• Family/household member of another study participant or staff member 
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• 
Inability to speak, read or understand English; 
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• Investigator discretion for safety or protocol adherence reasons 
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4.2.b. Aim 3 
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• Plans to relocate outside of the Chicagoland area during the study period. 
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• Unable to ambulate without human assistance (ie. use of a wheelchair, scooter) 
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• History of significant mental illness (e.g. uncontrolled bipolar disorder, 
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psychoses) 
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• Currently pregnant, planning to become pregnant over the next 3 months 
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• Diagnosis of COPD (emphysema or chronic bronchitis) suggested by patient 
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report of doctor diagnosis or smoking history (>20 pack years) 
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• Poorly controlled high blood pressure (BP >180/100 at baseline visit) 
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• Family/household member of another study participant or staff member 
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• Inability to speak, read or understand English; 
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• Investigator discretion for safety or protocol adherence reasons 
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• Participation in Aim 2 of this study 
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We will use the Exercise Assessment and Screening for You (EASY) questionnaire 
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(Appendix 3 to detect the presence of conditions that could preclude study participation. 
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Current physical activity (PA) screening guidelines from a consensus group from the 
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American Heart Association and the American College of Cardiology no longer 
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recommend routine stress testing for those initiating a PA program. The EASY 
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questionnaire has clear recommendations for when evaluation by a physician is needed 
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before beginning a PA program (e.g., when the individual reports new-onset shortness 
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of breath, pain, or dizziness that has not been previously evaluated by a health care 
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provider), and we will follow these recommendations.  
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If the EASY questionnaire recommends that a potential participant be evaluated by a 
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health care provider prior to starting a PA program, the potential participant will be 
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asked to contact their health care provider or we will obtain permission from the 
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participant to contact their UI Health provider. We will send their UI Health provider a 
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secure message describing the study and it’s procedures and the results of their 
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patient’s EASY questionnaire. We will request a response regarding permission of entry 
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into the study. Permission from their health care provider will be required prior to 
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participation in any study activities.  
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Exclusion criteria for spirometry procedure only done at 1 data collection visit 
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(Visit 1) in the pre-pilot and 3 data collection visits in the pilot: chest or abdominal 
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surgery in previous 6 weeks, detached retina or eye surgery in previous month. 
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NOTE: This will be assessed at data collection visits only. If participant meets 
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these exclusion criteria, then spirometry will not be performed.  
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4.2.c. Aims 4 and 5 
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• Plans to move from Chicago during the study period 
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• Diagnosis of COPD (emphysema or chronic bronchitis) suggested by patient 
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report of doctor diagnosis or smoking history (>20 pack years) 
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• 
Inability to speak, read or understand English; 
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• Investigator discretion for safety or protocol adherence reasons 
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4.3 Excluded or Vulnerable Populations 
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EXCLUSION OF MINORS Although asthma is a disease that affects both children and 
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adults the focus of this proposal is to specifically modify and pilot test an existing 
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physical activity intervention in sedentary African American women with asthma. 
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Children are intentionally being excluded, as currently there is insufficient data available 
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in African American adults with asthma to judge the potential risk of this intervention in 
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children.  
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INCLUSION OF WOMEN AND MINORITIES The focus population for this study is 
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sedentary African-American (AA) women with asthma. All participants included in the 
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study will self-identify themselves as female and black or AA. This study population was 
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chosen as AA women are disproportionately impacted by physical inactivity and asthma 
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compared to Caucasian men and women and AA men. In particular, AA women have 
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the highest rates of asthma-related mortality and asthma-related health-care utilization. 
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Physical inactivity in asthma is particularly relevant because it is associated with worse 
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asthma outcomes, specifically, poor asthma control and respiratory function, greater 
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health care utilization, and poorer quality of life. Research aimed at addressing physical 
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inactivity and asthma control in this vulnerable population of women is needed. 
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5.0 
Subject Enrollment 
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Potential participants will be identified using 3 methods: 1) Using a validated electronic 
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health record (EHR) algorithm (Appendix 4) that identifies asthma patients with a high 
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sensitivity and specificity (99% and 96%, respectively)[1];  2) From healthcare providers 
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in internal medicine, pulmonary and allergy/asthma clinics at UI Health; 3) From women 
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that were screened in Aims 1-3 and provided permission to contact them for future 
299 
studies.  
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5.1 Asthma algorithm identification 
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The EHR asthma algorithm will be performed by Dr. William Galanter, co-investigator. 
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We have experience using this EHR algorithm at UIC for an ongoing asthma study, 
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CAPriCORN (ChairB Protocol #14111301). A HIPAA waiver will be obtained for this 
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research to allow us to gather information about potential study participants and contact 
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the potential participants. Two methods of recruitment will be used: in-person and 
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mailings. In-person recruitment will occur in the UI Health outpatient clinics. We will 
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approach potential participants who are already coming to UI Health for an appointment. 
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In a given week, we will verify ahead of time what potential participants are coming to 
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the clinics that have also been identified through the EHR asthma algorithm. A research 
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assistant(s) will come to the outpatient clinic for the potential participant's appointment, 
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obtain verbal agreement from potential participant's doctor/provider to approach the 
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potential participant, then approach the potential participant and give a brief introduction 
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about the study and ask screening questions to assess eligibility. If eligible and 
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interested, the study will be introduced to the potential participant and if interested 
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scheduled for a focus group session (Aim 1) or the first study visit (baseline interview 
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and initial data collection) which will take place in the Clinical Research Center at UIC 
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(Aim 2 and 3).  Alternatively, the recruiter and potential participant can set up another 
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day or a phone call to assess eligibility, describe the study and/or schedule the initial 
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visit. All patients approached must be identified by our EHR asthma algorithm.  
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For mail recruitment, letters along with a response card will be sent to women identified 
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by the algorithm. Within 1 week, telephone contact will be made unless the response 
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card is returned indicating that they are not interested. Participants will be called up to 5 
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times to recruit a potential subject via telephone. If the potential participant doesn’t 
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answer the phone call, a recruitment voicemail will be left up to 5 times. A brief 
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telephone screen will assess eligibility, describe the study and interest in participation. If 
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interested and eligible, patients will be scheduled for a focus group (Aim 1) or the first 
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study visit (baseline interview and initial data collection) which will take place in the 
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Clinical Research Center at UIC (Aim 2 and 3). Written informed consent will be 
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obtained in person in a private area prior to starting the focus group session (Aim 1) or 
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the baseline interview and data collection (Aim 2 and 3) for all participants. 
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5.2 Healthcare provider identification  
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In our second selection strategy, a research assistant (RA) will work closely with 
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healthcare providers who see a lot of patients with asthma in their clinics (Internal 
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Medicine, Pulmonary and Allergy/Asthma).  
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1. The RA will go to Internal Medicine, Pulmonary and/or Allergy/Asthma clinics and 
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introduce themselves to the healthcare providers and provide them a brief 
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synopsis of the research study (See study synopsis V1 11_20_17).  
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2. The RA will ask healthcare providers for potential participant's that have 
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physician diagnosed asthma and obtain verbal agreement from the healthcare 
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provider to approach the potential participant.  
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3. The RA will approach the patient and give a brief introduction about the study 
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and ask screening questions to assess eligibility using the in-person screening 
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script.  
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4. If the patient is eligible and interested, the study will be introduced to them and if 
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interested scheduled for the first study visit (baseline interview and initial data 
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collection) which will take place in the Clinical Research Center at UIC (Aim 3).   
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5. Alternatively, the potential participant may be given a flyer about the study or the 
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recruiter and potential participant can set up another time to assess eligibility, 
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describe the study and/or schedule the initial visit by phone or in-person. 
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5.3 Women screened for Aims 1-3 
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1. Women that were screened for Aims 1-3 AND provided permission to contact 
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them for future phases of this research will be contacted via preferred method of 
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contact (phone/text/email). The RA will contact the participant and give a brief 
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introduction about the study and ask screening questions to assess eligibility 
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using the telephone screening script.  
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2. If the patient is eligible and interested, the study will be introduced to them and if 
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interested the RA will obtain times that are ideal for the participant for the focus 
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group.  
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5.4 Eligibility Screening 
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If a participant does not meet eligibility criteria during screening, this will be indicated on 
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an encrypted data sheet so that participants are not approached multiple times. The de-
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identified data collected from the screen failures will be entered into REDCap by key 
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research personnel.  
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The principal investigator will separate clinical responsibilities and influence from the 
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recruitment process by having key research personnel perform eligibility screening and 
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informed consent of potential participants. The physicians will be informed of the study 
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and its’ objectives at a faculty meeting and will be asked if they have any concerns 
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regard their patients’ participation.  
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6.0 
Study Design and Procedures 
379 
 
