AsthmaCALMNCT07044388
Coping With Asthma Throughout Life Management Program
A study testing Coping with asthma through life management program in people with Asthma and Stress, run by Duke University.
Trial summary
The purpose of this study is to determine if the Coping with Asthma through Life Management (CALM) intervention, designed to help Black adult with asthma cope with stress, is feasible and acceptable. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Coping with asthma through life management program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least the age of 18
- Self identify as Black/African-American
- Self-report current asthma diagnosis
- Asthma must be persistent (Prescribed an inhaled corticosteroid (alone or in combination)
- Asthma must be uncontrolled (≥1 exacerbation in the past years OR Asthma Control Questionnaire > 0.75)
- Have moderate-high stress (Perceived Stress Scale ≥ 14)
- Presented at any Primary Care clinic in the past 3 years.
Who cannot join
- Unable or unwilling to give consent
- Diagnosis of a psychotic disorder
- Positive responses to questions regarding suicidality
About this study
Official title: Coping With Asthma Throughout Life Management: CALM Program for African American Adult Patients With Asthma
The purpose of this study is to determine if the Coping with Asthma through Life Management (CALM) intervention, designed to help Black adult with asthma cope with stress, is feasible and acceptable.
Read the detailed description
Asthma medication nonadherence is a major contributor to asthma morbidity and mortality in Black adults. Black adults with asthma reported that increased psychosocial stress (e.g., perceived discrimination, job stress, caregiver burden), health-related stress (e.g., concern about asthma control), and economic stress (e.g., economic strain) were barriers to asthma medication adherence and control. The study's hypothesis is that CALM, targeting multiple stressors specifically faced by Black adults with asthma, will be feasibly implemented in a health system, will be acceptable to program participants, and will be a potentially effective intervention to improve asthma medication adherence and asthma control.
- Being tested
- Coping with asthma through life management program, Waitlist Control (CALM)
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coping with asthma through life management programBehavioural
Participants will complete surveys, learn stress coping strategies, receive asthma education information, and obtain access local community financial resources.
Waitlist Control (CALM)Behavioural
Participants in this group will complete surveys but will not receive the CALM intervention. Upon completing the study after 12 weeks they will be able to complete the program if they would like the resources/materials to learn healthy stress coping strategies, asthma health education, and access to financial resources.
| Study group | Role | What they receive |
|---|---|---|
| Randomized | Experimental | Group will receive intervention method Receives: Behavioral: Coping with asthma through life management program |
| Waitlist Control Group | Other | Participants will receive no intervention (control) during the trial. However, after the study is completed, they will have the option to receive intervention. Receives: Behavioral: Waitlist Control (CALM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention Measure (FIM)
The FIM has four items and the total score ranges from 4 to 20, where a higher score indicates greater feasibility.
Measured: 12 weeks
Acceptability of Intervention Measure (AIM)
The AIM has four items and the total score ranges from 4 to 20, where a higher score indicates greater acceptability.
Measured: 12 Weeks
Intervention Appropriateness Measure (IAM)
The IAM has four items and the total score ranges from 4 to 20, where a higher score indicates greater appropriateness.
Measured: 12 Weeks
Secondary outcomes (4)
Asthma Control Questionnaire (ACQ-6)
The ACQ-6 is a six-question questionnaire used to assess asthma control, focusing on symptoms and rescue medication use. Scores range from 0 to 6, with lower scores indicating better asthma control. A score of 1.5 or higher suggests poorly controlled asthma.
Measured: 1 week
Perceived Stress Scale (PSS-10)
The PSS-10 is a 10-item questionnaire that evaluates the degree to which an individual has perceived life as unpredictable, uncontrollable, and overloading over the previous month. Scores range from 0 to 40, with higher scores indicating higher levels of perceived stress.
Measured: 1 month
Asthma Quality of Life Questionnaire, Marks (AQLQ-M)
The AQLQ-M is a 20-item self-administered questionnaire to measure quality of life in adults with asthma. Scores range from 20 to 100, with higher scores indicating a greater negative impact of asthma.
Measured: 2 weeks
Number of participants with an asthma exacerbation event
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start15 Jun 2026 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Why it stopped: PI departure from institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isaretta Riley, MD-MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044388
- Sponsor's protocol ID
- Pro00114349
- Acronym
- CALM
- Status last verified
- Aug 2026
- First submitted
- 23 Jun 2025
- Last updated
- 7 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coping With Asthma Throughout Life Management: CALM Program for African American Adult Patients With Asthma
- ClinicalTrials.gov ID
- NCT07044388
- Acronym / sponsor ID
- CALM / Pro00114349
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI departure from institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if the Coping with Asthma through Life Management (CALM) intervention, designed to help Black adult with asthma cope with stress, is feasible and acceptable.
Detailed description
Asthma medication nonadherence is a major contributor to asthma morbidity and mortality in Black adults. Black adults with asthma reported that increased psychosocial stress (e.g., perceived discrimination, job stress, caregiver burden), health-related stress (e.g., concern about asthma control), and economic stress (e.g., economic strain) were barriers to asthma medication adherence and control. The study's hypothesis is that CALM, targeting multiple stressors specifically faced by Black adults with asthma, will be feasibly implemented in a health system, will be acceptable to program participants, and will be a potentially effective intervention to improve asthma medication adherence and asthma control.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Randomized | Experimental | Behavioral: Coping with asthma through life management programGroup will receive intervention method |
| Waitlist Control Group | Other | Behavioral: Waitlist Control (CALM)Participants will receive no intervention (control) during the trial. However, after the study is completed, they will have the option to receive intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least the age of 18
- Self identify as Black/African-American
- Self-report current asthma diagnosis
- Asthma must be persistent (Prescribed an inhaled corticosteroid (alone or in combination)
- Asthma must be uncontrolled (≥1 exacerbation in the past years OR Asthma Control Questionnaire > 0.75)
Key exclusion criteria (3 listed)
- Unable or unwilling to give consent
- Diagnosis of a psychotic disorder
- Positive responses to questions regarding suicidality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coping with asthma through life management programParticipants will complete surveys, learn stress coping strategies, receive asthma education information, and obtain access local community financial resources. | Behavioural | Randomized |
| Waitlist Control (CALM)Participants in this group will complete surveys but will not receive the CALM intervention. Upon completing the study after 12 weeks they will be able to complete the program if they would like the resources/materials to learn healthy stress coping strategies, asthma health education, and access to financial resources. | Behavioural | Waitlist Control Group |
Primary outcome
Feasibility of Intervention Measure (FIM)
Time frame: 12 weeks
The FIM has four items and the total score ranges from 4 to 20, where a higher score indicates greater feasibility.
Acceptability of Intervention Measure (AIM)
Time frame: 12 Weeks
The AIM has four items and the total score ranges from 4 to 20, where a higher score indicates greater acceptability.
Intervention Appropriateness Measure (IAM)
Time frame: 12 Weeks
The IAM has four items and the total score ranges from 4 to 20, where a higher score indicates greater appropriateness.
4 secondary outcomes
Asthma Control Questionnaire (ACQ-6)
Time frame: 1 week
Perceived Stress Scale (PSS-10)
Time frame: 1 month
Asthma Quality of Life Questionnaire, Marks (AQLQ-M)
Time frame: 2 weeks
Number of participants with an asthma exacerbation event
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isaretta Riley, MD-MPH principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A study testing Coping with asthma through life management program in people with Asthma and Stress, run by Duke University.
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 7 inclusion and 3 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: withdrawn, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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 Measure (FIM) (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2026.