Study of AffloVest in At-Risk Respiratory Patients During COVID-19 Pandemic
Primary Purpose
Chronic Obstructive Pulmonary Disease, Chronic Cough, Covid19
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HCFWO
Standard Care Plus Monitoring
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring Pulmonary Disease, Airway Clearance Therapy, High Frequency Chest Wall Oscillation
Eligibility Criteria
Inclusion Criteria:
- Adult males and females ≥18 years
- Existing diagnosis of COPD for >6 months
- Chronic productive cough
- Radiographic evidence of flattening of the diaphragm
- Prior COVID-19 diagnosis
- Clinically followed by Mount Sinai COVID-19 Post Recovery and Respiratory Institute.
- Ability to provide informed consent
- Ability to read and fill out survey questionnaires via REDCap (surveys will be available in English and Spanish)
- Access to a home computer, tablet, or smartphone
Exclusion Criteria:
- Presenting with hypoxia (02 sat <90%)
- Acute COVID-19 infection
- Home oxygen dependent
- Established diagnosis of cystic fibrosis
- History of osteoporosis or rib fracture
- Active Hemoptysis
- Pneumothorax
Sites / Locations
- Mount Sinai Beth Israel
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Care Plus Monitoring
Standard Care Plus Monitoring and HCFWO
Arm Description
All subjects will be monitored via home spirometry, pulse oximetry, temperature checks, telehealth check-in and patient-reported outcome assessments.
In addition to home spirometry, pulse oximetry, temperature checks, telehealth check-in and patient-reported outcome assessments, subject will receive an Afflovest device for home use.
Outcomes
Primary Outcome Measures
Change in forced expiratory volume in one second (FEV1)
Change in forced expiratory volume in one second (FEV1) as compared to baseline, measured by home spirometer.
Change in Oxygen Saturation level
Changes in oxygen saturation from baseline as measured by pulse oximeter. Normal oxygen range is 95 to 100 percent and low oxygen range is under 90 percent.
Change in Presence of Fever
Changes in basal temperature as measured by digital thermometer. Fever is indicated at 100.4 F (38 C) or higher.
Secondary Outcome Measures
Change in Presence of pneumonia symptoms via Community Acquired Pneumonia (CAP) Symptom Questionnaire
CAP Symptom Questionnaire records how much the patient rated the bothersomeness of the symptom. Each item is scored as "0" (Patient did not have this symptom), "1" (Not at All) to "5" (Extremely). Full range scale from 0 to 90, higher score indicating patient experiencing more frequent or more severe symptoms.
Change in Quality of life via Quality of Life Questionnaire-Respiratory (QOL-B)
The QOL-B is a disease-specific questionnaire that measures symptoms, functioning, and health-related quality of life relevant to patients with bronchiectasis. Scores are generated from 37 items that fall on 8 domains: Physical Functioning, Role Functioning, Vitality, Emotional Functioning, Social Functioning, Treatment Burden, Health Perceptions, and Respiratory Symptoms. All subscales and the full range scale are standardized to score from 0 to 100, with higher scores indicating better enjoyment and satisfaction with specific life domains.
Change in Mental health screening via Personal Health Questionnaire Depression Scale (PHQ-8)
The PHQ-8 is the depression module, which scores each of the eight DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Full scale from 0-24, with higher score indicating more severe symptoms.
Change in Mental health screening via General Anxiety Disorder-7 (GAD-7)
The General Anxiety Disorder 7-item questionnaire (GAD-7) is a 7-item questionnaire that asks user to rank how often they have been bothered by seven problems over the past two weeks from "0" (not at all) to "3" (nearly every day). Full scale from 0-21, with higher score indicating more symptoms.
Change in COVID Symptom Checklist
Eight questions that are specific to recent literature describing patients' experiences of symptoms during COVID. They are rated on a frequency scale from "never" to "always," using a 1-4 point scale. Full scale range from 8 to 32, with higher scores indicating more frequent symptoms.
AffloVest Usage
Amount of time used per week in minutes
Full Information
NCT ID
NCT04654481
First Posted
December 3, 2020
Last Updated
April 29, 2022
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
International Biophysics Corporation, SPARK Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT04654481
Brief Title
Study of AffloVest in At-Risk Respiratory Patients During COVID-19 Pandemic
Official Title
Feasibility of Using a Home-Based High Frequency Chest Wall Oscillation Device (AffloVest) in At-Risk Respiratory Patients to Decrease Acute Respiratory Care Burden During the COVID-19 Pandemic
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
only one participant enrolled, results will not be provided due to risk of breach of confidentiality
Study Start Date
July 20, 2021 (Actual)
Primary Completion Date
October 19, 2021 (Actual)
Study Completion Date
October 19, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
International Biophysics Corporation, SPARK Healthcare
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
Brief Summary
The purpose of the study is to investigate the addition of high frequency chest wall oscillation (HFCWO) therapy to the prescribed care regimen to support the diaphragm during airway clearance among post-COVID patients with COPD and chronic productive cough as a way to limit the advancement of pulmonary symptoms and need for critical services during recovery from COVID-19.
Detailed Description
Thirty study participants in New York City who meet inclusion criteria will be recruited from Mount Sinai's COVID-19 Post-Recovery Center of Excellence and Respiratory Institute. Fifteen subjects (determined by the last digit of their medical record number) will receive a HFCWO device (AffloVest), digital thermometer, pulse oximeter, and spirometer at their home. Participants will be trained remotely to use the AffloVest and spirometer. In addition all subjects will be asked to complete a series of online mental health and respiratory symptom assessments via REDCap. A 15 patient control group meeting inclusion criteria will be recruited from the Mount Sinai COVID-19 Post-Recovery Center of Excellence and Respiratory Institute using the same screening process. This group will not receive the HFCWO intervention but will receive a digital thermometer, pulse oximeter, and spirometer at their home (with training via telehealth), asked to complete all REDCap and respiratory symptom assessments. Consent for both groups will be obtained by a Mount Sinai clinician-researcher.
