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| ID | Type | Description | Link |
|---|---|---|---|
| 20-00751 | Other Identifier | NYU Langone Health | |
| R34AT010673 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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This pilot study is part of a phased approach to refine, optimize, and test the feasibility of CALM Breathing. Preliminary participant feedback from the Capnography-Assisted Respiratory Therapy (CART) study was applied to adapt and design CALM Breathing (including its dose, schedule, delivery, and home program). This pilot builds on initial lessons learned and identifies intervention areas still needing greater development to assure the success of a future large trial, targeting a subpopulation at risk, that is, those with COPD and anxiety sensitivity.
The purpose of this study is to evaluate an experimental breathing therapy for adults with chronic obstructive pulmonary disease (COPD) called Capnography-Assisted Learned, Monitored (CALM) Breathing. CALM Breathing is an experimental therapy that uses exercises combined with breathing feedback. CALM Breathing promotes self-regulated breathing to relieve symptoms. In sessions, biofeedback of breathing is predominately provided by two devices that are cleared by the Food and Drug Administration (FDA) to measure carbon dioxide at the end of a breath and breathing rate. A capnograph uses tubing at the nose to evaluate levels of carbon dioxide and breathing rate from exhaled air and to display breathing patterns. A pulse oximeter for home use also evaluates breathing rate at the fingertip with a sensor that detects blood flow changes. The investigators are studying CALM Breathing to see if it can relieve shortness of breath and other symptoms; reduce stress; and improve quality of life and exercise tolerance in adults with COPD. The investigators are planning to recruit up to approximately 65 subjects with COPD at Columbia University Irving Medical Center. Participants will be assigned by chance into one of two treatment groups: 1) CALM Breathing or Usual Care (Waitlist). Participants will have an equal chance of being assigned to either group. CALM Breathing is a 4-week therapy program that uses breathing exercises with biofeedback to reduce shortness of breath and other symptoms related to COPD. Biofeedback uses sensors to give information about breathing pattern and airflow to help participants better self-regulate their breathing. Participants assigned by chance to CALM Breathing, will participate in eight breathing therapy sessions, provided twice per week; each session will each take approximately 1-hour. All participants will receive 16-20 standard care pulmonary rehabilitation sessions beginning at approximately week 6-10. Participants will complete three study evaluation visits (at baseline, ~6 weeks, and at a 3-month follow-up).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CALM Breathing | Experimental |
| |
| Wait-List Control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CALM Breathing | Behavioral | CALM Breathing is a mind-body breathing therapy that links CO2 changes to dyspnea and anxiety symptoms and targets breathing efficiency and self-efficacy in COPD. CALM Breathing: Individual interoception- based breathing therapy with capnography (non- exercise training) Home Program: Monitored home- based breathing exercises; RR biofeedback; goal setting; exercise logging. Coaching: Motivational interviewing. Personnel: PT, EP, occupational therapist, or nurse. Frequency: 1-hour sessions, twice per week for 4 weeks. Exercises: • 10 core breathing exercises with ETCO2 biofeedback in recovery postures at rest and with body movement (gentle stretches and brief low-moderate intensity physical activity). • Breathing biofeedback (ETCO2, RR, airflow pattern). Education: Education on anxiety; COPD Patient Guide. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Attendance Rate of CALM Breathing Treatment Sessions | Attendance rate will be measured from the total number of sessions completed out of the 8 total. | 4 weeks |
| Drop-Out Rate | The drop-out rate will be calculated from the total number of participants who drop-out from receiving the CALM Breathing therapy. | 3 months |
