COPDMELODYNCT03653104
Melodica Orchestra for Dyspnea: Safety and Feasibility Pilot
A study testing Melodica Intervention and Pulmonary Health Education in people with COPD and Chronic Obstructive Pulmonary Disease, run by VA Quality Enhancement Research Intiative at 1 site in United States.
Trial summary
This project seeks to pilot-test the feasibility of using a melodica training program to teach pursed lip breathing for Veterans with chronic obstructive pulmonary disease (COPD) with moderate to severe dyspnea (shortness of breath). Dyspnea occurs commonly among COPD patients and can limit activities of daily living. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Chronic Obstructive Pulmonary Disease, Dyspnea
- What is being tested?
- Melodica Intervention and Pulmonary Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- spirometry-confirmed COPD defined as a FEV1/FVC <0.7
- moderate or severe dyspnea defined as a grade ≥3 on the ATS Dyspnea scale
Who cannot join
- visual or hearing impairments
- do not speak English
- do not have an intact airway
- have cognitive impairment
- are unable to make a seal with their mouths
- have a history of at least one hospital admission for congestive heart failure in the prior year
- receiving Hospital-Based Home Care (HBHC) or Telehealth care for COPD management
Trial locations and contacts
1 site in 1 country.
United States1 site
Veteran Health Indiana, Richard L. Roudebush VA Medical Center
Indianapolis, Indiana, 46202
About this study
This project seeks to pilot-test the feasibility of using a melodica training program to teach pursed lip breathing for Veterans with chronic obstructive pulmonary disease (COPD) with moderate to severe dyspnea (shortness of breath). Dyspnea occurs commonly among COPD patients and can limit activities of daily living. Pursed lip breathing is a strategy that can improve dyspnea and exercise capacity among COPD patients. The melodica is a musical instrument that looks like a keyboard with a mouthpiece on the side. The melodica is played by exhaling through the mouthpiece while pressing the keys. The MELODY pilot project protocol has been grounded on concepts from occupational therapy; specifically, providing participants with a meaningful new activity that is enjoyable, that can be provided across a spectrum of skill levels, that can provide participants with a new sense of self, and that can improve health outcomes (i.e., dyspnea and exercise endurance).
Read the detailed description
SPECIFIC AIMS:
Primary Aim 1: Evaluate the safety of a melodica training program to teach pursed lip breathing among Veterans with COPD with moderate to severe dyspnea. We hypothesize that a melodica training program can be safely implemented among COPD patients with severe dyspnea.
Primary Aim 2: Evaluate the feasibility of implementing a melodica training program to teach pursed lip breathing among Veterans with COPD with dyspnea. We hypothesize that it will be feasible to implement a melodica training program to teach pursed lip breathing among Veterans with COPD and dyspnea; specifically that enrolled participants will attend >50% of sessions. We also hypothesize that transportation to the VA Medical Center to attend sessions will be identified as a significant barrier to participation.
Secondary Aim: Collect pilot-efficacy data of a melodica training program to teach pursed lip breathing among Veterans with COPD and dyspnea. The objective is to understand whether melodica training improves dyspnea both in the short-term and in the longer-term over the course of the 8-week training program. We hypothesize that a melodica training program will reduce dyspnea by 30% in the short-term and 10% in the long-term. We also hypothesize that intervention participants will show gains in the secondary efficacy outcome measures of exercise endurance, pulmonary function, entering pulmonary rehabilitation, quality of life, patient global impression of change, and anxiety relative to controls.
RANDOMIZATION AND INTERVENTION:
Randomization:
Participants will be randomized in a 1:1:1 ratio to the intervention group (N=50), usual care control group (N=50), and education control group (N=50) using a block randomization design. We will also seek to identify N=30 Veterans who met the COPD diagnosis and spirometry eligibility criteria but who chose not to participate in the intervention; these Veterans will be invited to participate in a brief interview to identify barriers to participation.
