COPDPhase 3NCT04517500
A Home-based Module to Promote Mindful Breathing Awareness for COPD Patients
A Phase 3 study testing Home-based pulmonary rehabilitation program, Mindful breathing module and Health coaching in people with COPD, run by Mayo Clinic at 2 sites in United States.
Trial summary
The purpose of this study is to develop a mindful breathing module to an already effective and developed home based rehabilitation program for guiding COPD patients in a mindful breathing practice and further palliate breathlessness and anxiety. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Home-based pulmonary rehabilitation program, Mindful breathing module and Health coaching
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Aug 2021to 7 May 2024
- Phase
- Phase 3
- 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
- Adults, age ≥ 40 years old.
- Clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD).
- At least 10 pack years of smoking.
Who cannot join
- Unable to do mild exercise (orthopedic-neurologic problems or confined to a bed).
- Unable to follow commands (cognitive impairment).
- Have a high likelihood of being lost to follow-up (active alcohol or drug abuse).
- Live in an area that does not have cellular service (Verizon).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Minnesota HealthSolutions Corporporation
Minneapolis, Minnesota, 55414
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients
The purpose of this study is to develop a mindful breathing module to an already effective and developed home based rehabilitation program for guiding COPD patients in a mindful breathing practice and further palliate breathlessness and anxiety.
Read the detailed description
A breathing technique called Pursed Lipped Breathing (PLB) has been proven to be beneficial for patients with COPD. PLB can ease shortness of breath and reduce stress and anxiety. This study will develop a mindful PLB module to compliment an already developed home based pulmonary rehabilitation program. In this study, patients will be randomized to either a group that does the home based pulmonary rehabilitation with the mindful breathing module and health coaching or a group that does the home based pulmonary rehabilitation with health coaching without the mindful breathing module. Both groups will do the home based pulmonary rehabilitation for 12 weeks. In addition there are questionnaires and the wearing of an activity monitor when you sign up and at 3 and 6 months.
- Conditions
- COPD
- Being tested
- Home-based pulmonary rehabilitation program, Mindful breathing module, Health coaching
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based pulmonary rehabilitation programBehavioural
Subjects will wear an activity monitor while doing at home exercises using a computer tablet
Mindful breathing moduleBehavioural
Additional module on the computer tablet that involves inhaling and exhaling while following an animated ball on the computer screen.
Health coachingBehavioural
Weekly coaching calls to discuss rehabilitation and health process using motivational interviewing
| Study group | Role | What they receive |
|---|---|---|
| Home-base pulmonary rehabilitation with mindful breathing modu | Experimental | Subjects will complete in a home-based pulmonary rehabilitation program and in addition will complete a mindful breathing practice using a module on a computer tablet. Receives: Behavioral: Home-based pulmonary rehabilitation program; Behavioral: Mindful breathing module; Behavioral: Health coaching |
| Home-base pulmonary rehabilitation | Active comparator | Subjects will complete 12 week home-based pulmonary rehabilitation with health coaching Receives: Behavioral: Home-based pulmonary rehabilitation program; Behavioral: Health coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Chronic Respiratory Disease Questionnaire (CRQ)- Dyspnea Score
The CRQ-Dyspnea is a 5-item questionnaire that assesses dyspnea on a Likert scale from 1 (Extremely short of breath) to 7 (Not at all short of breath). Total scores range from 5 - 35. Lower scores indicated higher severity of dyspnea. Higher scores indicate less severity of dyspnea.
Measured: Baseline, 3 months, 6 months
Change in Chronic Respiratory Disease Questionnaire (CRQ)- Emotions Score
The CRQ-Emotions is a 7-item questionnaire that assesses emotions on a Likert scale from 1 (All of the time) to 7 (None of the time). Total scores range from 7-49. Lower scores indicate more severity of emotions. Higher scores indicate less severity of emotions.
Measured: baseline, 3 months, 6 months
Secondary outcomes (1)
Change in Daily Physical Activity
Mean change in the number of steps per day
Measured: baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start6 Aug 2021
- Primary completion7 May 2024
- Study completion7 May 2024
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 Mayo ClinicThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Half of the participants will be randomized to receive the home-based PR with the mindful breathing module which consists of the Pursed Lipped Breathing Application and the Spire Health Tags (intervention) and half will receive the home-based PR (control).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Minnesota HealthSolutions
- Responsible party
- Principal investigator, Roberto P. Benzo, Mayo Clinic
- Investigators
- Roberto P Benzo, Principal investigator, Mayo ClinicKevin Kramer, PhD, Principal investigator, Minnesota HealthSolutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04517500
- Sponsor's protocol ID
- 19-012772
- Other IDs
- 2R44AT009665-02
- Status last verified
- Nov 2024
- First submitted
- 17 Jul 2020
- Last updated
- 8 Nov 2024
- 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 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients
- ClinicalTrials.gov ID
- NCT04517500
- Acronym / sponsor ID
- 19-012772
- Conditions
- COPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Minnesota HealthSolutions
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- 7 May 2024 (actual)
- Study completion
- 7 May 2024 (actual)
- First posted
- 18 Aug 2020 (actual)
- Results
- Posted 8 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop a mindful breathing module to an already effective and developed home based rehabilitation program for guiding COPD patients in a mindful breathing practice and further palliate breathlessness and anxiety.
