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WithdrawnNCT07044388CALMUpdated Aug 7, 2026

Coping With Asthma Throughout Life Management Program

An interventional study of Coping with asthma through life management program and Waitlist Control (CALM) in Asthma and Stress, sponsored by Duke University. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by Duke University · Not applicable, Interventional, and Supportive care

Why this study was withdrawn
PI departure from institution
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Asthma
  • Stress

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03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

Browse Asthma studies →

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Unable or unwilling to give consent
  • Diagnosis of a psychotic disorder
  • Positive responses to questions regarding suicidality
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Randomized

    Group will receive intervention method

    Behavioral: Coping with asthma through life management program

  • Other
    Waitlist Control Group

    Participants will receive no intervention (control) during the trial. However, after the study is completed, they will have the option to receive intervention.

    Behavioral: Waitlist Control (CALM)

Interventions

  • BehavioralCoping with asthma through life management program

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

  • BehavioralWaitlist 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 weeks

  2. 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.

    Time frame: 12 Weeks

  3. 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.

    Time frame: 12 Weeks

Secondary outcomes

  1. 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.

    Time frame: 1 week

  2. 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.

    Time frame: 1 month

  3. 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.

    Time frame: 2 weeks

  4. Number of participants with an asthma exacerbation event

    Time frame: 12 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07044388
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Jul 1, 2025
Start date
Jun 15, 2026 (estimated)
Primary completion
Jul 30, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Aug 7, 2026

Study contacts

Isaretta Riley, MD-MPH
principal investigator · Duke University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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