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Coping With Asthma Throughout Life Management Program

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

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07044388
Acronym
CALM
Enrollment
0
Registered
2025-07-01
Start date
2026-06-15
Completion date
2026-09-30
Last updated
2026-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Stress

Brief 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.

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.

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.

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of Intervention Measure (FIM)12 weeksThe 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)12 WeeksThe AIM has four items and the total score ranges from 4 to 20, where a higher score indicates greater acceptability.
Intervention Appropriateness Measure (IAM)12 WeeksThe IAM has four items and the total score ranges from 4 to 20, where a higher score indicates greater appropriateness.

Secondary

MeasureTime frameDescription
Asthma Control Questionnaire (ACQ-6)1 weekThe 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.
Perceived Stress Scale (PSS-10)1 monthThe 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.
Asthma Quality of Life Questionnaire, Marks (AQLQ-M)2 weeksThe 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.
Number of participants with an asthma exacerbation event12 weeks

Contacts

PRINCIPAL_INVESTIGATORIsaretta Riley, MD-MPH

Duke University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 8, 2026