Recruiting

COPD Self-Management

Sponsor:

Rush University Medical Center

Code:

NCT07125053

Conditions

COPD

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Education (self-guided)

Education (counselor-led)

Physical Activity

Inhaler Training

Study Details

Brief 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.

Conditions

COPD

Study ID

NCT07125053

Start date

Aug 18, 2025

Status verified date

Sep, 2025

Completion date

Sep 1, 2029

Anticipated

Primary completion date

Sep 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

448 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Condition #1

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

experimental: Condition #2

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

experimental: Condition #3

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

experimental: Condition #4

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

experimental: Condition #5

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

experimental: Condition #6

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

experimental: Condition #7

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

experimental: Condition #8

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

Interventions

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.

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, recognizing COPD exacerbations, and coping with breathlessness.

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

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 measure

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

Central Contacts and Locations

Central contacts

Maritza Esqueda Medina, B.A.

3125633702COPD_READY@rush.edu

Amanda R. Mathew, PhD

3125631273COPD_READY@rush.edu

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Maritza Esqueda Medina, B.A.

312-563-3702COPD_READY@rush.edu

Principal Investigator:

Amanda R. Mathew, PhD

More Information

Sponsor

Rush University Medical Center

Last update posted

Sep 22, 2025

Last verified

Sep, 2025

Keywords

  • copd
  • emphysema
  • chronic bronchitis
  • self-management
  • lifestyle management
  • physical activity
  • inhaler use
  • patient education

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2025-09-22.