Study Duration Approximately 30 days plus 60 and 90-day check in
Objectives To investigate the addition of HFCWO therapy to the prescribed care regimen to support the diaphragm during airway clearance among post-COVID patients with COPD and chronic productive cough as a way to limit the advancement of pulmonary symptoms and need for critical services during recovery from COVID-19.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Chronic Cough, Covid19
Keywords
Pulmonary Disease, Airway Clearance Therapy, High Frequency Chest Wall Oscillation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Statistician and data analysts will be blinded to treatment cohort.
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Care Plus Monitoring
Arm Type
Active Comparator
Arm Description
All subjects will be monitored via home spirometry, pulse oximetry, temperature checks, telehealth check-in and patient-reported outcome assessments.
Arm Title
Standard Care Plus Monitoring and HCFWO
Arm Type
Experimental
Arm Description
In addition to home spirometry, pulse oximetry, temperature checks, telehealth check-in and patient-reported outcome assessments, subject will receive an Afflovest device for home use.
Intervention Type
Device
Intervention Name(s)
HCFWO
Other Intervention Name(s)
High Frequency Chest Wall Oscillation, Afflovest
Intervention Description
The Afflovest device is a High Frequency Chest Wall Oscillation (HFCWO) device, a medical vest that uses vibrations to loosen and mobilize mucus in the lung secretions and help clear the airways.
Intervention Type
Other
Intervention Name(s)
Standard Care Plus Monitoring
Intervention Description
Monitoring via home spirometry, pulse oximetry, temperature checks, telehealth check-in and patient-reported outcome assessments.
Primary Outcome Measure Information:
Title
Change in forced expiratory volume in one second (FEV1)
Description
Change in forced expiratory volume in one second (FEV1) as compared to baseline, measured by home spirometer.
Time Frame
Baseline and up to 90 Days
Title
Change in Oxygen Saturation level
Description
Changes in oxygen saturation from baseline as measured by pulse oximeter. Normal oxygen range is 95 to 100 percent and low oxygen range is under 90 percent.
Time Frame
Baseline and up to 90 Days
Title
Change in Presence of Fever
Description
Changes in basal temperature as measured by digital thermometer. Fever is indicated at 100.4 F (38 C) or higher.
Time Frame
Baseline and up to 90 Days
Secondary Outcome Measure Information:
Title
Change in Presence of pneumonia symptoms via Community Acquired Pneumonia (CAP) Symptom Questionnaire
Description
CAP Symptom Questionnaire records how much the patient rated the bothersomeness of the symptom. Each item is scored as "0" (Patient did not have this symptom), "1" (Not at All) to "5" (Extremely). Full range scale from 0 to 90, higher score indicating patient experiencing more frequent or more severe symptoms.
Time Frame
Baseline and up to 90 Days
Title
Change in Quality of life via Quality of Life Questionnaire-Respiratory (QOL-B)
Description
The QOL-B is a disease-specific questionnaire that measures symptoms, functioning, and health-related quality of life relevant to patients with bronchiectasis. Scores are generated from 37 items that fall on 8 domains: Physical Functioning, Role Functioning, Vitality, Emotional Functioning, Social Functioning, Treatment Burden, Health Perceptions, and Respiratory Symptoms. All subscales and the full range scale are standardized to score from 0 to 100, with higher scores indicating better enjoyment and satisfaction with specific life domains.
Time Frame
Baseline and up to 90 Days
Title
Change in Mental health screening via Personal Health Questionnaire Depression Scale (PHQ-8)
Description
The PHQ-8 is the depression module, which scores each of the eight DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Full scale from 0-24, with higher score indicating more severe symptoms.
Time Frame
Baseline and up to 90 Days
Title
Change in Mental health screening via General Anxiety Disorder-7 (GAD-7)
Description
The General Anxiety Disorder 7-item questionnaire (GAD-7) is a 7-item questionnaire that asks user to rank how often they have been bothered by seven problems over the past two weeks from "0" (not at all) to "3" (nearly every day). Full scale from 0-21, with higher score indicating more symptoms.
Time Frame
Baseline and up to 90 Days
Title
Change in COVID Symptom Checklist
Description
Eight questions that are specific to recent literature describing patients' experiences of symptoms during COVID. They are rated on a frequency scale from "never" to "always," using a 1-4 point scale. Full scale range from 8 to 32, with higher scores indicating more frequent symptoms.
Time Frame
Baseline and up to 90 Days
Title
AffloVest Usage
Description
Amount of time used per week in minutes
Time Frame
90 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult males and females ≥18 years
Existing diagnosis of COPD for >6 months
Chronic productive cough
Radiographic evidence of flattening of the diaphragm
Prior COVID-19 diagnosis
Clinically followed by Mount Sinai COVID-19 Post Recovery and Respiratory Institute.
Ability to provide informed consent
Ability to read and fill out survey questionnaires via REDCap (surveys will be available in English and Spanish)
Access to a home computer, tablet, or smartphone
Exclusion Criteria:
Presenting with hypoxia (02 sat <90%)
Acute COVID-19 infection
Home oxygen dependent
Established diagnosis of cystic fibrosis
History of osteoporosis or rib fracture
Active Hemoptysis
Pneumothorax
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Walker, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Beth Israel
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of AffloVest in At-Risk Respiratory Patients During COVID-19 Pandemic
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