CopdNCT05106257
Optimizing Self-management COPD Treatment Through the American Lung Association Helpline
A study testing Self-management education (short), Ground-based walking training and Inhaler training in people with Copd, run by Rush University Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Copd
- What is being tested?
- Self-management education (short), Ground-based walking training and Inhaler training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible participants will be males and females who are:
- 40 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
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.
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) is an increasingly prevalent and costly chronic health condition, and is the third major cause of morbidity and mortality in the United States. Self-management treatment programs for COPD are shown to improve health-related quality of life and prevent COPD-related hospitalizations. Despite their clinical benefits, these programs are typically multi-component and time- and resource-intensive. To date, no study has been conducted to isolate the role of individual self-management treatment components in contributing to improved COPD outcomes. The proposed research will establish the feasibility of using the Multiphase Optimization Strategy (MOST) framework to optimize COPD self-management treatment delivered by the American Lung Association (ALA) Helpline. Treatment components to be evaluated include duration of self-management education, ground-based walking training, inhaler training, and caregiver support. The primary outcome is health-related quality of life, with secondary outcomes of COPD symptom burden, self-management behaviors, and hospitalization. Specific aims are:
Aim 1: Design a factorial experiment and develop operational procedures. The investigators will design a factorial experiment with the same number of experimental conditions and length of follow-up as the planned optimization trial. In collaboration with the ALA COPD Helpline, the investigators will develop operational procedures (i.e., recruitment, screening, randomization, and database management) for successful implementation.
Aim 2: Establish feasibility and acceptability by pilot testing the study design. The investigators will deliver treatment to three participants per experimental condition (N=48) with good fidelity, and will remotely assess baseline, mediator, and outcome variables. The investigators will conduct qualitative interviews at end-of-treatment with 15-20 participants. Resulting values will provide estimates of recruitment and retention rates, treatment fidelity, acceptability of treatment components, and outcome measure variability to inform a subsequent, fully-powered optimization trial. The primary outcome is health-related quality of life, with secondary outcomes of COPD symptom burden, self-management behaviors, and hospitalization.
- Conditions
- Copd
- Being tested
- Self-management education (short), Ground-based walking training, Inhaler training, Caregiver support, Self-management education (long)
- Keywords
- COPD, Self-management, Lifestyle change, Patient education, Quality of life, Physical activity, Inhaler use, Caregiver support
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-management education (short)Behavioural
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.
Ground-based walking trainingBehavioural
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.
Inhaler trainingBehavioural
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.
Caregiver supportBehavioural
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.
Self-management education (long)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Condition #1 | Experimental | Education = short Walking training = on Inhaler training = on Caregiver support = on Receives: Behavioral: Self-management education (short); Behavioral: Ground-based walking training; Behavioral: Inhaler training; Behavioral: Caregiver support |
| Condition #2 | Experimental | Education = short Walking training = on Inhaler training = on Caregiver support = off Receives: Behavioral: Self-management education (short); Behavioral: Ground-based walking training; Behavioral: Inhaler training |
| Condition #3 | Experimental | Education = short Walking training = on Inhaler training = off Caregiver support = on Receives: Behavioral: Self-management education (short); Behavioral: Ground-based walking training; Behavioral: Caregiver support |
| Condition #4 | Experimental | Education = short Walking training = on Inhaler training = off Caregiver support = off Receives: Behavioral: Self-management education (short); Behavioral: Ground-based walking training |
| Condition #5 | Experimental | Education = short Walking training = off Inhaler training = on Caregiver support = on Receives: Behavioral: Self-management education (short); Behavioral: Inhaler training; Behavioral: Caregiver support |
| Condition #6 | Experimental | Education = short Walking training = off Inhaler training = on Caregiver support = off Receives: Behavioral: Self-management education (short); Behavioral: Inhaler training |
| Condition #7 | Experimental | Education = short Walking training = off Inhaler training = off Caregiver support = on Receives: Behavioral: Self-management education (short); Behavioral: Caregiver support |
