physicAl aCtiviTy In minOrity womeN With Asthma Intervention

Study Overview
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Brief Summary
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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
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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.

Official Title
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ACTION: physicAl aCtiviTy In minOrity womeN With Asthma Intervention

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: ACTION Intervention
* Other: Enhanced usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACTION Intervention<br>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. | Behavioral: ACTION Intervention<br>* 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.<br>* Other names: Group sessions;|
| Other: Enhanced usual care<br>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. | Other: Enhanced usual care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Intervention-Recruitment | The total number of participants recruited and consented in the study. | 24 weeks | 
| Feasibility of Intervention-Withdrawals | Number of participants that withdrew from the study | 24 weeks | 
| Feasibility of Lifestyle PA Intervention | Number of participants that completed 24-week outcomes assessment | 24 weeks | 
| 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. | 24-weeks | 
| 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. | 24-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Light Physical Activity Levels | as measured by accelerometer and using proprietary Actilife software | 24 weeks | 
| 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. | 24 weeks | 
| 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. | 24 weeks | 
| Daily Step Counts | as measured by accelerometer | 24 weeks | 
| Moderate Physical Activity Levels | as measured by accelerometer and using proprietary Actilife software | 24 weeks | 
| Vigorous Physical Activity Levels | as measured by accelerometer and using proprietary Actilife software | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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walking, African American women, lifestyle