Asthma
Conditions
Keywords
walking, African American women, lifestyle
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.
Interventions
BEHAVIORALACTION Intervention
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.
OTHEREnhanced usual care
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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Light Physical Activity Levels | 24 weeks | as measured by accelerometer and using proprietary Actilife software |
| Vigorous 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. |
| 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. |
| Daily Step Counts | 24 weeks | as measured by accelerometer |
| Moderate Physical Activity Levels | 24 weeks | as measured by accelerometer and using proprietary Actilife software |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
ACTION Intervention: 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. | 25 |
| 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.
Enhanced usual care: 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. | 28 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 24-week Data Collection | Lost to Follow-up | 4 | 5 |
| 24-week Data Collection | Withdrawal by Subject | 2 | 2 |
| 36-week Data Collection | Lost to Follow-up | 6 | 8 |
Baseline characteristics
| Characteristic | ACTION Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 42.87 years STANDARD_DEVIATION 11 | 43.84 years STANDARD_DEVIATION 14 | 43.38 years STANDARD_DEVIATION 12 |
| Asthma control Questionnaire(ACQ-6) | 1.69 units on a scale STANDARD_DEVIATION 0.98 | 1.83 units on a scale STANDARD_DEVIATION 0.86 | 1.76 units on a scale STANDARD_DEVIATION 0.91 |
| Asthma quality of life (AQLQ) | 4.66 units on a scale STANDARD_DEVIATION 1.2 | 4.6 units on a scale STANDARD_DEVIATION 0.91 | 4.63 units on a scale STANDARD_DEVIATION 1.03 |
| Body Mass Index | 35.97 kg/m^2 STANDARD_DEVIATION 7 | 36.86 kg/m^2 STANDARD_DEVIATION 12 | 36.44 kg/m^2 STANDARD_DEVIATION 10 |
| Daily steps | 4737.97 steps/day STANDARD_DEVIATION 1726.55 | 4958.94 steps/day STANDARD_DEVIATION 2241.91 | 4853.98 steps/day STANDARD_DEVIATION 1991.44 |
| Emergency Department visit(s) in the past 6 mo (yes) | 5 Participants | 7 Participants | 12 Participants |
| Forced Expiratory Volume in 1 second | 2.06 Liters STANDARD_DEVIATION 0.68 | 2.04 Liters STANDARD_DEVIATION 0.58 | 2.04 Liters STANDARD_DEVIATION 0.63 |
| Forced Expiratory Volume in 1 second % predicted | 58.64 % predicted STANDARD_DEVIATION 29 | 66.85 % predicted STANDARD_DEVIATION 24 | 62.74 % predicted STANDARD_DEVIATION 27 |
| Household Income (<$30,000/year) | 17 Participants | 15 Participants | 32 Participants |
| Insurance status (medicare/medicaid/medical assistance) | 17 Participants | 20 Participants | 37 Participants |
| Light Physical Activity | 576.86 minutes/day STANDARD_DEVIATION 59.92 | 272.77 minutes/day STANDARD_DEVIATION 62.01 | 274.17 minutes/day STANDARD_DEVIATION 70.96 |
| Marital status (Single/divorced/widowed) | 23 Participants | 24 Participants | 47 Participants |
| Moderate Physical Activity | 15.78 minutes/day STANDARD_DEVIATION 18.3 | 16.67 minutes/day STANDARD_DEVIATION 16.56 | 16.23 minutes/day STANDARD_DEVIATION 16.74 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 25 Participants | 28 Participants | 53 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 25 Participants | 28 Participants | 53 Participants |
| Sex: Female, Male Female | 25 Participants | 28 Participants | 53 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Unscheduled office visits in past 6 mo (Yes) | 8 Participants | 5 Participants | 13 Participants |
| Vigorous Physical Activity | 0.63 minutes/day STANDARD_DEVIATION 2.48 | 0.19 minutes/day STANDARD_DEVIATION 0.76 | 0.34 minutes/day STANDARD_DEVIATION 1.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 28 |
| other Total, other adverse events | 2 / 25 | 1 / 28 |
| serious Total, serious adverse events | 0 / 25 | 0 / 28 |
Outcome results
Primary
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
Population: Acceptability of the intervention was measured in only intervention participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Screen Participants | Acceptability of Lifestyle PA Intervention | 6.88 units on a scale | Standard Deviation 0.33 |
Primary
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
Population: Intervention satisfaction was only collected in those randomized to intervention group.It is not possible to summarize the data collected from the open-ended questions in tabular form.
