Back to resultsphysicAl aCtiviTy In minOrity womeN With Asthma Intervention (ACTION)
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACTION Intervention
Enhanced usual care
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring walking, African American women, lifestyle
Eligibility Criteria
Inclusion Criteria:
- Self-identify as female and black or AA
- Age 18-70
- Sub-optimally controlled persistent asthma based on Asthma Control Test (ACT <20)
- Wiling to enroll and provide written-informed consent
- Willing to be randomly assigned to treatment or control group
Exclusion Criteria: • Plans to relocate outside of the Chicagoland area during the study period.
- Unable to ambulate without human assistance (ie. use of a wheelchair, scooter)
- History of significant mental illness (e.g. uncontrolled bipolar disorder, psychoses)
- Currently pregnant, planning to become pregnant over the next 3 months
- Diagnosis of COPD (emphysema or chronic bronchitis) suggested by patient report of doctor diagnosis or smoking history (>20 pack years)
- Poorly controlled high blood pressure (BP >180/100 at baseline visit)
- Family/household member of another study participant or staff member
- Inability to speak, read or understand English;
- Investigator discretion for safety or protocol adherence reasons
- Participation in ACTION focus groups (Aim 1) or pre-pilot (Aim 2) of the study
Sites / Locations
- University of Illinois Hospital and Health Sciences System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
ACTION Intervention
Enhanced usual care
Arm Description
Women in the ACTION intervention will attend 1 asthma education/physical activity session and 5 group sessions in community location convenient to participants during the adoptive phase (24-weeks) and 1 group session during the maintenance phase (12-weeks). Each session will last approximately 2 hours. Participants will be given Fitbit Charge HR to monitor their daily steps and will be sent motivational, educational and reminder text messages up to 3 times per week.
Women in the Enhanced usual care arm will attend 1 asthma education/physical activity session and be given a Fitbit Charge HR to monitor their daily steps. They will be given a static step goal to achieve. Only reminder text messages for data collection visits will be sent.
Outcomes
Primary Outcome Measures
Feasibility of Intervention-Recruitment
The total number of participants recruited and consented in the study.
Feasibility of Intervention-Withdrawals
Number of participants that withdrew from the study
Feasibility of Lifestyle PA Intervention
Number of participants that completed 24-week outcomes assessment
Acceptability of Lifestyle PA Intervention
Unabbreviated scale title: ACTION Satisfaction Scale. Acceptability was measured using a 7-point Likert scale with 1 representing not satisfied and 7 representing very satisfied. Higher scores mean more satisfied with the intervention. The range is from 1-7.
Acceptability of Lifestyle PA Intervention-Qualitative Data
Intervention participants were asked open-ended questions about their satisfaction with the study. Responses were written down by the participant and data collector. It is not possible to summarize the data collected from the open-ended questions in tabular form as it is qualitative data.
Secondary Outcome Measures
Light Physical Activity Levels
as measured by accelerometer and using proprietary Actilife software
Asthma Quality of Life Questionnaire (AQLQ)
The Asthma Quality of Life Questionnaire (AQLQ) is a 32-item questionnaire. It has 4 domains: symptoms (12 items), activity limitation (6 generic and 5 patient-specific items), emotional function (5 items), and environmental stimuli (4 items). The AQLQ items are each scored on a 7-point Likert scale, with 1 representing maximal impairment and 7 representing no impairment. Scores range 1-7, with higher scores indicating better quality of life. A total score was calculated by summing all responses for each question and then dividing by the number of items in the questionnaire (n=32). Subdomains were not reported/used.
Asthma Control Questionnaire (ACQ-6)
Unabbreviated scale title: Asthma control questionnaire (ACQ) The ACQ score correlates with a measure of asthma control based on the GINA/NIH criteria. ACQ includes 6 questions on symptoms, activity limitation and beta2-agonist use. Each question is scored from 0 to 6 with the total score being the average of the questions. The ACQ score ranges between 0 (well controlled) and 6 (extremely poorly controlled). Recent studies show that a score of 1.5 or more on the 6-item Asthma Control Questionnaire (ACQ) indicates that a patient has inadequate asthma control.Higher scores mean poorer asthma control.
