N/A
N=42
Capnography-Assisted Learned Monitored (CALM) Breathing Therapy for COPD
COPD
Bottom Line
View on ClinicalTrials.gov: NCT04786184 ↗Enrolled (actual)
42
Serious AEs
11.9%
Results posted
Jul 2024
Primary outcome: Primary: Mean Attendance Rate of CALM Breathing Treatment Sessions — 84.2 percentage of completed sessions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CALM Breathing (Behavioral); Traditional outpatient PR (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Attendance Rate of CALM Breathing Treatment Sessions |
84.2 | — |
| PRIMARY Drop-Out Rate |
1 | — |
| PRIMARY CALM Breathing Satisfaction Rating |
2 | — |
| SECONDARY Chronic Respiratory Disease Questionnaire (CRQ) Score |
4.63; 4.06; 5.24; 4.19; 4.94; 4.31 | — |
| SECONDARY Dyspnea Management Questionnaire Computer Adaptive Test (DMQ-CAT) Score |
54.9; 54.0; 55.0; 53.0; 57; 52.7 | — |
| SECONDARY Dyspnea Management Questionnaire Computer Adaptive Test (DMQ-CAT) Score |
54.9; 54.0; 55.0; 53.0; 57; 52.7 | — |
| SECONDARY Modified Borg Scale Score |
3; 5; 2; 4 | — |
| SECONDARY Modified Borg Scale Score |
3; 5; 2; 4 | — |
| SECONDARY Generalized Anxiety Disorder-7 (GAD-7) Score |
— | — |
| SECONDARY Perceived Stress Scale Score (PSS) |
12; 18; 13; 21; 10; 19 | — |
| SECONDARY 6 Mile Walking Distance Score (6MWT) |
304; 341; 283; 319; 295; 369 | — |
| SECONDARY Physical Activity Scale for the Elderly (PASE) |
— | — |
| SECONDARY Change in COPD Assessment Test (CAT) Score |
1; 19; -6; 7 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS-24). |
52; 45; 52; 59; 39.4; 38 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS-24). |
52; 45; 52; 59; 39.4; 38 | — |
| SECONDARY End-tidal CO2 |
30; 32.5; 34; 31.1; 31; 29.8 | — |
| SECONDARY Patient Activation Measure (PAM) Score |
45; 43; 45; 42; 46; 44 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- be adult males or females
- have a diagnosis of COPD as defined by FEV1/FVC of 40)
- have hypercapnia of ETCO2 > 50 mmHg at rest
- have a musculoskeletal disorder severe enough to interfere with walking or ability to exercise or have neuromuscular disease
- have had a seizure in the past 3 months
- reside in an acute hospital, sub-acute care, assisted living, or nursing home
- are active smokers
- are pregnant
- have any clinically significant cardiac disease or any electrocardiogram (ECG) abnormality obtained during the screening, which in the opinion of the investigator may put the patient at risk or interfere with study assessments
- have low literacy as indicated by scores of 4 or 5 ("often" and "always") on the Single Item Literacy Screener (SILS) that asks, "How often do you need to have someone help you when you read instructions, pamphlets, or other written material from your doctor or pharmacy?"
- have a diagnosis or medical history of schizophrenia, psychotic disorders, or bipolar disorder as diagnosed by study psychologist
- have alcohol or substance abuse or dependence within the past 6 months as evaluated by study psychologist
- have serious suicidal risk (suicidal ideation or suicidal behaviors within the past year) as defined by a score of >1 on psychologist interview-administered Clinician Suicide Assessment Checklist, which is a Modified Columbia-Suicide Severity Rating Scale-CSSRS
- Take prescribed opioids ≥50 MME (morphine mg equivalents) per day. A dosage threshold of ≥50 MME significantly increases the risk of fatal respiratory depression and necessitates additional precautions. Participants' opioid medication dose will be confirmed by their prescribing physician (e.g., their primary care or pain management doctor).
- Actively take both prescribed opioids and benzodiazepines. Combining benzodiazepines and opioids significantly increases the risk of respiratory failure in patients with chronic obstructive pulmonary disease.
Data sourced from ClinicalTrials.gov (NCT04786184). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.