physicAl aCtiviTy In minOrity womeN With Asthma Intervention

Not Applicable

Completed

Conditions: Asthma

Interventions: Other: Enhanced usual care
Behavioral: ACTION Intervention

Registration Number: NCT03265665

Lead Sponsor: University of Illinois at Chicago

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 53

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced usual care	Enhanced usual care	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.
ACTION Intervention	ACTION Intervention	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of Intervention-Recruitment	24 weeks	The total number of participants recruited and consented in the study.
Feasibility of Intervention-Withdrawals	24 weeks	Number of participants that withdrew from the study
Feasibility of Lifestyle PA Intervention	24 weeks	Number of participants that completed 24-week outcomes assessment
Acceptability of Lifestyle PA Intervention	24-weeks	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	24-weeks	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

Name	Time	Method
Light Physical Activity Levels	24 weeks	as measured by accelerometer and using proprietary Actilife software
Moderate Physical Activity Levels	24 weeks	as measured by accelerometer and using proprietary Actilife software
Asthma Quality of Life Questionnaire (AQLQ)	24 weeks	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.
Daily Step Counts	24 weeks	as measured by accelerometer
Asthma Control Questionnaire (ACQ-6)	24 weeks	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.
Vigorous Physical Activity Levels	24 weeks	as measured by accelerometer and using proprietary Actilife software