Coping With Asthma Throughout Life Management Program (CALM)

March 19, 2026 updated by: Duke University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Randomized
Group will receive intervention method
Behavioral: Coping 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.
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks
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.
12 Weeks
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.
12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week
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.
1 month
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.
2 weeks
Number of participants with an asthma exacerbation event
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Isaretta Riley, MD-MPH, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

June 23, 2025

First Submitted That Met QC Criteria

June 23, 2025

First Posted (Actual)

July 1, 2025

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00114349

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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