 
380 
Aim 1 (focus groups) 
381 
We will randomly select 160 women with the goal of recruiting a random sample of 30 
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women. We will use the recruitment method described above in Section 5.0. 
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Participants will be selected to ensure representation of a range of asthma severity and 
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current age. The sample size is determined by the theoretical saturation or the point 
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when no new ideas relevant to the question are obtained, which is generally 15[2]. 
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However, a minimum of 20 is recommended for illness studies[3]. This study includes 
387 
30 participants in groups of 6-10 for focus groups. If redundancy is not noted in the 
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focus group discussion, additional participants will be included until saturation is 
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reached.   
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To ensure that the focus groups are responsive to the participants and unexpected 
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themes that might emerge, data analysis will begin after the first focus group data are 
393 
entered and continue throughout the focus group phase.  
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Study Procedures for Aim 1: 
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1. Complete eligibility screening.   
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2.  Securing informed consent. 
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3.  Complete a brief demographic form. (Appendix 5) 
399 
4.  Attend one 2 hour focus group and provide perspective on issues such as 
400 
physical activity and asthma.  Provide feedback and recommendations on 
401 
recruitment materials, content structure, and approach of ACTION intervention. 
402 
 
403 
Drs. Nyenhuis and Sharp will moderate all focus groups using an interview guide 
404 
(Appendix 6) with semi-structured open-ended questions. The interview guide will be 
405 
pre-tested for clarity, comprehension, and sensitivity and will provide sufficient flexibility 
406 
to pursue unanticipated facets of topics that emerge in focus group discussions[4].  
407 
 
408 
Each group will last approximately 2 hours and be audio-recorded and subsequently 
409 
transcribed by a member of the research team. Patients will complete written consent, 
410 
receive $50 (gift card or cash) and light snacks/refreshments.  
411 
 
412 
The focus groups will take place in a private space in one of 3 places: 
413 
1. Chicago Park District location that is in close approximation to where the 
414 
participants live. The exact location will be determined with the help of the 
415 
Chicago Park District liaison and will take into account safety of the participants 
416 
and the location of where participants live.  
417 
2. The University of Illinois at Chicago Institute of Health Research and Policy 
418 
3. For participants that are interested but unable to any other the other scheduled 
419 
visits, we will arrange for an individual interview at UI Health.  
420 
 
421 
The Chicago Park District will only host focus groups and no Chicago Park District staff 
422 
are involved in the research as recruiters or to collect data.  
423 
 
424 
Key research personnel will send a reminder text and/or call the patient (based on 
425 
patient preference) 24-48 hours prior to the focus group stating “UIC group will meet at 
426 
X time and X place.”  
427 
 
428 
Aim 2 (Pre-pilot)  
429 
We will select up to 10 women using the recruitment method described above in Section 
430 
5.0. Potential participants and participants for Aim 1 will be eligible to participate in Aim 
431 
2 if they expressed an interest to participate in future phases of the study. Participants 
432 
will be selected to ensure representation of a range of asthma severity and current age.  
433 
 
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Study Procedures for Aim 2 (Appendix 7- Table of study procedures):  
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Screening: 
436 
Potential participants will undergo eligibility screening either in-person (UI Health 
437 
patients who are already coming to UI Health for an appointment) or over the telephone.  
438 
If eligible and interested in participating in the study, they will be scheduled for their first 
439 
study visit (Visit 1). 
440 
 
441 
Visit 1: (See appendix 8 for measures) 
442 
At visit 1 the following procedures will take place at the Clinical Research Center at UIC:  
443 
1. Secure informed consent.  
444 
2. Complete a brief demographic form. 
445 
3. Spirometry performed according to American Thoracic Society guidelines. 
446 
Participants will be asked to wear nose clips and to take a deep breath in and 
447 
blow their breath out as fast as they can into the spirometer. We will perform 
448 
repeated measurements (3 to 8 times) to ensure accuracy of results. 
449 
4. Height and Weight 
450 
5. Incremental Shuttle Walk Test (ISWT) performed according to American 
451 
Thoracic Society guidelines 
452 
6. Physical activity questionaires 
453 
7. Asthma Control Questionnaire (ACQ) 
454 
8. Asthma-related quality of life questionnaire (AQLQ) 
455 
9. PROMIS measures (Global Health, social roles satisfaction, mood, sleep) 
456 
10. Asthma Knowledge and Self-efficacy questionnaire (KASE-AQ) 
457 
11. Dyspnea questionniare 
458 
12. Active Where Questionnaire 
459 
13. Self-efficacy for walking scale 
460 
14. Social support for exercise survey 
461 
15. Outcome expectation scale for exercise 
462 
16. Epworth sleepiness scale-pending permission 
463 
17. Sleep Apnea Scale of the Sleep Disorders Questionnaire- pending permission 
464 
18. Pittsburgh Sleep Quality Instrument 
465 
19. Schedule Visit 2 with participant 
466 
 
467 
Key research personnel will obtain consent in a private room in the Clinical 
468 
Research Center. After consent is obtained, the other study procedures will be 
469 
completed. This visit will last approximately 2 hours and upon completion the 
470 
participant will receive $25 cash or gift card.  Patients will be offered light 
471 
snacks/refreshments at this visit.  
472 
 
473 
Participants will then be provided the following equipment at Visit 1: 
474 

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Actigraph accelerometer: This will be given to participants to assess their baseline 
475 
and post-intervention daily number of steps. Participants will be verbally instructed 
476 
to wear it attached to their waist at all times while awake. The Actigraph 
477 
accelerometer (Figure 3) is a research accelerometer (1.8 inches at its largest 
478 
dimension, weight 19 grams). This will be returned at Visit 2. The data from the 
479 
accelerometers will be downloaded to Actigraph software (ActiLife 6.13.3) when the 
480 
accelerometers are returned. Only study ID will be used in the actigraph software. 
481 
No identifiable information will be maintained in the Actigraph software. 
482 
 
483 
Figure 3. Actigraph accelerometer  
484 
 
485 
Visits 2-4 (1-2 weeks after each prior visit): 
486 
Visits 2-4 will take place at UI Health/UIC or a Chicago Park District (CPD) location that 
487 
is in close approximation to where the participants live. The exact CPD location will be 
488 
determined with the help of the Chicago Park District liaison and will take into account 
489 
safety of the participants and the location of where participants live. The Chicago Park 
490 
District will only provide space for these visits and no Chicago Park District staff are 
491 
involved in the research as recruiters or to collect data. 
492 
 
493 
At visits 2-4 the following procedures will occur: 
494 
1. Collection of accelerometers (Visit 2 only) and Fitbit (Visit 4 only).  
495 
2. Attend a 2 hour group session at the Chicago Park District or at UI 
496 
Health/UIC. At the group session, participants will receive basic asthma 
497 
education, physical activity education and watch a video on how to get started 
498 
to walk. Participants will be asked to share their experiences with asthma and 
499 
physical activity.  
500 
3. Each participant will be given an individualized step-goal not to exceed 3000 
501 
steps above their baseline calculated from accelerometer data. (Visit 2 and 3 
502 
only) 
503 
4. Each participant will be given an ACTION participant manual (Visit 2 only). 
504 
5. Participants will be asked to complete a session evalution form. (Appendix 9) 
505 
6. Summative evaluation (visit 4 only; Appendix 10) 
506 
 
507 
 
508 

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Key research personnel will send a reminder text, call and/or email (based on patient 
509 
preference) up to 3 times the prior week to the group session stating “ACTION group 
510 
will meet at X time and X place.”  
511 
 
512 
Reminder messages will also be sent via phone, text or email (based on participant 
513 
preference) up to 3 times per week to help them attain their weekly step goal (See 
514 
Appendix 11 for sample text messaging).  
515 
 
516 
An interventionist and/or Dr. Nyenhuis will attend the group sessions. Each group will 
517 
last approximately 2 hours and be audio-recorded to assess for intervention fidelity. If a 
518 
participant declines audio-recording the session, then the session will not be recorded. 
519 
The PI or co-investigator may then observe a group session intermittently to assess for 
520 
intervention fidelity.  If the session is recorded, the PI will review portions of the session. 
521 
The sessions will be deleted once the pre-pilot is complete. These audio recordings will 
522 
not be transcribed. Patients will receive light snacks/refreshments at each session.  
523 
 
