Optimizing Self-management COPD Treatment Through the American Lung Association Helpline

Not Applicable

Completed

• Conditions: Copd

• Registration Number: NCT05106257
• Lead Sponsor: Rush University Medical Center

Brief Summary

Although self-management treatment improves quality of life among individuals with COPD, there is limited understanding of which elements of treatment are most effective. The proposed research will test the feasibility of using an engineering-inspired study design to identify effective COPD self-management treatment components. The long-term goal of this line of research is to optimize the effectiveness of COPD self-management treatment, and improve quality of life for individuals with COPD.

Detailed Description

Chronic Obstructive Pulmonary Disease (COPD) is an increasingly prevalent and costly chronic health condition, and is the third major cause of morbidity and mortality in the United States. Self-management treatment programs for COPD are shown to improve health-related quality of life and prevent COPD-related hospitalizations. Despite their clinical benefits, these programs are typically multi-component and time- and resource-intensive. To date, no study has been conducted to isolate the role of individual self-management treatment components in contributing to improved COPD outcomes. The proposed research will establish the feasibility of using the Multiphase Optimization Strategy (MOST) framework to optimize COPD self-management treatment delivered by the American Lung Association (ALA) Helpline. Treatment components to be evaluated include duration of self-management education, ground-based walking training, inhaler training, and caregiver support. The primary outcome is health-related quality of life, with secondary outcomes of COPD symptom burden, self-management behaviors, and hospitalization. Specific aims are:

Aim 1: Design a factorial experiment and develop operational procedures. The investigators will design a factorial experiment with the same number of experimental conditions and length of follow-up as the planned optimization trial. In collaboration with the ALA COPD Helpline, the investigators will develop operational procedures (i.e., recruitment, screening, randomization, and database management) for successful implementation.

Aim 2: Establish feasibility and acceptability by pilot testing the study design. The investigators will deliver treatment to three participants per experimental condition (N=48) with good fidelity, and will remotely assess baseline, mediator, and outcome variables. The investigators will conduct qualitative interviews at end-of-treatment with 15-20 participants. Resulting values will provide estimates of recruitment and retention rates, treatment fidelity, acceptability of treatment components, and outcome measure variability to inform a subsequent, fully-powered optimization trial. The primary outcome is health-related quality of life, with secondary outcomes of COPD symptom burden, self-management behaviors, and hospitalization.

Study Timeline

• Study First Submitted: 2021-10-12
• Study First Submitted QC: 2021-10-21
• Study First Posted: 2021-11-03
• Study Start: 2021-11-05
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Results First Submitted: 2024-07-26
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-31
• Last Update Submitted: 2025-01-31
• Results First Posted: 2025-02-20
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Health-related Quality of Life	Change from baseline at 90-day follow-up	Measured by the Chronic Respiratory Disease Questionnaire (CRQ) dyspnea subscale score. Possible scale range is 1-7; higher scores indicate better health-related quality of life.

Secondary Outcome Measures

Name	Time	Method
Hospitalization	Incidence at 90-day follow-up	Self-reported hospitalization history.
COPD Symptom Burden	Change from baseline at 90-day follow-up	Measured by the COPD Assessment Test (CAT), an 8-item questionnaire measuring the global impact of dyspnea on health status. Possible score range is 0-40; higher scores indicate more severe symptom impact.
Self-management Behaviors	Change from baseline at 90-day follow-up	Measured by the Patient Activation Measure (PAM-13), a 13-item questionnaire measuring patient knowledge, skill, and confidence for self-management. Items are summed to yield a raw score (possible range 13-52), which is then converted to a normalized score (possible range 0-100). Higher scores indicate better self-management.

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States