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NCT Number: NCT07044388

Coping With Asthma Throughout Life Management Program

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Unable or unwilling to give consent
  • Diagnosis of a psychotic disorder
  • Positive responses to questions regarding suicidality

Treatment and study plan

Coping with asthma through life management program

Behavioral

Participants will complete surveys, learn stress coping strategies, receive asthma education information, and obtain access local community financial resources.

Waitlist Control (CALM)

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Asthma Control Questionnaire (ACQ-6)

    Time frame: 1 week

    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.

  2. Perceived Stress Scale (PSS-10)

    Time frame: 1 month

    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.

  3. Asthma Quality of Life Questionnaire, Marks (AQLQ-M)

    Time frame: 2 weeks

    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.

  4. Number of participants with an asthma exacerbation event

    Time frame: 12 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Isaretta Riley, MD-MPH

CONTACT

[email protected]

919-613-7682

TraNae Gibbs, BS

CONTACT

[email protected]

919-479-0861

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Coping With Asthma Throughout Life Management: CALM Program for African American Adult Patients With Asthma

Acronym: CALM

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 1, 2025
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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