| CALM Breathing Satisfaction Rating | The acceptability of the CALM Breathing therapy will be evaluated based on mixed methods data collected from CALM Breathing satisfaction ratings. Participants were asked item 8 of FACIT ("how do rate this treatment overall?"), which was rated from 0 to 4 (0 = "poor" and 4 = "excellent") in which higher scores indicate more satisfaction (better outcome). | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Chronic Respiratory Disease Questionnaire (CRQ) Score | This questionnaire measures the impact of chronic obstructive pulmonary disease (COPD) on a person's life. It consists of 20 items across 4 domains (dyspnea, fatigue, emotional function, and master). Items are on a 7-point Likert scale (1 - 7) and are scored from 1 (most severe) to 7 (no impairment) (better outcome). For this trial, questions 4a- 4e are included which is the dyspnea domain. The 5 scores are summated and divided by the number of items. The range is 1-7. Higher scores indicate better outcomes. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Evaluation of Breathing Questionnaire (SEBQ) Score | The SEBQ contains 12 items and assesses the patient's perception of their breathing difficulties and gives an insight into the effort of breathing and the feeling of air hunger. Responses to these items are on a 4-point Likert scale: (0) never/not true at all; (1) occasionally/a bit true; (2) frequently-mostly true; and, (3) very frequently/very true. SEBQ scores for sum of the original items ranged from 0 to 36, with a lower total indicating a better outcome. |
Inclusion Criteria:
be adult males or females
have a diagnosis of COPD as defined by FEV1/FVC of < 0.70 on spirometry testing or as shown on a chest computed tomography (CT)
receive standard care of pharmacotherapy with bronchodilators (e.g. long-acting beta-agonists, LABAs, or long-acting muscarinic antagonists, or LAMAs) as prescribed by their physician
are in stable medical condition as determined by pulmonary rehabilitation physician (i.e., not in need of acute higher level of care such as hospitalization)
have dyspnea [as documented in their medical record or based on self-report; e.g., ≥1 on modified Medical Research Council questionnaire (mMRC) dyspnea; or ≥2 dyspnea score on item: "Over the last 4 weeks, I have had shortness of breath: almost every day = 4, several days a week = 3, a few days a month = 2, only with lung/respiratory infections = 1, not at all = 0; or "yes" response of binary presence of dyspnea-related avoidance of activities: "Have you avoided any activities due to shortness of breath?")]
have elevated dyspnea-related anxiety symptoms:
require ≤ 24 hours per day of supplemental oxygen
Mini-Mental State Examination score ≥24
speak, read, and write English
are stably medicated for at least 4 weeks prior to study entry with long-acting anti-anxiety medication (e.g., selective serotonin reuptake inhibitors, SSRIs, and serotonin norepinephrine reuptake inhibitors, SNRIs), benzodiazepines, or cannabis if prescribed, with no plans to change psychotropic medication dose
have not received any pulmonary rehabilitation training in the past 12 months.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Norweg, PhD, OTR | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University Grossman School of Medicine | New York | New York | 10016 | United States | ||
| Columbia University Irving Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39976559 | Derived | Norweg A, Oh C, DiMango A, Hofferber B, Spinner M, Stavrolakes K, Pavol M, Lindenauer P, Murphy CG, Simon NM. Mind the Breath: Feasibility of Capnography-Assisted Learned Monitored (CALM) Breathing for Dyspnea Treatment. J Cardiopulm Rehabil Prev. 2025 Mar 1;45(2):118-131. doi: 10.1097/HCR.0000000000000939. Epub 2025 Feb 13. |
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The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with Columbia University. Requests may be directed to the Principal Investigator (PI). The protocol and statistical analysis plan will be made available on ClinicalTrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements
Requests may be directed to the PI.
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| ID | Title | Description |
|---|---|---|
| FG000 | CALM Breathing | CALM Breathing: CALM Breathing is a mind-body breathing therapy that links CO2 changes to dyspnea and anxiety symptoms and targets breathing efficiency and self-efficacy in COPD. CALM Breathing: Individual interoception- based breathing therapy with capnography (non- exercise training) Home Program: Monitored home- based breathing exercises; RR biofeedback; goal setting; exercise logging. Coaching: Motivational interviewing. Personnel: PT, EP, occupational therapist, or nurse. Frequency: 1-hour sessions, twice per week for 4 weeks. Exercises: • 10 core breathing exercises with ETCO2 biofeedback in recovery postures at rest and with body movement (gentle stretches and brief low-moderate intensity physical activity). • Breathing biofeedback (ETCO2, RR, airflow pattern). Education: Education on anxiety; COPD Patient Guide. |
