COPD Resources, Education, and Activity Designed for You Study

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Rush University Medical Center
Study ID
NCT07125053
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Education (self-guided) — BEHAVIORAL
    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) — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Aug 18, 2025
Status verified
Sep 2025
Primary completion
Sep 1, 2029
Completion
Sep 1, 2029

Study Design

Enrollment
448 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60612
Maritza Esqueda Medina, B.A.
[email protected]
312-563-3702
Amanda R. Mathew, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By condition
COPD
By specialty
PulmonologyLung disease
By research site
Rush University Medical Center· Chicago, IL

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