Coping With Asthma Throughout Life Management Program

NCT07044388 | Not Yet Recruiting

• 1 other identifier: Pro00114349
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma; Stress

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  12 Weeks

Secondary Outcomes (4)

• Asthma Control Questionnaire (ACQ-6)

  1 week

• Perceived Stress Scale (PSS-10)

  1 month

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

  2 weeks

• Number of participants with an asthma exacerbation event

  12 weeks

Study Arms (2)

Randomized

EXPERIMENTAL

Group will receive intervention method

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.

Behavioral: Waitlist Control (CALM)

Interventions

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.

Waitlist Control Group

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.

Randomized

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Conditions

Asthma

Interventions

Coping Skills

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Isaretta Riley, MD-MPH

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isaretta Riley, MD-MPH

CONTACT

919-613-7682; isaretta.riley@duke.edu

TraNae Gibbs, BS

CONTACT

919-479-0861; tranae.gibbs@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 1, 2025
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 20, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share