| FG001 | Wait-List Control | Traditional outpatient PR: After referral to Columbia's outpatient pulmonary rehabilitation (PR) program, participants randomized to the Wait-List control group will be put on a PR wait list (usual care). In Phase II, all participants will receive PR of 1-hour sessions, twice per week for 10 weeks. Traditional outpatient PR: Group exercise training (ET) combined with pursed lips breathing (PLB) training; 1:2 therapist to patient ratio. Home Program: Unmonitored walking exercise 1-2 days/week; no biofeedback monitoring. Coaching: Traditional monitoring and verbal cueing. Personnel: PT or EP. Frequency: 1-hour sessions, twice per week for 10 weeks. Exercises: • ET of muscles of ambulation with exercise equipment, such as on a treadmill or cycle ergometer (30-min), plus 15-min strengthening and posture exercises; O2 supplementation as needed. No breathing biofeedback. • PLB instruction only during exercise training. Education: Verbal and written information. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CALM Breathing | CALM Breathing: CALM Breathing is a mind-body breathing therapy that links CO2 changes to dyspnea and anxiety symptoms and targets breathing efficiency and self-efficacy in COPD. CALM Breathing: Individual interoception- based breathing therapy with capnography (non- exercise training) Home Program: Monitored home- based breathing exercises; RR biofeedback; goal setting; exercise logging. Coaching: Motivational interviewing. Personnel: PT, EP, occupational therapist, or nurse. Frequency: 1-hour sessions, twice per week for 4 weeks. Exercises: • 10 core breathing exercises with ETCO2 biofeedback in recovery postures at rest and with body movement (gentle stretches and brief low-moderate intensity physical activity). • Breathing biofeedback (ETCO2, RR, airflow pattern). Education: Education on anxiety; COPD Patient Guide. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Attendance Rate of CALM Breathing Treatment Sessions | Attendance rate will be measured from the total number of sessions completed out of the 8 total. | This outcome measure is only measuring attendance for individuals who received the CALM breathing intervention. | Posted | Mean | Full Range | percentage of completed sessions | 4 weeks |
|
AE data was collected over 3 months from baseline or until the participants completed/withdrew from the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | All AEs that occurred for any study participant was recorded but not stratified per arm. AEs were not collected per arm and therefore stratified data is not available. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Tightness | Cardiac disorders | Systematic Assessment | 1 hospitalization due to chest tightness. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomach Flu | Infections and infestations | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Annamaria Norweg, PhD | Columbia University | 212-305-1651 | amn2212@cumc.columbia.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 22, 2022 | Jan 2, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 22, 2022 | Jan 2, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 11, 2022 | Jan 2, 2024 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D053120 | Respiratory Aspiration |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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A prospective RCT: In Phase I, participants will be randomized 1:1 to one of two groups: CALM Breathing (N = 25) and Wait-List control (N = 25). In Phase II, both groups will be offered Columbia University's 10-week PR program (care as usual). Access to timely initiation of PR will be facilitated. We will use a hybrid design to evaluate feasibility and acceptability.
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Outcome assessment
|
| Traditional outpatient PR | Behavioral | After referral to Columbia's outpatient pulmonary rehabilitation (PR) program, participants randomized to the Wait-List control group will be put on a PR wait list (usual care). In Phase II, all participants will receive PR of 1-hour sessions, twice per week for 10 weeks. Traditional outpatient PR: Group exercise training (ET) combined with pursed lips breathing (PLB) training; 1:2 therapist to patient ratio. Home Program: Unmonitored walking exercise 1-2 days/week; no biofeedback monitoring. Coaching: Traditional monitoring and verbal cueing. Personnel: PT or EP. Frequency: 1-hour sessions, twice per week for 10 weeks. Exercises: • ET of muscles of ambulation with exercise equipment, such as on a treadmill or cycle ergometer (30-min), plus 15-min strengthening and posture exercises; O2 supplementation as needed. No breathing biofeedback. • PLB instruction only during exercise training. Education: Verbal and written information. |
|
| Baseline, 4 weeks, 3 months |
| Dyspnea Management Questionnaire Computer Adaptive Test (DMQ-CAT) Score | The DMQ-CAT is a 71-item questionnaire that measures dyspnea anxiety. Raw scores range from 0 (low) to 6 (high). These raw scores are converted into T-scores with a mean score of 50 and a standard deviation of ±10. The full range of T-scores is 0 to 100 for DMQ-CAT Self-Efficacy, DMQ-CAT Intensity and DMQ-CAT Anxiety scales. The DMQ-CAT software automatically scores these scales. Higher scores indicate better outcomes. | 4 weeks |