Primary
Feasibility of Intervention-Recruitment
The total number of participants recruited and consented in the study.
Time frame: 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Screen Participants | Feasibility of Intervention-Recruitment | 53 participants |
Primary
Feasibility of Intervention-Withdrawals
Number of participants that withdrew from the study
Time frame: 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screen Participants | Feasibility of Intervention-Withdrawals | 2 Participants |
| Enhanced Usual Care | Feasibility of Intervention-Withdrawals | 2 Participants |
Primary
Feasibility of Lifestyle PA Intervention
Number of participants that completed 24-week outcomes assessment
Time frame: 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screen Participants | Feasibility of Lifestyle PA Intervention | 19 Participants |
| Enhanced Usual Care | Feasibility of Lifestyle PA Intervention | 21 Participants |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Screen Participants | Asthma Control Questionnaire (ACQ-6) | 1.28 score on a scale | Standard Deviation 1.03 |
| Enhanced Usual Care | Asthma Control Questionnaire (ACQ-6) | 1.87 score on a scale | Standard Deviation 0.99 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Screen Participants | Asthma Quality of Life Questionnaire (AQLQ) | 5.24 score on a scale | Standard Deviation 1.35 |
| Enhanced Usual Care | Asthma Quality of Life Questionnaire (AQLQ) | 4.70 score on a scale | Standard Deviation 1.06 |
Secondary
Daily Step Counts
as measured by accelerometer
Time frame: 24 weeks
Population: The number of participants does not equal 19 (Intervention) and 21 (EUC) as we lost a number of accelerometers in the mail or did not have adequate amount of data (A minimum of 10 hours of wear time for at least three days over a 1 week period).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Screen Participants | Daily Step Counts | 4372.73 steps/day | Standard Deviation 1884.9 |
| Enhanced Usual Care | Daily Step Counts | 5196.32 steps/day | Standard Deviation 1763.58 |
Secondary
Light Physical Activity Levels
as measured by accelerometer and using proprietary Actilife software
Time frame: 24 weeks
Population: The number of participants does not equal 19 (Intervention) and 21 (EUC) as we lost a number of accelerometers in the mail or did not have adequate amount of data (A minimum of 10 hours of wear time for at least three days over a 1 week period).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Screen Participants | Light Physical Activity Levels | 567.13 minutes per day | Standard Deviation 79.99 |
| Enhanced Usual Care | Light Physical Activity Levels | 278.66 minutes per day | Standard Deviation 89.43 |
Secondary
Moderate Physical Activity Levels
as measured by accelerometer and using proprietary Actilife software
Time frame: 24 weeks
Population: The number of participants does not equal 19 (Intervention) and 21 (EUC) as we lost a number of accelerometers in the mail or did not have adequate amount of data (A minimum of 10 hours of wear time for at least three days over a 1 week period).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Screen Participants | Moderate Physical Activity Levels | 16.63 minutes per day | Standard Deviation 23.67 |
| Enhanced Usual Care | Moderate Physical Activity Levels | 18.07 minutes per day | Standard Deviation 13.72 |
Secondary
Vigorous Physical Activity Levels
as measured by accelerometer and using proprietary Actilife software
Time frame: 24 weeks
Population: The number of participants does not equal 19 (Intervention) and 21 (EUC) as we lost a number of accelerometers in the mail or did not have adequate amount of data (A minimum of 10 hours of wear time for at least three days over a 1 week period).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Screen Participants | Vigorous Physical Activity Levels | 0.37 minutes per day | Standard Deviation 1.28 |
| Enhanced Usual Care | Vigorous Physical Activity Levels | 1.14 minutes per day | Standard Deviation 3.03 |