Detailed description
A breathing technique called Pursed Lipped Breathing (PLB) has been proven to be beneficial for patients with COPD. PLB can ease shortness of breath and reduce stress and anxiety. This study will develop a mindful PLB module to compliment an already developed home based pulmonary rehabilitation program. In this study, patients will be randomized to either a group that does the home based pulmonary rehabilitation with the mindful breathing module and health coaching or a group that does the home based pulmonary rehabilitation with health coaching without the mindful breathing module. Both groups will do the home based pulmonary rehabilitation for 12 weeks. In addition there are questionnaires and the wearing of an activity monitor when you sign up and at 3 and 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Half of the participants will be randomized to receive the home-based PR with the mindful breathing module which consists of the Pursed Lipped Breathing Application and the Spire Health Tags (intervention) and half will receive the home-based PR (control).
| Arm | Type | Receives |
|---|---|---|
| Home-base pulmonary rehabilitation with mindful breathing modu | Experimental | Behavioral: Home-based pulmonary rehabilitation program, Behavioral: Mindful breathing module, Behavioral: Health coachingSubjects will complete in a home-based pulmonary rehabilitation program and in addition will complete a mindful breathing practice using a module on a computer tablet. |
| Home-base pulmonary rehabilitation | Active comparator | Behavioral: Home-based pulmonary rehabilitation program, Behavioral: Health coachingSubjects will complete 12 week home-based pulmonary rehabilitation with health coaching |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults, age ≥ 40 years old.
- Clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD).
- At least 10 pack years of smoking.
Key exclusion criteria (4 listed)
- Unable to do mild exercise (orthopedic-neurologic problems or confined to a bed).
- Unable to follow commands (cognitive impairment).
- Have a high likelihood of being lost to follow-up (active alcohol or drug abuse).
- Live in an area that does not have cellular service (Verizon).
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 |
|---|---|---|
| Home-based pulmonary rehabilitation programSubjects will wear an activity monitor while doing at home exercises using a computer tablet | Behavioural | Home-base pulmonary rehabilitation, Home-base pulmonary rehabilitation with mindful breathing modu |
| Mindful breathing moduleAdditional module on the computer tablet that involves inhaling and exhaling while following an animated ball on the computer screen. | Behavioural | Home-base pulmonary rehabilitation with mindful breathing modu |
| Health coachingWeekly coaching calls to discuss rehabilitation and health process using motivational interviewing | Behavioural | Home-base pulmonary rehabilitation, Home-base pulmonary rehabilitation with mindful breathing modu |
Primary outcome
Change in Chronic Respiratory Disease Questionnaire (CRQ)- Dyspnea Score
Time frame: Baseline, 3 months, 6 months
The CRQ-Dyspnea is a 5-item questionnaire that assesses dyspnea on a Likert scale from 1 (Extremely short of breath) to 7 (Not at all short of breath). Total scores range from 5 - 35. Lower scores indicated higher severity of dyspnea. Higher scores indicate less severity of dyspnea.
Change in Chronic Respiratory Disease Questionnaire (CRQ)- Emotions Score
Time frame: baseline, 3 months, 6 months
The CRQ-Emotions is a 7-item questionnaire that assesses emotions on a Likert scale from 1 (All of the time) to 7 (None of the time). Total scores range from 7-49. Lower scores indicate more severity of emotions. Higher scores indicate less severity of emotions.
1 secondary outcome
Change in Daily Physical Activity
Time frame: baseline, 3 months, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- 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.
Roberto P Benzo principal investigator
Mayo Clinic
Kevin Kramer, PhD principal investigator
Minnesota HealthSolutions
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Home-based pulmonary rehabilitation program, Mindful breathing module and Health coaching in people with COPD, run by Mayo Clinic at 2 sites 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 3 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 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2024). 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?
Change in Chronic Respiratory Disease Questionnaire (CRQ)- Dyspnea Score (time frame: Baseline, 3 months, 6 months). The study lists 2 primary outcomes in all. 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 8 Nov 2024.