Melodica Program Intervention:
The intervention program will include: education about pursed lip breathing, instruction in the melodica instrument, and participation in a melodica playing group which will meet twice-weekly for a 8-week period. Participants will be given instructional materials for use in practicing the instrument in their homes and encouragement to use pursed lip breathing not only while playing the instrument but also in their activities of daily living. Each session will last one hour in duration with approximately 20 minutes for instruction, 30 minutes in group music-making, and 10 minutes allocated for educational information about COPD, tobacco cessation, and pulmonary rehabilitation.
Education Group:
The patients in the education control group will receive the same educational materials that are provided to the intervention group; however, they will receive them in a single educational session. As described above, the educational materials include information about pursed lip breathing, COPD, medications used to treat COPD, how to use an inhaler, smoking cessation, pulmonary rehabilitation, oxygen therapy, exercise, and travelling with COPD. The materials include handouts as well as links to web pages.
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease, Dyspnea, Breathlessness, Emphysema, Chronic Bronchitis
- Being tested
- Melodica Intervention, Pulmonary Health Education
- Keywords
- Melodica, pursed lip breathing, breathing exercise, Music
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea, Emphysema, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melodica InterventionBehavioural
Also called Melodica Training Program
The melodica program will include education about pursed lip breathing, instruction in the melodica instrument, and participation in a melodica training group which meets twice-weekly for an 8-week period. Each session will include musical instruction, group music-making, and education about COPD and related health topics.
Pulmonary Health EducationBehavioural
A single session including education about COPD and related health topics.
| Study group | Role | What they receive |
|---|---|---|
| Melodica Intervention | Experimental | An 8-week group intervention including twice-weekly sessions. Each session will last one hour in duration with approximately 20 minutes for instruction, 30 minutes in group music-making, and 10 minutes allocated for educational information about COPD, tobacco cessation, and pulmonary rehabilitation. Receives: Behavioral: Melodica Intervention |
| Education Control | Active comparator | A single 90-120 minute education session including the same educational information about COPD, tobacco cessation, and pulmonary rehabilitation provided to the melodica intervention group. Receives: Behavioral: Pulmonary Health Education |
| Usual Care Control | No intervention | Usual care at Richard L. Roudebush VA Medical Center. |
| Interview Only | No intervention | Semi-structured interviews will be conducted with Veterans who meet eligibility criteria, but who do not agree to participate in the intervention, to identify potential barriers to participation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Adverse Events
We will describe the frequency with which patients reported any adverse events they experienced as a consequence of participation in the program as well as specify the types of adverse events.
Measured: Measured at baseline and before and after each of 16 program training sessions (8 week duration).
Safety: Dyspnea Visual Analog Line
We will measure dyspnea with a visual-analog line (100mm line with anchors at 0=no dyspnea, 100=severe dyspnea)
Measured: Baseline, before and after each training session (16 sessions over 8 weeks)
Secondary outcomes (2)
Feasibility: Program Participation
Feasibility will be measured in terms of the proportion of eligible Veterans who agree to participate
Measured: Measured at baseline
Feasibility: Attendance
Feasibility will be measured in terms of the proportion of sessions that enrolled participants attend
Measured: Measured at every intervention session (total of 16 sessions over 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start12 Jun 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Why it stopped: Did not initiate study intervention.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- This is a safety and feasibility pilot with a single intervention arm, an education control arm, a usual care control arm, and an interview only arm. The intervention arm includes participation in the melodica training program and education about pulmonary health. The education control arm includes pulmonary health education only. The interview only arm includes participation in a semi-structured interview about facilitators and barriers to participation.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Quality Enhancement Research Intiative
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dawn M. Bravata, VA Quality Enhancement Research Intiative
- Investigators
- Dawn M Bravata, MD, Principal investigator, VA Quality Enhancement Research Initiative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653104
- Sponsor's protocol ID
- 1802361245
- Acronym
- MELODY
- Status last verified
- Sep 2019
- First submitted
- 21 Aug 2018
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McGrath M, Smith J, Rattray NA, Lillie A, Crow S, Myers LJ, Myers J, Perkins AJ, Wasmuth S, Burns DS, Cheatham AJ, Patel H, Bravata DM. Teaching pursed-lip breathing through music: MELodica Orchestra for DYspnea (MELODY) trial rationale and protocol. Arts Health. 2022 Feb;14(1):49-65. doi: 10.1080/17533015.2020.1827277. Epub 2020 Oct 16.