524 
Key research personnel will send a reminder text, email and/or call the patient (based 
525 
on patient preference) 24-48 hours prior to each visit. 
526 
 
527 
Participants will then be provided the following equipment at Visit 2 and will be asked to 
528 
return on Visit 4: 
529 
1) Fitbit® physical activity monitor: Participants will be verbally instructed to wear it on 
530 
their wrist at all times while awake. The Fitbit (Figure 3.a) is a commercially-available 
531 
physical activity monitor (0.83 inches wide, weight 0.8 ounces). The wristbands are 
532 
adjustable and data from our focus groups revealed that participants would prefer a 
533 
wrist-based than a waist-based physical activity monitor.  Participants will be asked to 
534 
download the fitbit app to their smartphone or tablet and asked to create an account. 
535 
Participants will be referred to the Fitbit website for troubleshooting. This will allow for 
536 
physical activity data transmission to the Fitbit study database which will not contain any 
537 
identifiable information. A previous survey found that over 90% of our patients had a 
538 
smartphone or tablet. If a participant is unable to or does not want to download the fitbit 
539 
app then they will write their daily steps into a journal which they will bring to each study 
540 
visit. Participants will not be responsible for the cost of the Fitbit if it is lost or stolen. 
541 
 
542 
Figure 4. Fitbit physical activity monitor 
543 
 
544 

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Daily physical activity, heart rate and status of the Fitbit (e.g., battery) will be monitored 
545 
in real time using a Fitbit study database. Only physical activity data (i.e., step counts, 
546 
time worn using heart rate, minutes active, distance walked) of the participant will be 
547 
kept in the Fitbit study database. This is necessary for recording of detailed physical 
548 
activity data as the pedometers have limited data storage capacity. Only study ID will be 
549 
used in the Fitbit study database. No identifiable information will be maintained in the 
550 
Fitbit database.  
551 
 
552 
Participants will be given a $25 gift card or cash after completion of study visit 4.  
553 
 
554 
Aim 3 (Pilot)  
555 
We will randomly select 800 women with the goal of recruiting a random sample of 80 
556 
women. We will use the recruitment method described above in Section 5.0. 
557 
Participants will be selected to ensure representation of a range of asthma severity, BMI 
558 
and current age. Potential participants for Aim 1 and 2 will be eligible to participate in 
559 
Aim 3 if they did not participate in the focus groups or the pre-pilot but expressed an 
560 
interest to participate in future phases of the study.  
561 
 
562 
Study Procedures for Aim 3 (Appendix 7- Table of study procedures):  
563 
Screening: 
564 
Potential participants will undergo eligibility screening either in-person (UI Health 
565 
patients who are already coming to UI Health for an appointment) or over the telephone.  
566 
If eligible and interested in participating in the study, they will be scheduled for their first 
567 
study visit (Visit 1). 
568 
 
569 
3 Data Collection Visits: Baseline (week 0/Visit 1), post adoption phase (week 
570 
24/Visit 7a/b) and post maintenance phase (week 36/Visit 9) in all participants 
571 
(See appendix 8 for measures) 
572 
At the data collection visits, the following procedures will take place at the Clinical 
573 
Research Center at UIC or Chicago Park District location:  
574 
1. Secure informed consent (1st visit only).  
575 
2. Complete a brief demographic form. 
576 
3. Spirometry performed according to American Thoracic Society guidelines. 
577 
Participants will be asked to wear nose clips and to take a deep breath in and 
578 
blow their breath out as fast as they can into the spirometer. We will perform 
579 
repeated measurements (3 to 8 times) to ensure accuracy of results. 
580 
4. Height and Weight 
581 
5. Incremental Shuttle Walk Test (ISWT) performed according to American 
582 
Thoracic Society guidelines 
583 
6. Physical activity questionaires 
584 

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7. Asthma Safety Measures 
585 
8. Asthma Control Questionnaire (ACQ) 
586 
9. Asthma-related quality of life questionnaire (AQLQ) 
587 
10. Adult Asthma Adherence Questionnaire (AAAQ) 
588 
11. PROMIS measures (Global Health, social roles satisfaction, mood, sleep) 
589 
12. Active Where Questionnaire 
590 
13. Self-efficacy for walking scale 
591 
14. Social support for exercise survey 
592 
15. Outcome expectation scale for exercise 
593 
16. Sleep Apnea Scale of the Sleep Disorders Questionnaire 
594 
17. Pittsburgh Sleep Quality Instrument 
595 
18. Neighborhood safety and social cohesion questionnaire 
596 
19. Study randomization (1st visit only) 
597 
20. Schedule asthma and physical activity (PA) education session with participant 
598 
(1st visit only) 
599 
 
600 
Key research personnel will obtain consent in a private room in the Clinical 
601 
Research Center. After consent is obtained, the other study procedures will be 
602 
completed.  
603 
 
604 
This visit will last approximately 2 hours and upon completion the participant will 
605 
receive $35 cash or gift card.  Patients will be offered light snacks/refreshments 
606 
at this visit and given a visit summary sheet with their blood pressure, heart rate, 
607 
weight, height, oxygen level, date of next study visit and a copy of spirometry 
608 
results if desired.  
609 
 
610 
Participants will then be provided the following equipment at these data collection 
611 
visits: 
612 
Actigraph accelerometer: This will be given to participants to assess their baseline 
613 
and post-intervention daily number of steps. Participants will be verbally instructed 
614 
to wear it attached to their wrist at all times while awake. The Actigraph 
615 
accelerometer (Figure 3) is a research accelerometer (1.8 inches at its largest 
616 
dimension, weight 19 grams). This will be returned within 2 weeks of the data 
617 
collection visit. The accelerometers can be returned either in person at the asthma 
618 
and PA session, in a postage paid envelope or the participant and the research 
619 
assistant will find a mutually agreeable place to pick up the accelerometer from the 
620 
participant. The participant will not incur any charges if the accelerometer is lost or 
621 
stolen. The data from the accelerometers will be downloaded to Actigraph software 
622 
(ActiLife 6.13.3) when the accelerometers are returned. Only study ID will be used 
623 

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in the actigraph software. No identifiable information will be maintained in the 
624 
Actigraph software.  
625 
 
626 
Participants are typically asked to wear the accelerometer for 7 days (does not 
627 
have to be consecutive).  However, valid baseline measurement of activity can be 
628 
obtained with an average of 10 hours per day for 4 days.  This is the minimum 
629 
amount of accelerometer data required to continue participation in the intervention.  
630 
If the participant does not wear the accelerometer for sufficient time to provide valid 
631 
baseline measure (ie. an average of 10 hours per day for 4 days), they will be 
632 
offered a second opportunity to wear the accelerometer. If the participant declines 
633 
or is unable to wear the accelerometer again within 3 weeks of returning the 
634 
accelerometer, then the participant will be withdrawn from the study. 
635 
 
636 
Enhanced Usual Care Group (home-based walking program): The comparison 
637 
group will be instructed to achieve a static goal of 10,000 steps per day. The US 
638 
Surgeon General recommends accumulating 30 minutes of activity most days of the 
639 
week. Assuming that an individual gets 6,000 steps from their other daily activities, 30 
640 
minutes of walking can help one achieve a goal of approximately 10,000 steps per day.  
641 
 
642 
Participants will be given a Fitbit Charge HR® which will measure their daily steps (see 
643 
more detail below under visit 2). In order to attention-match for interactions with study 
644 
staff, participants will attend an asthma education and physical activity training session. 
645 
Newsletters with walking tips for AA women and asthma education topics will be sent 
646 
twice during the intervention phases to participants in this group. Participants will come 
647 
to the Clinical Research Center for data collection at weeks 24 (Visit 7b) and 36 (Visit 9) 
648 
described in more detail below.  
649 
 
650 
Asthma and physical activity (PA) education session for all participants (1-6 
651 
weeks after baseline data collection visit) 
652 
The asthma and PA education session will take place at UI Health/UIC or a Chicago 
653 
Park District (CPD) location that is in close approximation to where the participants live. 
654 
The exact CPD location will be determined with the help of the Chicago Park District 
655 
liaison and will take into account safety of the participants and the location of where 
656 
participants live. The Chicago Park District will only provide space for these visits and 
657 
no Chicago Park District staff are involved in the research as recruiters or to collect 
658 
data. Two separate asthma/PA education sessions will take place, one for enhanced 
659 
usual care group and one for those randomized into the intervention group.  
660 
 