| Condition #8 | Experimental | Education = short Walking training = off Inhaler training = off Caregiver support = off Receives: Behavioral: Self-management education (short) |
| Condition #9 | Experimental | Education = long Walking training = on Inhaler training = on Caregiver support = on Receives: Behavioral: Ground-based walking training; Behavioral: Inhaler training; Behavioral: Caregiver support; Behavioral: Self-management education (long) |
| Condition #10 | Experimental | Education = long Walking training = on Inhaler training = on Caregiver support = off Receives: Behavioral: Ground-based walking training; Behavioral: Inhaler training; Behavioral: Self-management education (long) |
| Condition #11 | Experimental | Education = long Walking training = on Inhaler training = off Caregiver support = on Receives: Behavioral: Ground-based walking training; Behavioral: Caregiver support; Behavioral: Self-management education (long) |
| Condition #12 | Experimental | Education = long Walking training = on Inhaler training = off Caregiver support = off Receives: Behavioral: Ground-based walking training; Behavioral: Self-management education (long) |
| Condition #13 | Experimental | Education = long Walking training = off Inhaler training = on Caregiver support = on Receives: Behavioral: Inhaler training; Behavioral: Caregiver support; Behavioral: Self-management education (long) |
| Condition #14 | Experimental | Education = long Walking training = off Inhaler training = on Caregiver support = off Receives: Behavioral: Inhaler training; Behavioral: Self-management education (long) |
| Condition #15 | Experimental | Education = long Walking training = off Inhaler training = off Caregiver support = on Receives: Behavioral: Caregiver support; Behavioral: Self-management education (long) |
| Condition #16 | Experimental | Education = long Walking training = off Inhaler training = off Caregiver support = off Receives: Behavioral: Self-management education (long) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline at 90-day follow-up
Secondary outcomes (3)
COPD Symptom Burden
Measured by the COPD Assessment Test (CAT), an 8-item questionnaire measuring the global impact of dyspnea on health status. Possible score range is 0-40; higher scores indicate more severe symptom impact.
Measured: Change from baseline at 90-day follow-up
Self-management Behaviors
Measured by the Patient Activation Measure (PAM-13), a 13-item questionnaire measuring patient knowledge, skill, and confidence for self-management. Items are summed to yield a raw score (possible range 13-52), which is then converted to a normalized score (possible range 0-100). Higher scores indicate better self-management.
Measured: Change from baseline at 90-day follow-up
Hospitalization
Self-reported hospitalization history.
Measured: Incidence at 90-day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start5 Nov 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CopdStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Lung Association
- Responsible party
- Sponsor
- Investigators
- Amanda R Mathew, PhD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106257
- Sponsor's protocol ID
- 20050506
- Status last verified
- Jan 2025
- First submitted
- 12 Oct 2021
- Last updated
- 20 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Self-management COPD Treatment Through the American Lung Association Helpline
- ClinicalTrials.gov ID
- NCT05106257
- Acronym / sponsor ID
- 20050506
- Conditions
- Copd
- Keywords
- COPD, Self-management, Lifestyle change, Patient education, Quality of life, Physical activity, Inhaler use, Caregiver support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- American Lung Association
- Study start
- 5 Nov 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 3 Nov 2021 (actual)
- Results
- Posted 20 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is an increasingly prevalent and costly chronic health condition, and is the third major cause of morbidity and mortality in the United States. Self-management treatment programs for COPD are shown to improve health-related quality of life and prevent COPD-related hospitalizations. Despite their clinical benefits, these programs are typically multi-component and time- and resource-intensive. To date, no study has been conducted to isolate the role of individual self-management treatment components in contributing to improved COPD outcomes. The proposed research will establish the feasibility of using the Multiphase Optimization Strategy (MOST) framework to optimize COPD self-management treatment delivered by the American Lung Association (ALA) Helpline. Treatment components to be evaluated include duration of self-management education, ground-based walking training, inhaler training, and caregiver support. The primary outcome is health-related quality of life, with secondary outcomes of COPD symptom burden, self-management behaviors, and hospitalization. Specific aims are:
Aim 1: Design a factorial experiment and develop operational procedures. The investigators will design a factorial experiment with the same number of experimental conditions and length of follow-up as the planned optimization trial. In collaboration with the ALA COPD Helpline, the investigators will develop operational procedures (i.e., recruitment, screening, randomization, and database management) for successful implementation.