PubMed 33064621
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melodica Orchestra for Dyspnea: Safety and Feasibility Pilot
- ClinicalTrials.gov ID
- NCT03653104
- Acronym / sponsor ID
- MELODY / 1802361245
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease, Dyspnea, Breathlessness, Emphysema, Chronic Bronchitis
- Keywords
- Melodica, pursed lip breathing, breathing exercise, Music
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Did not initiate study intervention.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VA Quality Enhancement Research IntiativeUniversity, hospital or other
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project seeks to pilot-test the feasibility of using a melodica training program to teach pursed lip breathing for Veterans with chronic obstructive pulmonary disease (COPD) with moderate to severe dyspnea (shortness of breath). Dyspnea occurs commonly among COPD patients and can limit activities of daily living. Pursed lip breathing is a strategy that can improve dyspnea and exercise capacity among COPD patients. The melodica is a musical instrument that looks like a keyboard with a mouthpiece on the side. The melodica is played by exhaling through the mouthpiece while pressing the keys. The MELODY pilot project protocol has been grounded on concepts from occupational therapy; specifically, providing participants with a meaningful new activity that is enjoyable, that can be provided across a spectrum of skill levels, that can provide participants with a new sense of self, and that can improve health outcomes (i.e., dyspnea and exercise endurance).
Detailed description
SPECIFIC AIMS:
Primary Aim 1: Evaluate the safety of a melodica training program to teach pursed lip breathing among Veterans with COPD with moderate to severe dyspnea. We hypothesize that a melodica training program can be safely implemented among COPD patients with severe dyspnea.
Primary Aim 2: Evaluate the feasibility of implementing a melodica training program to teach pursed lip breathing among Veterans with COPD with dyspnea. We hypothesize that it will be feasible to implement a melodica training program to teach pursed lip breathing among Veterans with COPD and dyspnea; specifically that enrolled participants will attend >50% of sessions. We also hypothesize that transportation to the VA Medical Center to attend sessions will be identified as a significant barrier to participation.
Secondary Aim: Collect pilot-efficacy data of a melodica training program to teach pursed lip breathing among Veterans with COPD and dyspnea. The objective is to understand whether melodica training improves dyspnea both in the short-term and in the longer-term over the course of the 8-week training program. We hypothesize that a melodica training program will reduce dyspnea by 30% in the short-term and 10% in the long-term. We also hypothesize that intervention participants will show gains in the secondary efficacy outcome measures of exercise endurance, pulmonary function, entering pulmonary rehabilitation, quality of life, patient global impression of change, and anxiety relative to controls.
RANDOMIZATION AND INTERVENTION:
Randomization:
Participants will be randomized in a 1:1:1 ratio to the intervention group (N=50), usual care control group (N=50), and education control group (N=50) using a block randomization design. We will also seek to identify N=30 Veterans who met the COPD diagnosis and spirometry eligibility criteria but who chose not to participate in the intervention; these Veterans will be invited to participate in a brief interview to identify barriers to participation.
Melodica Program Intervention:
The intervention program will include: education about pursed lip breathing, instruction in the melodica instrument, and participation in a melodica playing group which will meet twice-weekly for a 8-week period. Participants will be given instructional materials for use in practicing the instrument in their homes and encouragement to use pursed lip breathing not only while playing the instrument but also in their activities of daily living. Each session will last one hour in duration with approximately 20 minutes for instruction, 30 minutes in group music-making, and 10 minutes allocated for educational information about COPD, tobacco cessation, and pulmonary rehabilitation.