| Dyspnea Management Questionnaire Computer Adaptive Test (DMQ-CAT) Score | The DMQ-CAT is a 71-item questionnaire that measures dyspnea anxiety. Raw scores range from 0 (low) to 6 (high). These raw scores are converted into T-scores with a mean score of 50 and a standard deviation of ±10. The full range of T-scores is 0 to 100 for DMQ-CAT Self-Efficacy, DMQ-CAT Intensity and DMQ-CAT Anxiety scales. The DQM-CAT software automatically scores these scales. Higher scores indicate better outcomes. | 3 months |
| Modified Borg Scale Score | The Modified Borg Scale is most commonly used to assess symptoms of breathlessness. On the 11-item scale, a score of 0 indicates "No Exertion" and a score of 10 indicates "Maximal" exertion (10-point scale). The full range is 0-10 for Borg-Dyspnea and Borg-Fatigue. Higher scores indicate worse outcomes (i.e. more exertion). | 4 weeks |
| Modified Borg Scale Score | The Modified Borg Scale is most commonly used to assess symptoms of breathlessness. On the 11-item scale, a score of 0 indicates "No Exertion" and a score of 10 indicates "Maximal" exertion (10-point scale). The full range is 0-10 for Borg-Dyspnea and Borg-Fatigue. Higher scores indicate worse outcomes (i.e. more exertion). | 3 months |
| Generalized Anxiety Disorder-7 (GAD-7) Score | The General Anxiety Disorder-7 is a 7-item screening tool and symptom severity measure for the four most common anxiety disorders. This is calculated by assigning scores of 0 ("not at all"), 1 ("several days'), 2 ("more than half the days"), or 3 ("nearly every day"). GAD-7 total score for the seven items ranges from 0 to 21. Higher scores indicate worse outcomes (i.e. greater anxiety). | 3 months |
| Perceived Stress Scale Score (PSS) | The PSS is a 10-item classic stress assessment instrument. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. | Baseline, 4 weeks, 3 months |
| 6 Mile Walking Distance Score (6MWT) | This is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. | Baseline, 4 weeks, 3 months |
| Physical Activity Scale for the Elderly (PASE) | This 12-item questionnaire uses frequency, duration, and intensity level of activity over the previous week to assign a score, ranging from 0 to 793, with higher scores indicating greater physical activity. | 3 months |
| Change in COPD Assessment Test (CAT) Score | The CAT quantifies the impact of COPD symptoms on patients' overall health. Participants assign a score ranging from 0 to 5 for each of the 8 areas. A score of 0 means there is no impairment in that area. A score of 5 means severe impairment. The overall score will range from 0 to 40. The score is a composite score. | 4 weeks, 3 months |
| Patient-Reported Outcomes Measurement Information System (PROMIS-24). | This is a 10-item tool used to measure patient-reported outcomes (PROs) relevant across common medical conditions. The response options are presented as a 5-point rating scale, with higher scores indicating a healthier patient (better outcome). Scores are standardized to the general population using the "T-Score", with the average T-score for the US population is 50 points, with a SD of 10 points. This applies to PROMIS Social, PROMIS Fatigue, PROMIS Physical, and PROMIS Sleep Disturbance. | 4 weeks |
| Patient-Reported Outcomes Measurement Information System (PROMIS-24). | This is a 10-item tool used to measure patient-reported outcomes (PROs) relevant across common medical conditions. The response options are presented as a 5-point rating scale, with higher scores indicating a healthier patient (better outcome). Scores are standardized to the general population using the "T-Score", with the average T-score for the US population is 50 points, with a SD of 10 points. This applies to PROMIS Social, PROMIS Fatigue, PROMIS Physical, and PROMIS Sleep Disturbance. | 3 months |
| End-tidal CO2 | This measures the partial pressure of CO2 at the end of an exhaled breath. | Baseline, 4 weeks, 3 months |
| Patient Activation Measure (PAM) Score | Pulmonary Rehabilitation Engagement will be measured using the Patient Activation Measure (PAM), which is a 10 or 13 item questionnaire that measures patients on a 0-100 scale and can segment patients into one of four activation levels along an empirically derived continuum. Each activation level reveals insight into an array of health-related characteristics, including attitudes, motivators, behaviors, and outcomes. A higher score indicates a better outcome. | Baseline, 4 weeks, 3 months |
| Baseline, 4 weeks, 3 months |
| New York |
| New York |
| 10032 |
| United States |
| Lost to Follow-up |
|
