Optimizing Self-management COPD Treatment Through the American Lung Association Helpline
1 other identifier
interventional
46
1 country
1
Brief Summary
Although self-management treatment improves quality of life among individuals with COPD, there is limited understanding of which elements of treatment are most effective. The proposed research will test the feasibility of using an engineering-inspired study design to identify effective COPD self-management treatment components. The long-term goal of this line of research is to optimize the effectiveness of COPD self-management treatment, and improve quality of life for individuals with COPD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2021
CompletedFirst Posted
Study publicly available on registry
November 3, 2021
CompletedStudy Start
First participant enrolled
November 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedResults Posted
Study results publicly available
February 20, 2025
CompletedFebruary 20, 2025
January 1, 2025
1.6 years
October 12, 2021
July 26, 2024
January 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Health-related Quality of Life
Measured by the Chronic Respiratory Disease Questionnaire (CRQ) dyspnea subscale score. Possible scale range is 1-7; higher scores indicate better health-related quality of life.
Change from baseline at 90-day follow-up
Secondary Outcomes (3)
COPD Symptom Burden
Change from baseline at 90-day follow-up
Self-management Behaviors
Change from baseline at 90-day follow-up
Hospitalization
Incidence at 90-day follow-up
Study Arms (16)
Condition #1
EXPERIMENTALEducation = short Walking training = on Inhaler training = on Caregiver support = on
Condition #2
EXPERIMENTALEducation = short Walking training = on Inhaler training = on Caregiver support = off
Condition #3
EXPERIMENTALEducation = short Walking training = on Inhaler training = off Caregiver support = on
Condition #4
EXPERIMENTALEducation = short Walking training = on Inhaler training = off Caregiver support = off
Condition #5
EXPERIMENTALEducation = short Walking training = off Inhaler training = on Caregiver support = on
Condition #6
EXPERIMENTALEducation = short Walking training = off Inhaler training = on Caregiver support = off
Condition #7
EXPERIMENTALEducation = short Walking training = off Inhaler training = off Caregiver support = on
Condition #8
EXPERIMENTALEducation = short Walking training = off Inhaler training = off Caregiver support = off
Condition #9
EXPERIMENTALEducation = long Walking training = on Inhaler training = on Caregiver support = on
Condition #10
EXPERIMENTALEducation = long Walking training = on Inhaler training = on Caregiver support = off
Condition #11
EXPERIMENTALEducation = long Walking training = on Inhaler training = off Caregiver support = on
Condition #12
EXPERIMENTALEducation = long Walking training = on Inhaler training = off Caregiver support = off
Condition #13
EXPERIMENTALEducation = long Walking training = off Inhaler training = on Caregiver support = on
Condition #14
EXPERIMENTALEducation = long Walking training = off Inhaler training = on Caregiver support = off
Condition #15
EXPERIMENTALEducation = long Walking training = off Inhaler training = off Caregiver support = on
Condition #16
EXPERIMENTALEducation = long Walking training = off Inhaler training = off Caregiver support = off
Interventions
The self-management education condition is based on the Living Well with COPD program. The program consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. Topics include disease information, breathing retraining, action planning, medication use, energy conservation, and following good health habits. The short condition consists of two calls (30-45 minutes each) to introduce patient education topics and refer to the booklet for further information.
Participants randomized to this condition will be mailed a pedometer (3DFitBud Simple Step Counter) and instructed on its use to establish baseline steps/ day for 7 days. They will then receive a booklet with instructions to establish a walking program and three brief (10-15 minute), bi-weekly calls from a trained staff member to review step count values and engage in setting personal activity goals over the course of 6 weeks, following established exercise guidelines for individuals with COPD.
Participants randomized to this condition will receive two sessions of inhaler technique education using a virtual teach-to-goal (TTG) method in which individuals are observed using their inhaler, provided feedback, and then observed again.
Participants randomized to this condition will identify an informal caregiver who is involved in their healthcare (i.e., spouse, family member, or friend), who will receive a mailed copy of the Respiratory Health Association's COPD Caregiver's Toolkit, a comprehensive informational resource to support the care of the person living with COPD. Caregivers will receive two brief (10-15 minute) check-in calls from a trained staff member. The structured content of these sessions will include providing an overview of toolkit content, identifying goals for sections(s) to review and incorporate into caregiving activities, and addressing any questions.
The self-management education condition is based on the Living Well with COPD program. The program consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. Topics include disease information, breathing retraining, action planning, medication use, energy conservation, and following good health habits. The long condition consists of five, weekly calls (30-45 minutes each) following a structured curriculum of patient education topics.
Eligibility Criteria
You may qualify if:
- Eligible participants will be males and females who are:
- years or older,
- report a physician diagnosis of COPD,
- use an inhaler for COPD at least once a week,
- able to walk at least one block without assistance,
- able to identify a caregiver, and
- have access to a connected device (i.e., smart phone, tablet, and/ or computer).
You may not qualify if:
- cognitive dysfunction impairing ability to provide informed consent and follow study procedures,
- terminal illness (i.e. less than 6 months life expectancy) that is non-COPD related,
- living at a chronic care facility (i.e. nursing home, assisted living), or
- inability to speak and read English.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rush University Medical Centerlead
- American Lung Associationcollaborator
Study Sites (1)
Rush University Medical Center
Chicago, Illinois, 60612, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Amanda R. Mathew, PhD
- Organization
- Rush University Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Amanda R Mathew, PhD
Rush University Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2021
First Posted
November 3, 2021
Study Start
November 5, 2021
Primary Completion
June 30, 2023
Study Completion
June 30, 2023
Last Updated
February 20, 2025
Results First Posted
February 20, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share