RecruitingNot ApplicableNCT07125053

COPD Resources, Education, and Activity Designed for You Study

Optimizing Effectiveness and Implementation of COPD Self-Management Treatment


Sponsor

Rush University Medical Center

Enrollment

448 participants

Start Date

Aug 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 40 Years

Inclusion Criteria6

  • 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 Criteria7

  • 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

Interventions

BEHAVIORALEducation (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.

BEHAVIORALEducation (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, recognizing COPD exacerbations, and coping with breathlessness.

BEHAVIORALPhysical 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) over the course of 6 weeks in the main treatment phase, with two additional optional booster sessions between week 6 and 12.

BEHAVIORALInhaler 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.


Locations(1)

Rush University Medical Center

Chicago, Illinois, United States

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NCT07125053


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