Aim 2: Establish feasibility and acceptability by pilot testing the study design. The investigators will deliver treatment to three participants per experimental condition (N=48) with good fidelity, and will remotely assess baseline, mediator, and outcome variables. The investigators will conduct qualitative interviews at end-of-treatment with 15-20 participants. Resulting values will provide estimates of recruitment and retention rates, treatment fidelity, acceptability of treatment components, and outcome measure variability to inform a subsequent, fully-powered optimization trial. The primary outcome is health-related quality of life, with secondary outcomes of COPD symptom burden, self-management behaviors, and hospitalization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Condition #1 | Experimental | Behavioral: Self-management education (short), Behavioral: Ground-based walking training, Behavioral: Inhaler training, Behavioral: Caregiver supportEducation = short Walking training = on Inhaler training = on Caregiver support = on |
| Condition #2 | Experimental | Behavioral: Self-management education (short), Behavioral: Ground-based walking training, Behavioral: Inhaler trainingEducation = short Walking training = on Inhaler training = on Caregiver support = off |
| Condition #3 | Experimental | Behavioral: Self-management education (short), Behavioral: Ground-based walking training, Behavioral: Caregiver supportEducation = short Walking training = on Inhaler training = off Caregiver support = on |
| Condition #4 | Experimental | Behavioral: Self-management education (short), Behavioral: Ground-based walking trainingEducation = short Walking training = on Inhaler training = off Caregiver support = off |
| Condition #5 | Experimental | Behavioral: Self-management education (short), Behavioral: Inhaler training, Behavioral: Caregiver supportEducation = short Walking training = off Inhaler training = on Caregiver support = on |
| Condition #6 | Experimental | Behavioral: Self-management education (short), Behavioral: Inhaler trainingEducation = short Walking training = off Inhaler training = on Caregiver support = off |
| Condition #7 | Experimental | Behavioral: Self-management education (short), Behavioral: Caregiver supportEducation = short Walking training = off Inhaler training = off Caregiver support = on |
| Condition #8 | Experimental | Behavioral: Self-management education (short)Education = short Walking training = off Inhaler training = off Caregiver support = off |
| Condition #9 | Experimental | Behavioral: Ground-based walking training, Behavioral: Inhaler training, Behavioral: Caregiver support, Behavioral: Self-management education (long)Education = long Walking training = on Inhaler training = on Caregiver support = on |
| Condition #10 | Experimental | Behavioral: Ground-based walking training, Behavioral: Inhaler training, Behavioral: Self-management education (long)Education = long Walking training = on Inhaler training = on Caregiver support = off |
| Condition #11 | Experimental | Behavioral: Ground-based walking training, Behavioral: Caregiver support, Behavioral: Self-management education (long)Education = long Walking training = on Inhaler training = off Caregiver support = on |
| Condition #12 | Experimental | Behavioral: Ground-based walking training, Behavioral: Self-management education (long)Education = long Walking training = on Inhaler training = off Caregiver support = off |
| Condition #13 | Experimental | Behavioral: Inhaler training, Behavioral: Caregiver support, Behavioral: Self-management education (long)Education = long Walking training = off Inhaler training = on Caregiver support = on |
| Condition #14 | Experimental | Behavioral: Inhaler training, Behavioral: Self-management education (long)Education = long Walking training = off Inhaler training = on Caregiver support = off |
| Condition #15 | Experimental | Behavioral: Caregiver support, Behavioral: Self-management education (long)Education = long Walking training = off Inhaler training = off Caregiver support = on |
| Condition #16 | Experimental | Behavioral: Self-management education (long)Education = long Walking training = off Inhaler training = off Caregiver support = off |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 40 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-management education (short)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. | Behavioural | Condition #1, Condition #2, Condition #3, Condition #4, Condition #5, Condition #6, Condition #7, Condition #8 |
| Ground-based walking trainingParticipants 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. | Behavioural | Condition #1, Condition #10, Condition #11, Condition #12, Condition #2, Condition #3, Condition #4, Condition #9 |
| Inhaler trainingParticipants 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. | Behavioural | Condition #1, Condition #10, Condition #13, Condition #14, Condition #2, Condition #5, Condition #6, Condition #9 |
| Caregiver supportParticipants 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. | Behavioural | Condition #1, Condition #11, Condition #13, Condition #15, Condition #3, Condition #5, Condition #7, Condition #9 |
| Self-management education (long)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. | Behavioural | Condition #10, Condition #11, Condition #12, Condition #13, Condition #14, Condition #15, Condition #16, Condition #9 |
Primary outcome
Health-related Quality of Life
Time frame: Change from baseline at 90-day follow-up
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.
3 secondary outcomes
COPD Symptom Burden
Time frame: Change from baseline at 90-day follow-up
Self-management Behaviors
Time frame: Change from baseline at 90-day follow-up
Hospitalization
Time frame: Incidence at 90-day follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda R Mathew, PhD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-management education (short), Ground-based walking training and Inhaler training in people with Copd, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related Quality of Life (time frame: Change from baseline at 90-day follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.