Education Group:
The patients in the education control group will receive the same educational materials that are provided to the intervention group; however, they will receive them in a single educational session. As described above, the educational materials include information about pursed lip breathing, COPD, medications used to treat COPD, how to use an inhaler, smoking cessation, pulmonary rehabilitation, oxygen therapy, exercise, and travelling with COPD. The materials include handouts as well as links to web pages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a safety and feasibility pilot with a single intervention arm, an education control arm, a usual care control arm, and an interview only arm. The intervention arm includes participation in the melodica training program and education about pulmonary health. The education control arm includes pulmonary health education only. The interview only arm includes participation in a semi-structured interview about facilitators and barriers to participation.
| Arm | Type | Receives |
|---|---|---|
| Melodica Intervention | Experimental | Behavioral: Melodica InterventionAn 8-week group intervention including twice-weekly sessions. Each session will last one hour in duration with approximately 20 minutes for instruction, 30 minutes in group music-making, and 10 minutes allocated for educational information about COPD, tobacco cessation, and pulmonary rehabilitation. |
| Education Control | Active comparator | Behavioral: Pulmonary Health EducationA single 90-120 minute education session including the same educational information about COPD, tobacco cessation, and pulmonary rehabilitation provided to the melodica intervention group. |
| Usual Care Control | No intervention | –Usual care at Richard L. Roudebush VA Medical Center. |
| Interview Only | No intervention | –Semi-structured interviews will be conducted with Veterans who meet eligibility criteria, but who do not agree to participate in the intervention, to identify potential barriers to participation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- spirometry-confirmed COPD defined as a FEV1/FVC <0.7
- moderate or severe dyspnea defined as a grade ≥3 on the ATS Dyspnea scale
Key exclusion criteria (7 listed)
- visual or hearing impairments
- do not speak English
- do not have an intact airway
- have cognitive impairment
- are unable to make a seal with their mouths
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 |
|---|---|---|
| Melodica InterventionAlso: Melodica Training ProgramThe melodica program will include education about pursed lip breathing, instruction in the melodica instrument, and participation in a melodica training group which meets twice-weekly for an 8-week period. Each session will include musical instruction, group music-making, and education about COPD and related health topics. | Behavioural | Melodica Intervention |
| Pulmonary Health EducationA single session including education about COPD and related health topics. | Behavioural | Education Control |
Primary outcome
Safety: Adverse Events
Time frame: Measured at baseline and before and after each of 16 program training sessions (8 week duration).
We will describe the frequency with which patients reported any adverse events they experienced as a consequence of participation in the program as well as specify the types of adverse events.
Safety: Dyspnea Visual Analog Line
Time frame: Baseline, before and after each training session (16 sessions over 8 weeks)
We will measure dyspnea with a visual-analog line (100mm line with anchors at 0=no dyspnea, 100=severe dyspnea)
2 secondary outcomes
Feasibility: Program Participation
Time frame: Measured at baseline
Feasibility: Attendance
Time frame: Measured at every intervention session (total of 16 sessions over 8 weeks)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
- Derived from this study: PubMed 33064621McGrath M, Smith J, Rattray NA, Lillie A, Crow S, Myers LJ, Myers J, Perkins AJ, Wasmuth S, Burns DS, Cheatham AJ, Patel H, Bravata DM. Teaching pursed-lip breathing through music: MELodica Orchestra for DYspnea (MELODY) trial rationale and protocol. Arts Health. 2022 Feb;14(1):49-65. doi: 10.1080/17533015.2020.1827277. Epub 2020 Oct 16.
- 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.
Dawn M Bravata, MD principal investigator
VA Quality Enhancement Research Initiative
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melodica Intervention and Pulmonary Health Education in people with COPD and Chronic Obstructive Pulmonary Disease, run by VA Quality Enhancement Research Intiative 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 2 inclusion and 7 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: withdrawn, as of the sponsor's last update on 15 Mar 2021. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Safety: Adverse Events (time frame: Measured at baseline and before and after each of 16 program training sessions (8 week duration).). 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?
On the ClinicalTrials.gov record for NCT03653104, which also lists 1 linked publication.
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 15 Mar 2021.