Health TrialsbyHealthPanel

COPD Resources, Education, and Activity Designed for You Study

ConditionCOPD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorRush University Medical Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Factorial

Treatments tested in this trial

  • 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.

Treatment groups

448 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Condition #1Experimental treatment 3 interventions
Group B: Condition #2Experimental treatment 2 interventions
Group C: Condition #3Experimental treatment 2 interventions
Group D: Condition #4Experimental treatment 1 intervention
Group E: Condition #5Experimental treatment 3 interventions
Group F: Condition #6Experimental treatment 2 interventions
Group G: Condition #7Experimental treatment 2 interventions
Group H: Condition #8Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

12-month respiratory-related hospitalization

Incidence of one or more respiratory-related hospitalization at 12-month follow-up

Time frame
12 months

Secondary outcomes

1

Health-related quality of life

Change in Chronic Respiratory Disease Questionnaire (CRQ)-Mastery subscale score from baseline to 12-week follow-up. A mean score will be computed for the CRQ-Mastery subscale (range 1-7), with higher scores indicating a better outcome.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rush University Medical Center

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

University of Chicago

Collaborator

American Lung Association

Collaborator

Source ClinicalTrials.gov
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