Daily Step Counts
as measured by accelerometer
Moderate Physical Activity Levels
as measured by accelerometer and using proprietary Actilife software
Vigorous Physical Activity Levels
as measured by accelerometer and using proprietary Actilife software
Full Information
NCT ID
NCT03265665
First Posted
August 17, 2017
Last Updated
February 18, 2022
Sponsor
University of Illinois at Chicago
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT03265665
Brief Title
physicAl aCtiviTy In minOrity womeN With Asthma Intervention
Acronym
ACTION
Official Title
ACTION: physicAl aCtiviTy In minOrity womeN With Asthma Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
June 15, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The ACTION intervention: physicAl aCtiviTy In minOrity womeN with asthma is a 3lifestyle physical activity intervention refined to be applicable for sedentary African American (AA) women with asthma. The main outcome of this study is to test the feasibility, acceptability and estimate the efficacy of the ACTION intervention in a randomized controlled pilot of 80 AA women with asthma within a pragmatic community setting at 24-weeks.
Detailed Description
Asthma is a highly prevalent chronic disease that disproportionately impacts African American (AA) women. AA women have poorer asthma-related quality of life and higher rates of asthma exacerbations, healthcare utilization and mortality compared to Caucasian women. Further, AA women are less physically active than any other subgroup of adults, which may help explain the asthma health disparities, found between AA and Caucasian women. Physical inactivity among individuals with asthma is associated with poor asthma control and respiratory function, greater health care utilization, and poorer quality of life. Given the connection between poor asthma outcomes and physical inactivity, addressing physical activity (PA) among sedentary AA women with asthma is imperative. Physical activity demonstrated improvement in asthma outcomes specifically asthma control, quality of life and healthcare utilization. Despite these benefits, fewer than 25% of AA women with asthma engage in regular physical activity. The ACTION intervention: physicAl aCtiviTy In minOrity womeN with asthma is a lifestyle PA intervention refined to be applicable for sedentary AA women with asthma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
walking, African American women, lifestyle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ACTION Intervention
Arm Type
Experimental
Arm Description
Women in the ACTION intervention will attend 1 asthma education/physical activity session and 5 group sessions in community location convenient to participants during the adoptive phase (24-weeks) and 1 group session during the maintenance phase (12-weeks). Each session will last approximately 2 hours. Participants will be given Fitbit Charge HR to monitor their daily steps and will be sent motivational, educational and reminder text messages up to 3 times per week.
Arm Title
Enhanced usual care
Arm Type
Other
Arm Description
Women in the Enhanced usual care arm will attend 1 asthma education/physical activity session and be given a Fitbit Charge HR to monitor their daily steps. They will be given a static step goal to achieve. Only reminder text messages for data collection visits will be sent.
Intervention Type
Behavioral
Intervention Name(s)
ACTION Intervention
Other Intervention Name(s)
Group sessions
Intervention Description
The intervention is based on the Women's Lifestyle Physical Activity Program, a culturally sensitive lifestyle physical activity intervention for African American (AA) women. There are 2 phases to the intervention: Adoptive (24 weeks) and Maintenance (12 weeks). 3 motivational/reminder texts will be made each week during the adoption phase. 5 Group sessions(adoptive): Participants will be given individualized step goals, watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking. 1 Group session (maintenance): watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking, reinforce barriers and facilitators to walking. An interventionist will lead a discussion on role-modeling and encouraging problem solving. Each intervention group will have 10 women with 1 interventionist. Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.
Intervention Type
Other
Intervention Name(s)
Enhanced usual care
Intervention Description
Participants will attend 1 two hour asthma education/physical activity session at community location near them. Participants will review basic asthma topics in a didactic session and will include exercising with asthma and exercise-induced asthma. Participants will be given Fitbit and provided instructions on how to use it. Participants may receive 2 newsletters with information on asthma and reminder texts regarding data collection visits.
Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.
Primary Outcome Measure Information:
Title
Feasibility of Intervention-Recruitment
Description
The total number of participants recruited and consented in the study.