661 
At the asthma/PA education session the following procedures will occur: 
662 
1. Collection of accelerometers for those that have not already returned it. 
663 

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2. Attend a 2 hour group session at the Chicago Park District or at UI 
664 
Health/UIC. At the group session, participants will receive didactic asthma 
665 
education and information on how to engage in physical activity with their 
666 
asthma.   
667 
3. Participants will be asked to complete a session evalution form. (Appendix 9) 
668 
4. Participants will be given $5 cash to assist with travel expenses incurred for 
669 
the visit.  
670 
 
671 
Key research personnel will send a reminder text, call and/or email (based on patient 
672 
preference) up to 3 times the prior week to the group session stating “Asthma and 
673 
physical activity session will meet at X time and X place.”  
674 
 
675 
An asthma educator, a research assistant(s) and/or Dr. Nyenhuis will attend the 
676 
education session. Each education session will last approximately 2 hours. Patients will 
677 
receive light snacks/refreshments at each session.  
678 
 
679 
For missed sessions, make-up sessions will be offered (in-person or by video). 
680 
Continuation in the program will be decided by the PI on a case by case basis. 
681 
Participants will be strongly encouraged to make up missed sessions prior to the next 
682 
scheduled group session (intervention group) or data collection visit (enhanced usual 
683 
care group). 
684 
 
685 
Participants will be given the following equipment at the asthma/PA education session: 
686 
1) Fitbit® physical activity monitor: Participants will be verbally instructed to wear it on 
687 
their wrist at all times while awake. The Fitbit (Figure 4) is a commercially-available 
688 
physical activity monitor (0.83 inches wide, weight 0.8 ounces). The wristbands are 
689 
adjustable and data from our focus groups revealed that participants would prefer a 
690 
wrist-based than a waist-based physical activity monitor.  Participants will be asked to 
691 
download the fitbit app to their smartphone or tablet and asked to create an account. 
692 
Participants will be referred to the Fitbit website for troubleshooting. This will allow for 
693 
physical activity data transmission to the Fitbit study database which will not contain any 
694 
identifiable information. If a participant is unable to or does not want to download the 
695 
fitbit app then they will write their daily steps into a journal which they will bring to each 
696 
study visit. Participants will not be responsible for the cost of the Fitbit if it is lost or 
697 
stolen. 
698 
 
699 
Daily physical activity, heart rate and status of the Fitbit (e.g., battery) will be monitored 
700 
in real time using a Fitbit study database. Only physical activity data (i.e., step counts, 
701 
time worn using heart rate, minutes active, distance walked) of the participant will be 
702 
kept in the Fitbit study database. This is necessary for recording of detailed physical 
703 

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activity data as the pedometers have limited data storage capacity. Only study ID will be 
704 
used in the Fitbit study database. No identifiable information will be maintained in the 
705 
Fitbit database.  
706 
 
707 
Group sessions (Intervention group only): Women randomized into the intervention 
708 
group will also attend group sessions in 2 phases: Adoption and Maintenance (See 
709 
Figure 2). 
710 
 
711 
Adoption phase (5 sessions every 4 weeks) 
712 
The group session will take place at UI Health/UIC or a Chicago Park District (CPD) 
713 
location that is in close approximation to where the participants live. The exact CPD 
714 
location will be determined with the help of the Chicago Park District liaison and will take 
715 
into account safety of the participants and the location of where participants live. The 
716 
Chicago Park District will only provide space for these visits and no Chicago Park 
717 
District staff are involved in the research as recruiters, interventionists, asthma 
718 
educators or to collect data.  
719 
 
720 
At each group session the following will occur: 
721 
1. Women will attend a 2 hour group session at the Chicago Park District or at 
722 
UI Health/UIC. At the group session, participants will continue to receive 
723 
asthma education (short videos and/or didactic session), watch a video on 
724 
how to get started to walk and what barriers they may face. Participants will 
725 
be asked to share their experiences engaging in physical activity with asthma.  
726 
2. Participant will be given an individualized step-goal not to exceed 3000 steps 
727 
above their baseline calculated from accelerometer data over the entire 
728 
course of the study.  
729 
3. Each participant will be given an ACTION participant manual (1st group 
730 
session only). 
731 
4. Participants will be encouraged to walk during the group session for up to 15 
732 
minutes. The interventionist and Chicago Park District liaison will identify safe 
733 
locations for the women to walk at the group session site. Women will be able 
734 
to walk at their own pace and stop at anytime. If the participant does not want 
735 
to participate in the walking portion of the group visit they may opt-out by 
736 
verbally telling the interventionist that they do not want to participate.  
737 
5. Participants will be asked to complete a session evaluation form. (Appendix 
738 
9). 
739 
6. Participants will be given $5 cash to assist with travel expenses incurred for 
740 
each group visit.  
741 
 
742 

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At the last group session in the adoptive phase, the following procedures will occur and 
743 
the participant will receive $35 cash or gift card for this visit only: 
744 
: 
745 
1. Spirometry performed according to American Thoracic Society guidelines. 
746 
Participants will be asked to wear nose clips and to take a deep breath in and 
747 
blow their breath out as fast as they can into the spirometer. We will perform 
748 
repeated measurements (3 to 8 times) to ensure accuracy of results. 
749 
2. Weight 
750 
3. Incremental Shuttle Walk Test (ISWT) performed according to American 
751 
Thoracic Society guidelines 
752 
4. Accelerometer distribution 
753 
5. Summative evaluation (visit 7 only; Appendix 10) 
754 
 
755 
If a participant is not able to attend this session, we will contact the patient to scheduled 
756 
an in person data collection visit at UI Health/UIC where the above procedures (#1-3) 
757 
will be completed.  
758 
 
759 
During or after Visit 7a is complete, participants will complete REDCap paper surveys ( 
760 
in person) or will be sent a link (email or text) to complete the following REDCap 
761 
surveys electronically: 
762 
1. Physical activity questionaires 
763 
2. Asthma Safety Measures 
764 
3. Asthma Control Questionnaire (ACQ) 
765 
4. Asthma-related quality of life questionnaire (AQLQ) 
766 
5. Adult Asthma Adherence Questionnaire (AAAQ) 
767 
6. PROMIS measures (Global Health, social roles satisfaction, mood, sleep) 
768 
7. Active Where Questionnaire 
769 
8. Self-efficacy for walking scale 
770 
9. Social support for exercise survey 
771 
10. Outcome expectation scale for exercise 
772 
11. Sleep Apnea Scale of the Sleep Disorders Questionnaire 
773 
12. Pittsburgh Sleep Quality Instrument 
774 
Key research personnel will send a reminder text, call and/or email (based on patient 
775 
preference) up to 3 times the prior week to the group session stating “ACTION Asthma 
776 
group will meet at X time and X place.”  
777 
 
778 
Reminder messages will also be sent via phone, text or email (based on participant 
779 
preference) up to 3 times per week to help them attain their weekly step goal (See 
780 
Appendix 11 for sample text messaging).  
781 
 
782 

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An interventionist and/or Dr. Nyenhuis will attend the group sessions. Each group will 
783 
last approximately 2 hours and may be audio-recorded to assess for intervention fidelity. 
784 
If a participant declines audio-recording the session, then the session will not be 
785 
recorded. The PI or co-investigator may then observe a group session intermittently to 
786 
assess for intervention fidelity.  If the session is recorded, the PI will review portions of 
787 
the session. The sessions will be deleted once the pilot is complete. These audio 
788 
recordings will not be transcribed. Patients will receive light snacks/refreshments at 
789 
each session.  
790 
 
791 
If any of the group visits 3-7 are missed, the woman is asked to arrive 15 minutes early 
792 
for the next meeting to receive an update. Her report will be emailed/phones/texted to her 
793 
depending on her preference.  
794 
 
795 
If a woman has missed several group visits and we have been unable to contact her, we 
796 
will mail her a letter indicating to call us.   
797 
 
