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 : September 28, 2018
|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|
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:
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.
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|
|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|
|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|
Experimental: Melodica Intervention
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.
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.
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
- 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)
- Feasibility: Program Participation [ Time Frame: Measured at baseline ]Feasibility will be measured in terms of the proportion of eligible Veterans who agree to participate
- Feasibility: Attendance [ Time Frame: Measured at every intervention session (total of 16 sessions over 8 weeks) ]Feasibility will be measured in terms of the proportion of sessions that enrolled participants attend
- Pilot-Efficacy: Dyspnea Visual Analog Line [ Time Frame: Baseline, before and after each intervention sessions (16 sessionis over 8 weeks). ]We will measure dyspnea with a visual-analog line (100mm line with anchors at 0=no dyspnea, 100=severe dyspnea)
- Secondary Efficacy: Quality of Life (SF-20) [ Time Frame: Measured at baseline, 4-weeks, 8-weeks ]We will assess quality of life based on the 20-item Short Form Health Survey (SF-20)
- Secondary Efficacy: Exercise Endurance (6-Minute Walk) [ Time Frame: Measured at baseline, 4-weeks, 8-weeks ]We will assess exercise endurance measured by the 6-Minute Walk Test (6MWT).
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
|Contact: Aimee N Lillie, B.S.||firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Dawn M Bravata, MD|
|Principal Investigator:||Dawn M Bravata, MD||VA Quality Enhancement Research Initiative|