Time Frame
24 weeks
Title
Feasibility of Intervention-Withdrawals
Description
Number of participants that withdrew from the study
Time Frame
24 weeks
Title
Feasibility of Lifestyle PA Intervention
Description
Number of participants that completed 24-week outcomes assessment
Time Frame
24 weeks
Title
Acceptability of Lifestyle PA Intervention
Description
Unabbreviated scale title: ACTION Satisfaction Scale. Acceptability was measured using a 7-point Likert scale with 1 representing not satisfied and 7 representing very satisfied. Higher scores mean more satisfied with the intervention. The range is from 1-7.
Time Frame
24-weeks
Title
Acceptability of Lifestyle PA Intervention-Qualitative Data
Description
Intervention participants were asked open-ended questions about their satisfaction with the study. Responses were written down by the participant and data collector. It is not possible to summarize the data collected from the open-ended questions in tabular form as it is qualitative data.
Time Frame
24-weeks
Secondary Outcome Measure Information:
Title
Light Physical Activity Levels
Description
as measured by accelerometer and using proprietary Actilife software
Time Frame
24 weeks
Title
Asthma Quality of Life Questionnaire (AQLQ)
Description
The Asthma Quality of Life Questionnaire (AQLQ) is a 32-item questionnaire. It has 4 domains: symptoms (12 items), activity limitation (6 generic and 5 patient-specific items), emotional function (5 items), and environmental stimuli (4 items). The AQLQ items are each scored on a 7-point Likert scale, with 1 representing maximal impairment and 7 representing no impairment. Scores range 1-7, with higher scores indicating better quality of life. A total score was calculated by summing all responses for each question and then dividing by the number of items in the questionnaire (n=32). Subdomains were not reported/used.
Time Frame
24 weeks
Title
Asthma Control Questionnaire (ACQ-6)
Description
Unabbreviated scale title: Asthma control questionnaire (ACQ) The ACQ score correlates with a measure of asthma control based on the GINA/NIH criteria. ACQ includes 6 questions on symptoms, activity limitation and beta2-agonist use. Each question is scored from 0 to 6 with the total score being the average of the questions. The ACQ score ranges between 0 (well controlled) and 6 (extremely poorly controlled). Recent studies show that a score of 1.5 or more on the 6-item Asthma Control Questionnaire (ACQ) indicates that a patient has inadequate asthma control.Higher scores mean poorer asthma control.
Time Frame
24 weeks
Title
Daily Step Counts
Description
as measured by accelerometer
Time Frame
24 weeks
Title
Moderate Physical Activity Levels
Description
as measured by accelerometer and using proprietary Actilife software
Time Frame
24 weeks
Title
Vigorous Physical Activity Levels
Description
as measured by accelerometer and using proprietary Actilife software
Time Frame
24 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
The focus population for this study is sedentary African-American (AA) women with asthma. All participants included in the study will self-identify themselves as female and AA. This study population was chosen as AA women are disproportionately impacted by physical inactivity and asthma compared to Caucasian men and women and AA men.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Self-identify as female and black or AA
Age 18-70
Sub-optimally controlled persistent asthma based on Asthma Control Test (ACT <20)
Wiling to enroll and provide written-informed consent
Willing to be randomly assigned to treatment or control group
Exclusion Criteria: • Plans to relocate outside of the Chicagoland area during the study period.
Unable to ambulate without human assistance (ie. use of a wheelchair, scooter)
History of significant mental illness (e.g. uncontrolled bipolar disorder, psychoses)
Currently pregnant, planning to become pregnant over the next 3 months
Diagnosis of COPD (emphysema or chronic bronchitis) suggested by patient report of doctor diagnosis or smoking history (>20 pack years)
Poorly controlled high blood pressure (BP >180/100 at baseline visit)
Family/household member of another study participant or staff member
Inability to speak, read or understand English;
Investigator discretion for safety or protocol adherence reasons
Participation in ACTION focus groups (Aim 1) or pre-pilot (Aim 2) of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharmilee M Nyenhuis, MD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois Hospital and Health Sciences System
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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