Melodica Orchestra for Dyspnea: Safety and Feasibility Pilot

Chronic Obstructive Pulmonary Disease Clinical Trial

— MELODY  

Official title:

Melodica Orchestra for Dyspnea: Safety and Feasibility Pilot

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03653104
• Other study ID #: 1802361245
• Status: Withdrawn
• Phase: N/A
• Start date: June 12, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2019
• Source: VA Quality Enhancement Research Intiative
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breathlessness
• Bronchitis
• Bronchitis, Chronic
• Chronic Bronchitis
• Chronic Obstructive Pulmonary Disease
• COPD
• Dyspnea
• Emphysema
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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 an 8-week period. Each session will include musical instruction, group music-making, and education about COPD and related health topics.
• Pulmonary Health Education
A single session including education about COPD and related health topics.

Locations

Country	Name	City	State
United States	Veteran Health Indiana, Richard L. Roudebush VA Medical Center	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
VA Quality Enhancement Research Intiative

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pilot-Efficacy: Dyspnea Visual Analog Line	We will measure dyspnea with a visual-analog line (100mm line with anchors at 0=no dyspnea, 100=severe dyspnea)	Baseline, before and after each intervention sessions (16 sessionis over 8 weeks).
Other	Secondary Efficacy: Quality of Life (SF-20)	We will assess quality of life based on the 20-item Short Form Health Survey (SF-20)	Measured at baseline, 4-weeks, 8-weeks
Other	Secondary Efficacy: Exercise Endurance (6-Minute Walk)	We will assess exercise endurance measured by the 6-Minute Walk Test (6MWT).	Measured at baseline, 4-weeks, 8-weeks
Primary	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 at baseline and before and after each of 16 program training sessions (8 week duration).
Primary	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)	Baseline, before and after each training session (16 sessions over 8 weeks)
Secondary	Feasibility: Program Participation	Feasibility will be measured in terms of the proportion of eligible Veterans who agree to participate	Measured at baseline
Secondary	Feasibility: Attendance	Feasibility will be measured in terms of the proportion of sessions that enrolled participants attend	Measured at every intervention session (total of 16 sessions over 8 weeks)