| BG001 | Wait-List Control | Traditional outpatient PR: After referral to Columbia's outpatient pulmonary rehabilitation (PR) program, participants randomized to the Wait-List control group will be put on a PR wait list (usual care). In Phase II, all participants will receive PR of 1-hour sessions, twice per week for 10 weeks. Traditional outpatient PR: Group exercise training (ET) combined with pursed lips breathing (PLB) training; 1:2 therapist to patient ratio. Home Program: Unmonitored walking exercise 1-2 days/week; no biofeedback monitoring. Coaching: Traditional monitoring and verbal cueing. Personnel: PT or EP. Frequency: 1-hour sessions, twice per week for 10 weeks. Exercises: • ET of muscles of ambulation with exercise equipment, such as on a treadmill or cycle ergometer (30-min), plus 15-min strengthening and posture exercises; O2 supplementation as needed. No breathing biofeedback. • PLB instruction only during exercise training. Education: Verbal and written information. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Supplemental Oxygen (home use) | Count of Participants | Participants |
|
|
|
| Primary | Drop-Out Rate | The drop-out rate will be calculated from the total number of participants who drop-out from receiving the CALM Breathing therapy. | This outcome measure is only looking to measure the drop-out rate for the CALM Breathing arm. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Primary | CALM Breathing Satisfaction Rating | The acceptability of the CALM Breathing therapy will be evaluated based on mixed methods data collected from CALM Breathing satisfaction ratings. Participants were asked item 8 of FACIT ("how do rate this treatment overall?"), which was rated from 0 to 4 (0 = "poor" and 4 = "excellent") in which higher scores indicate more satisfaction (better outcome). | Only data from the 17 participants who completed the satisfaction questionnaire from the CALM Breathing arm was collected and analyzed. | Posted | Mean | Full Range | score on a scale | 4 weeks |
|
|
|
| Secondary | Chronic Respiratory Disease Questionnaire (CRQ) Score | This questionnaire measures the impact of chronic obstructive pulmonary disease (COPD) on a person's life. It consists of 20 items across 4 domains (dyspnea, fatigue, emotional function, and master). Items are on a 7-point Likert scale (1 - 7) and are scored from 1 (most severe) to 7 (no impairment) (better outcome). For this trial, questions 4a- 4e are included which is the dyspnea domain. The 5 scores are summated and divided by the number of items. The range is 1-7. Higher scores indicate better outcomes. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 weeks, 3 months |
|
|
|
| Secondary | Dyspnea Management Questionnaire Computer Adaptive Test (DMQ-CAT) Score | The DMQ-CAT is a 71-item questionnaire that measures dyspnea anxiety. Raw scores range from 0 (low) to 6 (high). These raw scores are converted into T-scores with a mean score of 50 and a standard deviation of ±10. The full range of T-scores is 0 to 100 for DMQ-CAT Self-Efficacy, DMQ-CAT Intensity and DMQ-CAT Anxiety scales. The DMQ-CAT software automatically scores these scales. Higher scores indicate better outcomes. | Posted | Mean | Standard Deviation | T-score | 4 weeks |
|
|
|
| Secondary | Dyspnea Management Questionnaire Computer Adaptive Test (DMQ-CAT) Score | The DMQ-CAT is a 71-item questionnaire that measures dyspnea anxiety. Raw scores range from 0 (low) to 6 (high). These raw scores are converted into T-scores with a mean score of 50 and a standard deviation of ±10. The full range of T-scores is 0 to 100 for DMQ-CAT Self-Efficacy, DMQ-CAT Intensity and DMQ-CAT Anxiety scales. The DQM-CAT software automatically scores these scales. Higher scores indicate better outcomes. | Posted | Mean | Standard Deviation | T-score | 3 months |
|
|
|
| Secondary | Modified Borg Scale Score | The Modified Borg Scale is most commonly used to assess symptoms of breathlessness. On the 11-item scale, a score of 0 indicates "No Exertion" and a score of 10 indicates "Maximal" exertion (10-point scale). The full range is 0-10 for Borg-Dyspnea and Borg-Fatigue. Higher scores indicate worse outcomes (i.e. more exertion). | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
|
|
|
| Secondary | Modified Borg Scale Score | The Modified Borg Scale is most commonly used to assess symptoms of breathlessness. On the 11-item scale, a score of 0 indicates "No Exertion" and a score of 10 indicates "Maximal" exertion (10-point scale). The full range is 0-10 for Borg-Dyspnea and Borg-Fatigue. Higher scores indicate worse outcomes (i.e. more exertion). | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Secondary | Generalized Anxiety Disorder-7 (GAD-7) Score | The General Anxiety Disorder-7 is a 7-item screening tool and symptom severity measure for the four most common anxiety disorders. This is calculated by assigning scores of 0 ("not at all"), 1 ("several days'), 2 ("more than half the days"), or 3 ("nearly every day"). GAD-7 total score for the seven items ranges from 0 to 21. Higher scores indicate worse outcomes (i.e. greater anxiety). | Data was not collected. | Posted | 3 months |
|
|