798 
Visit 7b: 24 week data collection (Enhanced Usual Care only) 
799 
At Visit 7b the following procedures will take place at the Clinical Research Center at 
800 
UIC: 
801 
1. Spirometry performed according to American Thoracic Society guidelines. 
802 
Participants will be asked to wear nose clips and to take a deep breath in and 
803 
blow their breath out as fast as they can into the spirometer. We will perform 
804 
repeated measurements (3 to 8 times) to ensure accuracy of results. 
805 
2. Weight 
806 
3. Incremental Shuttle Walk Test (ISWT) performed according to American 
807 
Thoracic Society guidelines 
808 
4. Accelerometer distribution 
809 
5. Physical activity questionaires 
810 
6. Asthma Safety Measures 
811 
7. Asthma Control Questionnaire (ACQ) 
812 
8. Asthma-related quality of life questionnaire (AQLQ) 
813 
9. Adult Asthma Adherence Questionnaire (AAAQ) 
814 
10. PROMIS measures (Global Health, social roles satisfaction, mood, sleep) 
815 
11. Active Where Questionnaire 
816 
12. Self-efficacy for walking scale 
817 
13. Social support for exercise survey 
818 
14. Outcome expectation scale for exercise 
819 
15. Sleep Apnea Scale of the Sleep Disorders Questionnaire 
820 
16. Pittsburgh Sleep Quality Instrument 
821 
 
822 

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This visit will last approximately 2 hours and upon completion the participant will receive 
823 
$35 cash or gift card.  
824 
 
825 
Participants will be given a postage paid envelope and be asked to mail the 
826 
accelerometer back to study team after wearing it for 1 week. Reminder 
827 
calls/texts/emails will be sent if we have not received the accelerometer within 2 weeks 
828 
of completion of visit 7. If needed, a central location for drop-off of the accelerometer 
829 
may be arranged with the participant.  
830 
 
831 
Maintenance Phase: During the maintenance phase, participants will continue to 
832 
receive reminder text messages to help them attain their weekly step goal no more than 
833 
once a week.  
834 
  
835 
Visit 8: Post-maintenance booster session and data collection (12 weeks after 
836 
Visit 7) Booster session will only be for intervention group. 
837 
 
838 
At visit 8 booster session the following procedures will occur: 
839 
1. Attend a 2 hour group session at the Chicago Park District or at UI 
840 
Health/UIC. At the group session, participants will review successes attained 
841 
and barriers, lapses, and relapses encountered.  
842 
2. Participants will be asked to complete a session evalution form. (Appendix 9). 
843 
3. Participants will be given $5 cash to assist with travel expenses incurred for 
844 
the group visit.  
845 
 
846 
An interventionist and/or Dr. Nyenhuis will attend the group session. The group will last 
847 
approximately 2 hours and may be digitally recorded to assess for intervention fidelity. If 
848 
a participant declines audio-recording the session, then the session will not be 
849 
recorded. The PI or co-investigator may then observe a group session intermittently to 
850 
assess for intervention fidelity.  If the session is recorded, the PI will review portions of 
851 
the session. The session will be deleted once the pilot is complete. These audio 
852 
recordings will not be transcribed. Patients will receive light snacks/refreshments at the 
853 
session.  
854 
 
855 
Post-maintenance data collection (all participants) 
856 
The following procedures will take place at the Chicago Park District (intervention 
857 
group) or Clinical Research Center at UIC (enhanced usual care):  
858 
1. Spirometry performed according to American Thoracic Society guidelines. 
859 
Participants will be asked to wear nose clips and to take a deep breath in and 
860 
blow their breath out as fast as they can into the spirometer. We will perform 
861 
repeated measurements (3 to 8 times) to ensure accuracy of results. 
862 

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2. Weight 
863 
3. Incremental Shuttle Walk Test (ISWT) performed according to American 
864 
Thoracic Society guidelines 
865 
4. Distribution of accelerometer 
866 
 
867 
 
868 
The following questionnaires will be completed by REDCap survey: 
869 
1. Physical activity questionaires 
870 
2. Asthma Safety Measures 
871 
3. Asthma Control Questionnaire (ACQ) 
872 
4. Asthma-related quality of life questionnaire (AQLQ) 
873 
5. Adult Asthma Adherence Questionnaire (AAAQ) 
874 
6. PROMIS measures (Global Health, social roles satisfaction, mood, sleep) 
875 
7. Active Where Questionnaire 
876 
8. Self-efficacy for walking scale 
877 
9. Social support for exercise survey 
878 
10. Outcome expectation scale for exercise 
879 
11. Sleep Apnea Scale of the Sleep Disorders Questionnaire 
880 
12. Pittsburgh Sleep Quality Instrument 
881 
 
882 
This visit will last approximately 2 hours and upon completion the participant will 
883 
receive $35 cash or gift card.  Patients will be offered light snacks/refreshments 
884 
at this visit.  
885 
 
886 
Participants will be given a postage paid envelope and be asked to mail the 
887 
accelerometer back to study team after wearing it for 1 week. Reminder 
888 
calls/texts/emails will be sent if we have not received the accelerometer within 2 weeks 
889 
of completion of visit 8. If needed, a central location for drop-off of the accelerometer 
890 
may be arranged with the participant.  
891 
 
892 
Aims 4 & 5 (Adapting Intervention Tools) 
893 
We will recruit up to 15 AA women with asthma from our database of ~80 AA women 
894 
with asthma that have given us permission to contact them for research studies. These 
895 
women have already been identified as having asthma either through physician 
896 
diagnosis and/or the use of a validated electronic health record (EHR) algorithm that 
897 
identifies asthma patients with a high sensitivity and specificity (99% and 96%, 
898 
respectively)[15, 16]. Potential participants will be contacted and asked screening 
899 
questions to ensure they are still in our target age range of 18-70 years. Participants will 
900 
be selected to ensure representation of age ranges. The sample size is determined by 
901 
the theoretical saturation or the point when no new ideas relevant to the question are 
902 

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[3-9-2020] 
obtained, which is generally 15[17].  
903 
 
904 
Study Procedures for Aims 4 and 5: 
905 
1. Complete eligibility screening.   
906 
2.  Securing informed consent. 
907 
3.  Complete a brief demographic form. (Appendix 5) 
908 
4.  Attend three 90 minute focus groups and provide perspective on issues such 
909 
as video content, video scene selection and final video product.  
910 
 
911 
Drs. Nyenhuis and a nurse interventionist will moderate all focus groups using an 
912 
interview guide (Appendix 12) with semi-structured open-ended questions. The 
913 
interview guide will be pre-tested for clarity, comprehension, and sensitivity and will 
914 
provide sufficient flexibility to pursue unanticipated facets of topics that emerge in focus 
915 
group discussions[4].  
916 
 
917 
Each group will last approximately 90 minutes and be audio-recorded and subsequently 
918 
transcribed. If one of the focus group members decline to be audio-recorded the 
919 
session will not be audio-recorded and only field notes will be collected. Patients will 
920 
complete written consent (1st session only), receive $50 (cash) and light 
921 
snacks/refreshments at each focus group.  
922 
 
923 
The focus groups will take place in a private space at the University of Illinois at 
924 
Chicago.  
925 
 
926 
Key research personnel will send a reminder text and/or call the patient (based on 
927 
patient preference) 24-48 hours prior to the focus group stating “ACTION asthma group 
928 
will meet at X time and X place.”  
929 
 
930 
Aim 6 (Dissemination of study findings to study participants) 
931 
We will disseminate our study findings and next steps to study participants by way of a 
932 
newsletter. Using feedback from the CCTS Community Advisory Board we developed 
933 
three newsletters to be disseminated to our study participants. The newsletters focus on 
934 
thanking our participants, study findings, next steps and educational content related to 
935 
physical activity and/or asthma. The newsletter will be sent on a monthly basis for 3 
936 
months and will be disseminated by email, text or mail based on the preferred 
937 
communication each participant indicated in the study. A pdf of the newsletters will be 
938 
also available on Dr. Nyenhuis’ Department of Medicine Research Page.  
939 
 
