AzTrials
AzTrials

AsthmaACTIONNCT03265665

physicAl aCtiviTy In minOrity womeN With Asthma Intervention

A study testing ACTION Intervention in people with Asthma, run by University of Illinois Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Asthma
What is being tested?
ACTION Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteUnited States
Study dates
1 Oct 2017to 30 Sep 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 15Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Illinois Hospital and Health Sciences System

    Chicago, Illinois, 60612

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Asthma
Being tested
ACTION Intervention, Enhanced usual care
Keywords
walking, African American women, lifestyle
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACTION InterventionBehavioural

    Also called Group sessions

    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.

  • Enhanced usual careOther

    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.

Study groups in NCT03265665
Study groupRoleWhat they receive
ACTION InterventionExperimentalWomen 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.
Receives: Behavioral: ACTION Intervention
Enhanced usual careOtherWomen 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.
Receives: Other: Enhanced usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of Intervention-Recruitment

    The total number of participants recruited and consented in the study.

    Measured: 24 weeks

  2. Feasibility of Intervention-Withdrawals

    Number of participants that withdrew from the study

    Measured: 24 weeks

  3. Feasibility of Lifestyle PA Intervention

    Number of participants that completed 24-week outcomes assessment

    Measured: 24 weeks

  4. 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.

    Measured: 24-weeks

  5. 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.

    Measured: 24-weeks

Secondary outcomes (6)

  1. Light Physical Activity Levels

    as measured by accelerometer and using proprietary Actilife software

    Measured: 24 weeks

  2. 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.

    Measured: 24 weeks

  3. 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.

    Measured: 24 weeks

  4. Daily Step Counts

    as measured by accelerometer

    Measured: 24 weeks

  5. Moderate Physical Activity Levels

    as measured by accelerometer and using proprietary Actilife software

    Measured: 24 weeks

  6. Vigorous Physical Activity Levels

    as measured by accelerometer and using proprietary Actilife software

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2017
  2. Study start1 Oct 2017
  3. Primary completion15 Jun 2019
  4. Study completion30 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03265665
Sponsor's protocol ID
2016-0466
Other IDs
K01HL133370
Acronym
ACTION
Status last verified
Feb 2022
First submitted
17 Aug 2017
Last updated
23 Feb 2022
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing ACTION Intervention in people with Asthma, run by University of Illinois Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Intervention-Recruitment (time frame: 24 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03265665.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in