An interventional study of ACTION Intervention and Enhanced usual care in Asthma, sponsored by University of Illinois at Chicago. Completed at 1 site in United States. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-02-23.
Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Treatment
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.
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.
Inclusion Criteria:
Exclusion Criteria: • Plans to relocate outside of the Chicagoland area during the study period.
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
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
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.
Also known as: Group sessions
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.
Feasibility of Intervention-Recruitment
The total number of participants recruited and consented in the study.
Time frame: 24 weeks
Feasibility of Intervention-Withdrawals
Number of participants that withdrew from the study
Time frame: 24 weeks
Feasibility of Lifestyle PA Intervention
Number of participants that completed 24-week outcomes assessment
Time frame: 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.
Time frame: 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.
Time frame: 24-weeks
Light Physical Activity Levels
as measured by accelerometer and using proprietary Actilife software
Time frame: 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.
Time frame: 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.
Time frame: 24 weeks
Daily Step Counts
as measured by accelerometer
Time frame: 24 weeks
Moderate Physical Activity Levels
as measured by accelerometer and using proprietary Actilife software
Time frame: 24 weeks
Vigorous Physical Activity Levels
as measured by accelerometer and using proprietary Actilife software
Time frame: 24 weeks
| Milestone | ACTION Intervention | Enhanced Usual Care |
|---|---|---|
| Started | 25 | 28 |
| Completed | 19 | 21 |
| Not completed | 6 | 7 |
| Withdrew: Withdrawal by subject | 2 | 2 |
| Withdrew: Lost to follow-up | 4 | 5 |
| Milestone | ACTION Intervention | Enhanced Usual Care |
|---|---|---|
| Started | 23 | 26 |
| Completed | 17 | 18 |
| Not completed | 6 | 8 |
| Withdrew: Lost to follow-up | 6 | 8 |
The total number of participants recruited and consented in the study.
| participants | Screen Participants |
|---|---|
| Feasibility of Intervention-Recruitment | 53 |
Number of participants that withdrew from the study
| Participants | ACTION Intervention | Enhanced Usual Care |
|---|---|---|
| Feasibility of Intervention-Withdrawals | 2 | 2 |
Number of participants that completed 24-week outcomes assessment
| Participants | ACTION Intervention | Enhanced Usual Care |
|---|---|---|
| Feasibility of Lifestyle PA Intervention | 19 | 21 |
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.
| units on a scale | ACTION Intervention | Enhanced Usual Care |
|---|---|---|
| Acceptability of Lifestyle PA Intervention | 6.88 ± 0.33 | — |
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.
No measurements were reported for this outcome.
as measured by accelerometer and using proprietary Actilife software
| minutes per day | ACTION Intervention | Enhanced Usual Care |
|---|---|---|
| Light Physical Activity Levels | 567.13 ± 79.99 | 278.66 ± 89.43 |
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.
| score on a scale | ACTION Intervention | Enhanced Usual Care |
|---|---|---|
| Asthma Quality of Life Questionnaire (AQLQ) | 5.24 ± 1.35 | 4.70 ± 1.06 |
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.
| score on a scale | ACTION Intervention | Enhanced Usual Care |
|---|---|---|
| Asthma Control Questionnaire (ACQ-6) | 1.28 ± 1.03 | 1.87 ± 0.99 |
as measured by accelerometer
| steps/day | ACTION Intervention | Enhanced Usual Care |
|---|---|---|
| Daily Step Counts | 4372.73 ± 1884.90 | 5196.32 ± 1763.58 |
as measured by accelerometer and using proprietary Actilife software
| minutes per day | ACTION Intervention | Enhanced Usual Care |
|---|---|---|
| Moderate Physical Activity Levels | 16.63 ± 23.67 | 18.07 ± 13.72 |
as measured by accelerometer and using proprietary Actilife software
| minutes per day | ACTION Intervention | Enhanced Usual Care |
|---|---|---|
| Vigorous Physical Activity Levels | 0.37 ± 1.28 | 1.14 ± 3.03 |
Collected over 36 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ACTION Intervention | 0/25 (0%) | 0/25 (0%) | 2/25 (8%) |
| Enhanced Usual Care | 0/28 (0%) | 0/28 (0%) | 1/28 (3.6%) |
| Event | ACTION Intervention | Enhanced Usual Care |
|---|---|---|
| skin rashSkin and subcutaneous tissue disorders | 2/25 | 1/28 |
| Age, Continuous(years) | ACTION Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| Mean | 42.87 ± 11 | 43.84 ± 14 | 43.38 ± 12 |
| Sex: Female, Male(Participants) | ACTION Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| Female | 25 | 28 | 53 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | ACTION Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 25 | 28 | 53 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | ACTION Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| United States | 25 | 28 | 53 |
| Body Mass Index(kg/m^2) | ACTION Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| Mean | 35.97 ± 7 | 36.86 ± 12 | 36.44 ± 10 |
| Household Income (<$30,000/year)(Participants) | ACTION Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| Count of participants | 17 | 15 | 32 |
| Insurance status (medicare/medicaid/medical assistance)(Participants) | ACTION Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| Count of participants | 17 | 20 | 37 |
| Marital status (Single/divorced/widowed)(Participants) | ACTION Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| Count of participants | 23 | 24 | 47 |
10 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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University of Illinois at Chicago