940 
7.0 
Expected Risks/Benefits 
941 
 
942 
The research involves minimal risk:  
943 

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944 
1. There is a chance that answering questions about their health may cause 
945 
participants to become upset or distressed.  If this should happen during a focus 
946 
group or group session, the participant may take a break from the group or leave 
947 
the group entirely.   
948 
2. Questionnaires: given that some questions ask personal information; it is 
949 
possible that participants will be uncomfortable answering them. Participants will 
950 
be explained they do not have to answer any question they are uncomfortable 
951 
with. 
952 
3. There is also a chance for loss of privacy and loss of confidentiality in the unlikely 
953 
event that unauthorized persons should see study data.  Many protections will be 
954 
taken to decrease the chances that this happens.  
955 
4. Spirometry (lung function test): risks associated with spirometry are minimal for 
956 
most people. Because the test involves rapid and forced breathing, some people 
957 
may experience temporary (lasting up to a few minutes) shortness of breath, 
958 
lightheadedness and minor chest soreness. In rare cases, the participant may 
959 
hyperventilate and become dizzy during spirometric testing. Any participant who 
960 
feels faint should be guided onto the chair with her head down towards the 
961 
knees, and encouraged to breathe slowly and deeply until she recovers. If the 
962 
participant fails to recover normal breathing, faints, or reports feeling ill, the 
963 
research assistant will summon the CRC nurse manager and physician 
964 
immediately. The physician should always be consulted if there is any question 
965 
regarding the participant’s safety status during the exam.  
966 
5. Risk of pulmonary event: subjects will be asked to increase their daily physical 
967 
activity and will perform up to 15 minutes of walking during the intervention group 
968 
sessions, so there is the possibility of a pulmonary complication, such as an 
969 
increase in respiratory symptoms (shortness of breath, cough, wheezing). We will 
970 
minimize this risk by careful participant selection. Previous studies have shown 
971 
the safety of increasing physical activity in sub-optimally controlled persistent 
972 
asthma (Ma J et al.  Ann Am Thorac Soc. 2015; 12(1): 1–11.) 
973 
 
974 
Participants may have direct personal benefits from participating in the pre-pilot and 
975 
pilot, as they will receive asthma education and learn how to best exercise with asthma. 
976 
Further, participants may enjoy talking with other people about their experiences with 
977 
asthma and physical activity. The participant’s involvement will offer important 
978 
information that will help refine and test the feasibility and acceptability of a physical 
979 
activity program to improve the life of women with asthma.  
980 
 
981 
8.0 
Data Collection and Management Procedures 
982 
Data collected during screening of participants will be entered into REDCap by key 
983 
research personnel. For subjects that are interested in participating in future studies or 
984 
future phases of the study, their contact information will be entered and secured in a 
985 

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REDCap database. The asthma algorithm output (raw data) will only be seen by Dr. 
986 
Galanter. The data from the algorithm that is needed to contact the potential participants 
987 
(name, address, phone number, date of birth and medical record number) will be kept 
988 
within the hospital intranet, behind the clinical hospital firewall that is password 
989 
protected and will be accessed only by the PI and selected key research personnel. 
990 
 
991 
The data from the focus groups (Aims 1, 4 and 5) will be in the form of audio recordings 
992 
with no use of names. Drs. Nyenhuis and Sharp will review focus group transcriptions to 
993 
identify recurring themes especially those focused on barriers and enablers to 
994 
PA/walking and video adaptation and video acceptability. We will explore the distribution 
995 
across the groups by key variables such as asthma severity and age.  In this manner, 
996 
analysis will consider the context of the responses including characteristics of the 
997 
participants[5]. Information drawn from focus groups will not be shared with group 
998 
participants. The audio of the focus groups will be destroyed after transcription. The 
999 
transcript data will be destroyed immediately before the research has been closed via a 
1000 
Final Report.  
1001 
 
1002 
The data from the pre-pilot and pilot will be in the form of a demographics form, surveys, 
1003 
Fitbit data (step counts, time worn using heart rate, minutes active, distance walked), 
1004 
accelerometer data and spirometry results. Each form, survey or report will have the 
1005 
participant’s study ID only. The participant’s height and weight will be directly entered 
1006 
into REDCap by key research personnel. After each study visit, key research personnel 
1007 
will ensure that the data is entered into the REDCap database. Paper copies of the 
1008 
demographics form, paper surveys (if used), and spirometry results will be kept in a 
1009 
locked cabinet or drawer separate from the study ID code. The paper copies will be 
1010 
destroyed immediately before the research has been closed via a Final Report. 
1011 
Electronic REDCap surveys will also be used and once complete will be automatically 
1012 
transferred into REDCap. 
1013 
 
1014 
Other clinical data (ie. laboratory data, pulmonary function tests, sleep tests) will be 
1015 
obtained from the participant’s UI Health electronic medical record (EMR). This data will 
1016 
be entered into REDCap and will have the participant’s study ID only. This data will be 
1017 
used to assess the feasibility and preliminary efficacy of the PA intervention in different 
1018 
phenotypes of asthma.  
1019 
Actual data and information connecting a study participant’s name and study identifying 
1020 
number is kept in a locked file drawer in the PI’s office.  The coding system will be kept 
1021 
in a locked cabinet or drawer separate from the actual data.  Research investigators 
1022 
performing the statistical analyses data will not have access to information that can 
1023 
connect up the actual identity of a study participant and their data.  All workstations 
1024 
require the use of a password in order to gain access.  When leaving a workstation 
1025 
unattended, the user must log-out or lock their computer.  Users are required to use 
1026 

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screen savers that will be activated after ten minutes of inactivity and are password 
1027 
protected.  
1028 
 
1029 
9.0 
Data Analysis/Quality Control 
1030 
 
1031 
Aim 1: Focus Group Data Analysis/Quality Control 
1032 
To ensure that the focus groups are responsive to the participants and unexpected 
1033 
themes that might emerge, data analysis will begin after the first focus group data are 
1034 
entered and continue throughout the focus group phase. Drs. Nyenhuis and Sharp will 
1035 
review focus group transcriptions to identify recurring themes especially those focused 
1036 
on barriers and enablers to PA/walking and explore the distribution across the groups 
1037 
by key variables such as asthma severity and age.  In this manner, analysis will 
1038 
consider the context of the responses including characteristics of the participants[5]. 
1039 
The list of themes will serve as the data for the intervention refinement, which will occur 
1040 
as part of Aim 1b.  
1041 
 
1042 
The intent of Aim 1b is to integrate the barriers and facilitators to PA unique to 
1043 
sedentary AA women with asthma obtained from Aim 1a to adapt a validated walking 
1044 
intervention. A multi-disciplinary asthma advisory team, consisting of kinesiologist- Dr. 
1045 
Marquez, exercise-induced asthma specialist- Dr. Moy, PA in women specialist- Dr. 
1046 
Wilbur and behavioral scientist- Dr. Sharp will meet to review the results and generate 
1047 
independent suggestions related to safe and effective PA with asthma and asthma-
1048 
related barriers and enablers to PA. This team will also address modifications specific to 
1049 
asthma such as: 1) identification of asthma triggers (exercise, pollens, cold-air); 2) 
1050 
adequate warm-up prior to physical activity; 3) medication pre-treatment prior to 
1051 
physical activity; 4) adequate cool-down after physical activity; 5) use of breathing 
1052 
exercises. The group will review and rank order all suggestions for intervention 
1053 
modifications. Final decisions will be determined by the Asthma Advisory Team: Drs. 
1054 
Marquez, Sharp, Moy, Wilbur and Nyenhuis. The resulting intervention will be used in 
1055 
Aim 2 (Pre-pilot). 
1056 
 
1057 
Aim 2: Pre-pilot ACTION Intervention: The qualitative data collected during pre-pilot will 
1058 
include but not be limited to, measures of time to administer and recruitment, 
1059 
exploration of variance on measures (ceiling and floor effects), formative evaluations 
1060 
from group sessions and issues with data collection and entry. The asthma advisory 
1061 
team will review all aspects of the pre-pilot and recommend refinement of the content, 
1062 
logistics, or process of the intervention. No further modifications will be made and we 
1063 
will proceed to obtaining IRB approval for the final aim of the study (Aim 3).  
1064 
 
1065 
Aim 3: Pilot ACTION Intervention: The qualitative data collected during pilot will include 
1066 
but not be limited to, measures of time to administer and recruitment, exploration of 
1067 
variance on measures (ceiling and floor effects), formative evaluations from group 
1068 
sessions and issues with data collection and entry. The quantitative data collected will 
1069 
include lung function, height/weight, body mass index, shuttle walk test time, 
1070 
surveys/questionnaires, EMR data (laboratory data, pulmonary function tests and sleep 
1071 

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tests). This data will be stored in REDCap and will be monitored periodically by the 
1072 
study statistician.  
1073 
 
 
1074 
Aim 4: Adapting Intervention tools: Audio recordings of the focus groups will be 
1075 
transcribed and compared to field notes collected during the focus group meetings. An 
1076 
initial list of codes will be used based upon the facilitator guides used in the focus 
1077 
groups. The meeting transcript will be coded independently by the PI and a research 
1078 
assistant and will meet several times to group the codes into categories and add 
1079 
definitions for each code so that the coding process is consistent. The list of themes will 
1080 
serve as the data for the video refinement. Data analysis strategies for demographic 
1081 
data will use descriptive statistics.  
1082 
 
