COPD Resources, Education, and Activity Designed for You Study (COPD READY)

Rush

Status: Enrolling

Conditions: COPD

Treatments: Behavioral: Physical Activity; Behavioral: Education (self-guided); Behavioral: Inhaler Training; Behavioral: Education (counselor-led)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07125053

ORA# 23050802

R01HL173120-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Although COPD self-management treatment programs are effective in reducing COPD-related hospitalizations and increasing quality of life, there is a limited understanding of 'how and why' they work. The proposed research will use an engineering-inspired study design to identify effective COPD self-management treatment components and guide its 'real world' implementation. The long-term goal of this line of research is to build an optimized COPD self-management program, and scale the program up to reduce the burden of COPD at a population health level.

Full description

The study's overall objective is to test component effects of COPD self-management treatment and select an optimized treatment program, while simultaneously gathering information on factors impacting implementation (i.e., Hybrid Type 1 Effectiveness-Implementation Study).1 The study design is guided by the Multiphase Optimization Strategy (MOST),2 an innovative, engineering-inspired methodological framework for intervention development that uses highly efficient randomized experimentation to assess the performance of treatment components on clinically-relevant outcomes, independently and in combination. The proposed research will achieve the following Specific Aims:

Aim 1. Determine the main and interactive effects of three treatment components (i.e., self-management education, inhaler training, and physical activity) on a) respiratory-related hospitalizations over 12 months (primary outcome), and b) health-related quality of life (secondary outcome) by conducting a 2x2x2 factorial experiment. Program costs associated with delivery of each treatment condition will be measured and mediation analyses will be conducted to further understand the mechanisms of component effects.

Sub-Aim 1a. Examine the interaction of baseline disease severity and comorbid conditions (i.e., cardiovascular disease, lung cancer, sleep apnea, metabolic syndrome) with each treatment component on outcomes, to explore potential differences in treatment response.

Aim 2. Select the optimized treatment program. The investigators will identify the optimized treatment package that produces the best expected outcomes (i.e., reduction in respiratory-related hospitalizations and increased health-related quality of life), while maintaining efficiency in the program cost for treatment delivery.

Aim 3. Develop a set of implementation strategies to increase referrals to the optimized treatment program by conducting a mixed methods process evaluation with healthcare providers (N=10-20) and administrators (N=10-20). Informed by the Consolidated Framework for Implementation Research (CFIR), the investigators will assess the barriers and facilitators impacting the program referral workflow, and use this data to inform selection of implementation strategies to increase referrals.

Enrollment: 448 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Residence in the continental United States
• Age 40 years or older
• Report a physician diagnosis of COPD
• Report a COPD-related hospitalization over the past 12 months
• Use an inhaled medication for COPD at least once per week
• Have access to a connected device (i.e., smartphone, tablet, and/ or computer) to complete study procedures

Exclusion criteria

• COPD exacerbation within the past month
• New or worsening chest pain that happens without exertion
• Cognitive dysfunction impairing ability to provide informed consent and follow study procedures
• Terminal illness (i.e., < 6 month life expectancy) that is non-COPD related
• Living at a chronic care facility (i.e., nursing home, assisted living)
• Inability to participate in mild physical activity such as walking, stretching, and lower limb exercises
• Inability to speak/ read English

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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448 participants in 8 patient groups

Condition #1

Experimental group

Description:

Education = self-guided; Physical Activity = on; Inhaler Training = on

Treatment:

Behavioral: Inhaler Training

Behavioral: Education (self-guided)

Behavioral: Physical Activity

Condition #2

Experimental group

Description:

Education = self-guided; Physical Activity = on; Inhaler Training = off

Treatment:

Behavioral: Education (self-guided)

Behavioral: Physical Activity

Condition #3

Experimental group

Description:

Education = self-guided; Physical Activity = off; Inhaler Training = on

Treatment:

Behavioral: Inhaler Training

Behavioral: Education (self-guided)

Condition #4

Experimental group

Description:

Education = self-guided; Physical Activity = off; Inhaler Training = off

Treatment:

Behavioral: Education (self-guided)

Condition #5

Experimental group

Description:

Education = counselor-led; Physical Activity = on; Inhaler Training = on

Treatment:

Behavioral: Education (counselor-led)

Behavioral: Inhaler Training

Behavioral: Physical Activity

Condition #6

Experimental group

Description:

Education = counselor-led; Physical Activity = on; Inhaler Training = off

Treatment:

Behavioral: Education (counselor-led)

Behavioral: Physical Activity

Condition #7

Experimental group

Description:

Education = counselor-led; Physical Activity = off; Inhaler Training = on

Treatment:

Behavioral: Education (counselor-led)

Behavioral: Inhaler Training

Condition #8

Experimental group

Description:

Education = counselor-led; Physical Activity = off; Inhaler Training = off

Treatment:

Behavioral: Education (counselor-led)