| Secondary | Perceived Stress Scale Score (PSS) | The PSS is a 10-item classic stress assessment instrument. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 weeks, 3 months |
|
|
|
| Secondary | 6 Mile Walking Distance Score (6MWT) | This is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. | Posted | Mean | Standard Deviation | meters | Baseline, 4 weeks, 3 months |
|
|
|
| Secondary | Physical Activity Scale for the Elderly (PASE) | This 12-item questionnaire uses frequency, duration, and intensity level of activity over the previous week to assign a score, ranging from 0 to 793, with higher scores indicating greater physical activity. | Data was not collected for this analysis. | Posted | 3 months |
|
|
| Secondary | Change in COPD Assessment Test (CAT) Score | The CAT quantifies the impact of COPD symptoms on patients' overall health. Participants assign a score ranging from 0 to 5 for each of the 8 areas. A score of 0 means there is no impairment in that area. A score of 5 means severe impairment. The overall score will range from 0 to 40. The score is a composite score. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks, 3 months |
|
|
|
| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS-24). | This is a 10-item tool used to measure patient-reported outcomes (PROs) relevant across common medical conditions. The response options are presented as a 5-point rating scale, with higher scores indicating a healthier patient (better outcome). Scores are standardized to the general population using the "T-Score", with the average T-score for the US population is 50 points, with a SD of 10 points. This applies to PROMIS Social, PROMIS Fatigue, PROMIS Physical, and PROMIS Sleep Disturbance. | Posted | Mean | Standard Deviation | T-score | 4 weeks |
|
|
|
| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS-24). | This is a 10-item tool used to measure patient-reported outcomes (PROs) relevant across common medical conditions. The response options are presented as a 5-point rating scale, with higher scores indicating a healthier patient (better outcome). Scores are standardized to the general population using the "T-Score", with the average T-score for the US population is 50 points, with a SD of 10 points. This applies to PROMIS Social, PROMIS Fatigue, PROMIS Physical, and PROMIS Sleep Disturbance. | Posted | Mean | Standard Deviation | T-score | 3 months |
|
|
|
| Secondary | End-tidal CO2 | This measures the partial pressure of CO2 at the end of an exhaled breath. | Posted | Mean | Standard Deviation | mmHg | Baseline, 4 weeks, 3 months |
|
|
|
| Secondary | Patient Activation Measure (PAM) Score | Pulmonary Rehabilitation Engagement will be measured using the Patient Activation Measure (PAM), which is a 10 or 13 item questionnaire that measures patients on a 0-100 scale and can segment patients into one of four activation levels along an empirically derived continuum. Each activation level reveals insight into an array of health-related characteristics, including attitudes, motivators, behaviors, and outcomes. A higher score indicates a better outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 weeks, 3 months |
|
|
|
| Other Pre-specified | Self-Evaluation of Breathing Questionnaire (SEBQ) Score | The SEBQ contains 12 items and assesses the patient's perception of their breathing difficulties and gives an insight into the effort of breathing and the feeling of air hunger. Responses to these items are on a 4-point Likert scale: (0) never/not true at all; (1) occasionally/a bit true; (2) frequently-mostly true; and, (3) very frequently/very true. SEBQ scores for sum of the original items ranged from 0 to 36, with a lower total indicating a better outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 weeks, 3 months |
|
|
|
| 0 |
| 42 |
| 5 |
| 42 |
| 11 |
| 42 |
|
| Hospitalization due to Missed Hemodialysis | Renal and urinary disorders | Systematic Assessment |
|
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | 2 hospitalizations due to pulmonary edema. |
|
| COVID-19 Infection | Infections and infestations | Systematic Assessment | 2 hospitalizations due to COVID-19 infection. |
|
| Anxiety | Social circumstances | Systematic Assessment | Anxiety was related to pending eviction from apartment. |
|
| COPD Requiring Modified Treatment | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Increased antibiotic and steroid use for COPD symptom management |
|
| UTI | Infections and infestations | Systematic Assessment | UTI requiring antibiotic treatment |
|
| Sleepiness | General disorders | Systematic Assessment |
|
| Fall (outdoors) | General disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D001523 | Mental Disorders |
| 3 months |
|
| DMQ-Anxiety |
|
| DMQ-Anxiety |
|
| 3 months |
|
| 3 months |
|
| PROMIS Physical |
|
| PROMIS Sleep Disturbance |
|
| PROMIS Physical |
|
| PROMIS Sleep Disturbance |
|
| 3 months |
|
| 3 months |
|
| 3 months |
|