1083 
A multi-disciplinary research team, consisting of an asthma specialist- Dr. Nyenhuis, PA 
1084 
in women specialist- Dr. Wilbur (mentor on Dr. Nyenhuis’ K award) and behavioral 
1085 
scientist- Dr. Sharp (primary mentor on Dr. Nyenhuis’ K award) will meet to review the 
1086 
results from the initial focus group meeting. The group will review and rank order all 
1087 
suggestions for video modifications. Final decisions will be determined by Drs. 
1088 
Nyenhuis, Wilbur and Sharp. The resulting suggestions of asthma content, setting and 
1089 
language will be used to develop the script for the videos working with an experienced 
1090 
videographer and filming will begin.  
1091 
 
1092 
The relevant raw video footage will be presented at the second focus group meeting. 
1093 
The women will be asked to provide feedback (written and oral) on the selection of 
1094 
video scenes from the raw video footage clips that are relevant to the added asthma 
1095 
video content. The written feedback includes a scoring sheet for each video. Each video 
1096 
will be scored two times. Once for relevance of the asthma content to engaging in 
1097 
physical activity and second for the usefulness in stimulating group discussion. Each 
1098 
score will be on a 5-point scale from not relevant to very relevant or not useful to very 
1099 
useful. Field notes will be taken during the meeting and the session will be audio 
1100 
recorded and subsequently transcribed. The field notes and meeting transcript will be 
1101 
reviewed by the PI and research assistant independently. The mean ratings of video 
1102 
scenes’ relevance and usefulness will be calculated. The mean scores for each video 
1103 
will be used as rationale for replacing unacceptable scores (<3) The suggestions for 
1104 
scene inclusion will be reviewed and finalized with the multi-disciplinary research team 
1105 
and reviewed with the videographer. The resulting video will be used in Aim 5. 
1106 
 
1107 
Aim 5: During the third focus group the women will review the six edited videos and 
1108 
provide feedback on the acceptability of the videos. Acceptability will be measured for 
1109 
each video using a 4-item summative evaluation using a 5-point scale, which will 
1110 
address overall satisfaction, content and language used in each video. Open-ended 
1111 
questions asked by the moderators will capture participants’ thoughts on what their likes 
1112 
and dislikes about the videos. This session will be audiotaped and transcribed.  
1113 
 
1114 
The PI and RA will review the transcribed discussions and the mean scores from each 
1115 
question on the questionnaire will be calculated. 
1116 
 
1117 

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Aim 6: No data will be collected in this aim.  
1118 
 
1119 
10.0 Data and Safety Monitoring 
1120 
During this study, data and safety-monitoring will occur to to ensure the safety of study 
1121 
participants and the validity of data in compliance with the National Institutes of Health 
1122 
(NIH) requirement of Data and Safety Monitoring for Clinical Trials.  The Data and 
1123 
Safety Monitoring for the proposed project has three goals: (1) to insure the safety of 
1124 
the participants; (2) to produce high quality research while considering both risks and 
1125 
benefits.   
1126 
 
1127 
This section outlines essential elements of the Data and Safety Monitoring (DSM) for 
1128 
this study.  
1129 
a) Monitoring the Progress of the Trial and Safety of Participants: This study poses 
1130 
minimal risk to the participants, as it involves getting the participant’s opinions on 
1131 
the use of behavioral counseling and low-impact exercise, walking. Drs. Sharp and 
1132 
Nyenhuis will perform local monitoring of the progress of the trial and the safety of 
1133 
participants.  
1134 
 
1135 
b) Plans for Assuring Compliance with Requirements Regarding the Reporting of 
1136 
Adverse Events (AE): 
1137 
Participants will be given the study office phone number (24-hour coverage) to 
1138 
contact study staff and/or investigators to report adverse events. All adverse events 
1139 
will be reported to the IRB and study sponsor (NIH). 
1140 
  
1141 
Information about adverse events experienced by study participants will be 
1142 
monitored by the following means:  
1143 
• Report given by study participants to study staff, either in person or by telephone.  
1144 
• Report given to study staff by study participants’ family or friends, either in person 
1145 
or by telephone.  
1146 
• Report by the participant’s physician or other health care provider involved in her 
1147 
care.  
1148 
• Report from a hospital or other healthcare facility where the study participant(s) is 
1149 
being treated for the serious adverse event.  
1150 
• Other persons who may have knowledge of such a serious adverse event.  
1151 
 
1152 
Upon receiving a report of a serious adverse event:  
1153 
• The study staff will contact Dr. Nyenhuis (at 312-572-9179) or Dr. Sharp (312-355-
1154 
3569) as soon as possible.  
1155 
• Drs. Nyenhuis or Sharp will complete the Adverse Event Report and submit the 
1156 
completed form to the Human Subjects Committee of the University of Illinois at 
1157 
Chicago and the NIH within 24 hours of learning of the adverse event.  
1158 
• A copy of the adverse event form will be kept in the study file. 
1159 
 
1160 

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Drs. Nyenhuis and Sharp will assess recruitment flow, attendance, retention rates, 
1161 
and AE summaries weekly during team meetings. Data from the focus groups will 
1162 
be recorded and transcribed by a member of the research team for review by Drs. 
1163 
Nyenhuis and Sharp. Procedures will be reviewed to insure that the data collected 
1164 
are collected in a manner consistent with the confidentiality of the participants 
1165 
involved.  
1166 
 
1167 
Monitoring the Progress of the Trial and the Safety of Participants.   
1168 
Overall, the study poses minimal risk to participants.  A safety office will be named and 
1169 
reports will be tendered every quarter to monitor progress and problems.  The report 
1170 
provided to the safety office will including periodic assessments of data quality and 
1171 
timeliness, participant recruitment, accrual and retention, participant risk versus benefit, 
1172 
participant complaints (if any), adverse events, and other factors that can affect study 
1173 
outcomes.  Summaries of enrollment, attendance, and withdrawals will be reviewed.  If 
1174 
we are not meeting our recruitment/retention goals we may consider the following 
1175 
retention methods that have been used by other co-investigators in this patient 
1176 
population such as: 1) Sending notes of appreciation, birthday cards or holiday cards; 2) 
1177 
Small tokens of appreciation. If a participant is unable to provide acceptable 
1178 
accelerometer data (as described above) or is withdrawn from the study, a final letter 
1179 
will be mailed to the participant (See Letter to participants that are withdrawn). The 
1180 
research team will report any problems expressed by participants to the PI either in 
1181 
person or by telephone within 24 hours of the problem.  She will then pass this on to the 
1182 
IRB and other appropriate oversight bodies.  
1183 
 
1184 
Reporting Adverse Events.   
1185 
The safety officer will be immediately notified of any adverse events.  All adverse 
1186 
events will be reported to the Institutional Review Board (IRB). 
1187 
 
1188 
11.0 Statistical Considerations 
1189 
Aim 1: Focus Groups 
1190 
We will randomly select 160 women with the goal of recruiting a random sample of 30 
1191 
women. Participants will be selected to ensure representation of a range of variables 
1192 
including asthma severity, current age and menopausal status. The sample size is 
1193 
determined by the theoretical saturation or the point when no new ideas relevant to the 
1194 
question are obtained, which is generally 1553. However, a minimum of 20 is 
1195 
recommended for illness studies54. This study includes 30 participants in groups of 6-10 
1196 
for focus groups. If redundancy is not noted in the focus group discussion, additional 
1197 
participants will be included until saturation is reached.   
1198 
Qualitative analysis will occur after the focus groups. We will review focus group 
1199 
transcriptions to identify recurring themes especially those focused on barriers and 
1200 
enablers to PA/walking and explore the distribution across the groups by key variables 
1201 
such as asthma severity and age. 
1202 

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Aim 2: Pre-pilot ACTION Intervention 
1203 
One hundred women will be screened and up to 10 women will be selected to 
1204 
participate in the pre-pilot. Participants will be selected to ensure representation of a 
1205 
range of variables including asthma severity, current age and menopausal status. As 
1206 
the goal of this portion of the study is to test run the intervention and inform further 
1207 
refinement of the study methods no specific sample size calculations were performed.  
1208 
 
