COPD Resources, Education, and Activity Designed for You Study

Official title

Optimizing Effectiveness and Implementation of COPD Self-Management Treatment

Overview

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.

Detailed 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.

Interventions

• Behavioral Education (self-guided)
  The self-guided eduction program consists of a mailed booklet entitled, "Learning to live with COPD," along with two additional mailings with information on the ALA's Patient and Caregiver Network and the Respiratory Health Association's COPD Caregiver's Toolkit.
• Behavioral Education (counselor-led)
  The counselor-led education program combines mailings with phone counseling delivered by ALA Lung Helpline counselors. Three phone sessions (20-30 minutes each) are completed over the course of 6 weeks in the main treatment phase, with two additional optional booster sessions offered between 6 and 12-weeks post-randomization. The counselor-led program follows a structured outline of curriculum for each session, focusing on the topic areas of developing a COPD exacerbation action plan, recognizin
• Behavioral Physical Activity
  The physical activity program will consist of a personalized prescription for home-based exercise following published guidelines, consisting of aerobic, strengthening, and flexibility exercises, tailored to participants' current fitness level and dyspnea symptoms. Aerobic exercise will incorporate ground-based walking training, a well-established, safe, and feasible physical activity program for individuals with COPD. Participants will complete three videoconference sessions (30-45 minutes each)
• Behavioral Inhaler Training
  Participants will receive inhaler technique education using a virtual teach-to-goal method. In each session, individuals are observed using their inhaler, provided feedback, and then observed again. Inhaler technique is scored using a checklist specific to each inhaler device. Participants will complete two inhaler training sessions via videoconference at week 1 and week 4, with an optional booster session offered at week 8.

Primary outcome measures

• 12-month respiratory-related hospitalization [Time frame: 12 months]

Secondary outcome measures (1)

• Health-related quality of life [Time frame: 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Factorial

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Rush University Medical Center — Chicago

Identifiers

NCT: NCT07125053 · ORA# 23050802 · R01HL173120-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