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Melodica Orchestra for Dyspnea: Safety and Feasibility Pilot (MELODY)

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ClinicalTrials.gov Identifier: NCT03653104
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Dawn M. Bravata, VA Quality Enhancement Research Intiative

Brief 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. 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).

Condition or disease Intervention/treatment Phase
COPD Chronic Obstructive Pulmonary Disease Dyspnea Breathlessness Emphysema Chronic Bronchitis Behavioral: Melodica Intervention Behavioral: Pulmonary Health Education Not Applicable

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 12-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 12-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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Masking Description: No masking
Primary Purpose: Treatment
Official Title: Melodica Orchestra for Dyspnea: Safety and Feasibility Pilot
Actual Study Start Date : June 12, 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Melodica Intervention
A 12-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.
Behavioral: Melodica Intervention
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 a 12-week period. Each session will include musical instruction, group music-making, and education about COPD and related health topics.
Other Name: Melodica Training Program

Active Comparator: Education Control
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.
Behavioral: Pulmonary Health Education
A single session including education about COPD and related health topics.

No Intervention: Usual Care Control
Usual care at Richard L. Roudebush VA Medical Center.
No Intervention: Interview Only
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



Primary Outcome Measures :
  1. Safety: Adverse Events [ Time Frame: Measured at baseline and before and after each of 24 program training sessions (12 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.

  2. Safety: Dyspnea Visual Analog Line [ Time Frame: Baseline, before and after each training session (24 sessions over 12 weeks) ]
    We will measure dyspnea with a visual-analog line (100mm line with anchors at 0=no dyspnea, 100=severe dyspnea)


Secondary Outcome Measures :
  1. Feasibility: Program Participation [ Time Frame: Measured at baseline ]
    Feasibility will be measured in terms of the proportion of eligible Veterans who agree to participate

  2. Feasibility: Attendance [ Time Frame: Measured at every intervention session (total of 24 sessions over 12 weeks) ]
    Feasibility will be measured in terms of the proportion of sessions that enrolled participants attend


Other Outcome Measures:
  1. Pilot-Efficacy: Dyspnea Visual Analog Line [ Time Frame: Baseline, before and after each intervention sessions (24 sessionis over 12 weeks). ]
    We will measure dyspnea with a visual-analog line (100mm line with anchors at 0=no dyspnea, 100=severe dyspnea)

  2. Secondary Efficacy: Quality of Life (SF-20) [ Time Frame: Measured at baseline, 4-weeks, 8-weeks, 12-weeks. ]
    We will assess quality of life based on the 20-item Short Form Health Survey (SF-20)

  3. Secondary Efficacy: Exercise Endurance (6-Minute Walk) [ Time Frame: Measured at baseline, 4-weeks, 8-weeks, 12-weeks. ]
    We will assess exercise endurance measured by the 6-Minute Walk Test (6MWT).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • spirometry-confirmed COPD defined as a FEV1/FVC <0.7
  • moderate or severe dyspnea defined as a grade ≥3 on the ATS Dyspnea scale

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653104


Contacts
Contact: Aimee N Lillie, B.S. 317-988-9712 aimee.lillie@va.gov

Locations
United States, Indiana
Veteran Health Indiana, Richard L. Roudebush VA Medical Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Aimee N Lillie, B.S.    317-988-9712    aimee.lillie@va.gov   
Principal Investigator: Dawn M Bravata, MD         
Sponsors and Collaborators
VA Quality Enhancement Research Intiative
Investigators
Principal Investigator: Dawn M Bravata, MD VA Quality Enhancement Research Initiative

Responsible Party: Dawn M. Bravata, Professor of Medicine & Adjunct Professor of Neurology, VA Quality Enhancement Research Intiative
ClinicalTrials.gov Identifier: NCT03653104     History of Changes
Other Study ID Numbers: 1802361245
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dawn M. Bravata, VA Quality Enhancement Research Intiative:
Melodica
pursed lip breathing
breathing exercise
Music

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Emphysema
Dyspnea
Bronchitis
Bronchitis, Chronic
Respiratory Tract Diseases
Pathologic Processes
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Bronchial Diseases
Respiratory Tract Infections