1209 
Aim 3: Pilot ACTION intervention 
1210 
Eight hundred women will be screened and up to 80 women will be selected to 
1211 
participate in the pilot. Participants will be selected to ensure representation of a range 
1212 
of variables including asthma severity, current age and BMI. Participants will be 
1213 
randomized using REDCap randomization program. As the goal of this portion of the 
1214 
study is to test the feasibility, acceptability and estimate the efficacy of the modified 
1215 
intervention thus no specific sample size calculations were performed.  
1216 
 
1217 
Aims 4 and 5: Adapting Intervention tools 
1218 
We will recruit up to 15 AA women with asthma from our database of ~80 AA women 
1219 
with asthma that have given us permission to contact them for research studies. These 
1220 
women have already been identified as having asthma either through physician 
1221 
diagnosis and/or the use of a validated electronic health record (EHR) algorithm that 
1222 
identifies asthma patients with a high sensitivity and specificity (99% and 96%, 
1223 
respectively)[15, 16]. Potential participants will be contacted and asked screening 
1224 
questions to ensure they are still in our target age range of 18-70 years. Participants will 
1225 
be selected to ensure representation of age ranges. The sample size is determined by 
1226 
the theoretical saturation or the point when no new ideas relevant to the question are 
1227 
obtained, which is generally 15[17].  
1228 
 
1229 
Qualitative analysis will occur after the focus groups. We will review focus group 
1230 
transcriptions to identify recurring themes especially those focused on video adaptation 
1231 
and acceptability of the final product.  
1232 
 
1233 
Aim 6: Dissemination of study findings 
1234 
As no data is collected there will be no statistical analysis performed. 
1235 
 
1236 
12.0 Regulatory Requirements 
1237 
12.1 Informed Consent  
1238 
As Aims 1-3 of this research involves no greater than minimal risk, we will obtain 
1239 
eligibility and interest in participation over the phone or in person. All participants that 
1240 
attend the focus group will provide written informed consent will be obtained prior to 
1241 

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starting the focus group. All participants involved in Aims 2 and 3 of the intervention will 
1242 
provide written informed consent prior to any study procedures taking place.  
1243 
 
1244 
Informed consent will be obtained by key research personnel that have completed 
1245 
training in human subjects research and obtaining informed consent. 
1246 
 
1247 
We request a HIPAA Preparatory to Research, a waiver of informed consent for the 
1248 
identification of potential participants in the recruitment phase of research.  
1249 
 
1250 
This request is based on the following criteria that we will follow: 
1251 
 
1252 
a. Use is sought solely to review protected health information as necessary to 
1253 
perform the asthma algorithm in the UI Health EHR. prepare a research protocol 
1254 
or for similar purposes preparatory to research (in this case identify participants 
1255 
for recruitment); 
1256 
 
1257 
b. No protected health information is to be removed from the covered entity by the 
1258 
researcher in the course of the review and PHI will not be retained long term if 
1259 
patient decide not to participate; and 
1260 
 
1261 
c. The protected health information for which use or access is sought is necessary 
1262 
for the research purposes. 
1263 
 
1264 
The following criteria for the waiver of informed consent for the identification of potential 
1265 
participants in the recruitment phase of the research will be met: 
1266 
 
1267 
a. The recruitment phase of the research involves no more than minimal risk to the 
1268 
participants; 
1269 
b. The waiver of informed consent for the identification of potential participants in the 
1270 
recruitment phase of the research will not adversely affect the rights and welfare 
1271 
of the participants; 
1272 
c. The recruitment phase of the research could not practicably be carried out without 
1273 
the waiver of informed consent for the identification of potential participants in the 
1274 
recruitment phase of the research; and 
1275 
d. If appropriate, the participants will be provided with additional pertinent 
1276 
information after the recruitment phase of the research. 
1277 
 
1278 
A waiver of documentation and an alteration of consent is requested for the eligibility 
1279 
screening portion of the study. 
1280 

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12.2 Subject Confidentiality  
1281 
Each participant will be given information about the purpose of the study and will 
1282 
participate only after having signed the informed consent.  Confidentiality will be 
1283 
maintained by keeping research records in locked file drawers and all data will be 
1284 
maintained on a secured network maintained in the Department of Medicine.  We will 
1285 
use identification numbers to insure confidentiality of the data files.  Once collected, an 
1286 
individual’s data will not be available to anyone other than an authorized person on the 
1287 
proposed project. 
1288 
 
1289 
Participants will receive a thorough introduction to the study preparing them for the 
1290 
nature of the questions that will be asked in the focus group.  Such preparation often 
1291 
decreases the risk for becoming unduly distressed.  If a participant does become 
1292 
distressed, study staff will be trained to respond in a supportive, empathic way and to 
1293 
give the participant the opportunity to take a break.  
1294 
 
1295 
Formal training on data and participant safety is provided to all research staff involved in 
1296 
the data collection process.  All staff and students involved in our research studies sign 
1297 
a confidentiality agreement stating that they are aware that any data they come in 
1298 
contact with is strictly confidential and is not to be discussed outside of the research 
1299 
project.  They also complete the University of Illinois at Chicago online training on 
1300 
Human Subjects Protection (101) and the HIPAA Privacy Act.  
1301 
 
1302 
12.3 Unanticipated Problems 
1303 
Unanticipated problems involving risks to participants or others (including adverse 
1304 
events), will be reported to the UIC IRB and study sponsor (NIH) in a timely manner. 
1305 
1306 

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13.0 References 
1307 
 
1308 
1. 
Pacheco, J.A., et al., A highly specific algorithm for identifying asthma cases and 
1309 
controls for genome-wide association studies. AMIA Annu Symp Proc, 2009. 
1310 
2009: p. 497-501. 
1311 
2. 
Kvale, S., Inter Views: An introduction to qualitative research interviewing. 1996, 
1312 
Thousand Oaks, CA: Sage. 
1313 
3. 
Conrad, P., The experience of illiness: Recent and new directions, in The 
1314 
experience and management of chronic illness, C.P. Roth JA, Editor. 1987, JAI 
1315 
Press: Greenwich, CT. 
1316 
4. 
Charmaz, K., Constructing grounded theory: A practical guide through qualitative 
1317 
analysis. 2006, London: Sage. 
1318 
5. 
S, F., User's Manual for ATLAS.ti 5.0. 2004, Scientific Software Development: 
1319 
Berlin. 
1320 
 
1321 
 
1322 
 
1323 

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APPENDICES 
 
Appendix 1: Asthma Control Questionnaire (ACQ) 
Appendix 2: Asthma Control Test (ACT)  
Appendix 3: EASY Questionnaire 
Appendix 4: Asthma Algorithm 
Appendix 5: Basic Demographics Information  
Appendix 6: Focus Group Guide/Questions 
Appendix 7: Table of study procedures (pre-pilot 7a and pilot 7b) 
Appendix 8: Survey measures  
Appendix 9: Evaluation of group session 
Appendix 10: Summative evaluation of intervention 
Appendix 11: Text message content 
Appendix 12: Focus group guide for adapting intervention tools 
Appendix 13: Video Acceptability measure 
Appendix 14: Sample dissemination newsletters 
Appendix 15: Cover letter/email to accompany dissemination newsletter 
Other documents 
Blank Output from Asthma Algorithm V1 
Sample CRF for REDCAP V1 
Link to videos used in group sessions: 
 https://www.rushu.rush.edu/womens-walking-program 
Link to Asthma Education content: American Lung Association Asthma Basics 
http://www.lung.org/lung-health-and-diseases/lung-disease-lookup/asthma/asthma-
education-advocacy/asthma-basics.html 
Sample participant walking program manual 
Permission to contact health care provider 
Email to UI Health provider for medical clearance 
Participant letter for missed visits 
Participant letter if withdrawn  
 
Recruitment Documents 

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[ACTION intervention] 
Version [19] 
Page 38 of 38 
[3-9-2020] 
Patient Letter  
#1-Focus Groups 
#2-Pre-pilot intervention 
#3- Pilot intervention 
#4- Adapting tools- Focus Groups 
 
Return Postcard 
 
Eligibility Script 
#1-Focus Groups: Phone and in-person 
#2-Pre-pilot intervention: Phone and in-person 
#3-Pilot intervention: Phone and In-person 
#4- Adapting tools- Focus Groups: Phone and in-person 
 
 
Eligibility Screening Form 
#1-Focus Groups 
#2-Pre-pilot intervention 
#3- Pilot intervention 
#4- Adapting tools- Focus Groups 
 
Informed Consent Document 
#1-Focus Groups 
#2-Pre-pilot intervention 
#3- Pilot intervention 
#4- Adapting tools- Focus Groups