physicAl aCtiviTy In minOrity womeN With Asthma Intervention (ACTION)

University of Illinois

Status: Completed

Conditions: Asthma

Treatments: Other: Enhanced usual care; Behavioral: ACTION Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03265665

2016-0466 (Other Identifier)

K01HL133370 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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53 participants in 2 patient groups

ACTION Intervention

Experimental group

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.

Treatment:

Behavioral: ACTION Intervention

Enhanced usual care

Other group

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.

Treatment:

Other: Enhanced usual care