Video Telehealth Pulmonary Rehabilitation to Reduce Hospital Readmission in Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy and safety of a real time video telehealth pulmonary rehabilitation intervention with standard of care in patients hospitalized for an exacerbation of chronic obstructive pulmonary disease (COPD) to determine the impact on hospital readmissions and respiratory morbidity, and to investigate the cost-effectiveness of the intervention.

Detailed Description
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This is a 52 week, prospective, randomized controlled, phase 3, multi-center clinical trial (n=768 at 10 clinical sites) comparing the efficacy and safety of a real time video telehealth pulmonary rehabilitation intervention with standard of care in patients hospitalized for COPD exacerbation to determine the impact on hospital readmissions and respiratory morbidity, and to investigate the cost-effectiveness of the intervention. All patients with a clinical diagnosis of COPD who are hospitalized for an acute exacerbation of COPD at each clinical site will be considered for inclusion. Interested participants will be seen at 8 (-3 to +4) days after discharge from the hospital. At this visit, participants will be randomized 1:1, in varying blocks, stratified by site, to video telehealth PR plus standard of care versus standard of care alone. The telehealth intervention will involve 3 exercise sessions a week for 12 weeks. Exercise sessions will be provided in real-time via live two-way videoconferencing using a HIPAA-compliant app on an encrypted smart phone or similar device. Each session will be standardized to include cardiovascular (aerobic) training, strength (resistance) training, breathing exercises, and education that includes smoking cessation counselling where applicable, inhaler use techniques, diet, and nutrition. Participants in both the intervention and control arms will receive standard of care per local guidance. During the period of active intervention, participants in both arms will be contacted monthly to ascertain any exacerbations. Questionnaires and assessments of function will be administered at the baseline 7 day visit and at completion of the intervention at 13 weeks. Subsequently, participants in both arms will be called 3-monthly to ascertain healthcare utilization, and questionnaires and assessments of function will be repeated at the end of the follow-up period at 52 weeks.

Official Title
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Video Telehealth Pulmonary Rehabilitation to Reduce Hospital Readmission in Chronic Obstructive Pulmonary Disease (Tele-COPD)

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Behavioral: Video Telehealth Pulmonary Rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 40 to 85 years Clinical diagnosis of COPD Hospitalized for acute exacerbation of COPD. Be willing to adhere to trial and follow-up procedures and give informed consent Exclusion Criteria: Secondary diagnosis of congestive heart failure that is severe as documented by active symptoms, New York Heart Association (NYHA) functional classification IV or left ventricular ejection fraction <25% on echocardiography Other respiratory conditions that could confound the diagnosis such as asthma, pulmonary fibrosis, bronchiectasis, and lung cancer. Participants with pneumonic exacerbations of COPD will be included. Primary diagnosis of COVID pneumonia. Individuals with incidentally detected COVID or persistently positive for COVID but deemed to be convalescent will not be excluded. Active cancers on chemotherapy or radiation therapy Immunosuppressed states predisposing to frequent hospitalizations including uncontrolled HIV/AIDS Active or recent (within 1 month) myocardial infarction Angina not well-controlled by medication Unstable cardiac arrhythmias, atrial or ventricular Supplemental oxygen requirement greater than 5 liters per minute at either rest or with exertion Significant cognitive dysfunction, including dementia, that in opinion of investigator would impair ability to safely or effectively engage in study protocol Participants with any terminal medical illnesses as diagnosed by a physician, and/or on hospice Currently enrolled in and participating in pulmonary rehabilitation Dialysis therapy Treatment with invasive mechanical ventilation in-hospital or chronic home ventilatory support. Those on in-patient short-term non-invasive ventilation will not be excluded. Special patient groups such as prisoners and institutionalized patients Participants with musculoskeletal comorbidities or physical infirmities that preclude participation in an exercise program Current participation in any other interventional clinical trial Inability to understand and speak English during exercise sessions Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a 52 week, prospective, randomized controlled, phase 3, multi-center clinical trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>Participants will receive standard of care for COPD management per local guidance. In addition, they will receive 4-weekly phone calls for 13 weeks post discharge to inquire about health status and exacerbations. | |
| Active Comparator: Video Telehealth Pulmonary Rehabilitation<br>In addition to standard of care, participants will be asked to participate in rehabilitation sessions administered at home via live videoconferencing for approximately 60 minutes a session, three times a week. A total of 36 sessions will be planned to be completed by week 13 post-discharge. Exacerbations and health status will be ascertained every 4-weeks for 13 weeks. | Behavioral: Video Telehealth Pulmonary Rehabilitation<br>* Participant will be asked to exercise 3 times a week at their home for 60 minutes each session, via live two-way videoconferencing using a data-enabled smart phone or similar device. A total of 36 sessions will be administered over 13 weeks post-discharge. Sessions will be administered by exercise physiologists located at the University of Alabama at Birmingham. Each session will be scheduled with up to three other participants at a time to mimic group sessions as delivered at center-based pulmonary rehabilitation programs. Exercise sessions will include aerobics, strength or resistance training, breathing exercises, and education sessions. The exercise plans will be tailored according to the participants' baseline exercise tolerance as determined by an initial six minute walk test and their answers to the questionnaires at the baseline visit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause hospitalization within 30 days post discharge for an index admission for COPD exacerbation | Hospitalizations will be ascertained via weekly phone calls. Hospitalization for any reason will be considered a primary event when it occurs within the first 30 days after index hospitalization. | 30 days | 
| Change in St. George's Respiratory Questionnaire | The St. George's Respiratory Questionnaire (SGRQ) is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. It consists of 40 questions, and scores range from 0 to 100, with higher scores indicating worse quality of life. The minimum clinically important difference (MCID) is 4 units. | 13 weeks | 
| Change in six-minute walk distance | The six-minute walk test is an assessment of functional capacity, and is the distance walked in 6 minutes. The minimum clinically important difference (MCID) for COPD is 26 m. | 13 weeks | 
| Change in the University of California, San Diego Shortness of Breath Questionnaire | The University of California, San Diego Shortness of Breath Questionnaire (SOBQ) is a 24-question, self-administered questionnaire which rates dyspnea associated with activities of daily living. Scores range from 0 to 120, with higher scores indicating greater dyspnea. The minimum clinically important difference (MCID) is 5. | 13 weeks | 
| Cost Savings | Cost saving will be estimated by comparing costs of the intervention and savings resulting from readmission reduction within 30 days. | 30 days | 
| Cost per Quality Adjusted Life Year Gained | Cost-effectiveness will be calculated by comparing Telehealth PR with Standard of Care using incremental cost-effectiveness ratios. | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90-days all cause readmission rate | Hospitalizations will be ascertained by healthcare utilization questionnaire at the weekly phone calls. | 13 weeks | 
| The adverse events (AEs) and serious adverse events (SAEs) | Safety of video telehealth PR intervention as determined by adverse events (AEs) and serious adverse events (SAEs) | 13 weeks | 
| Change in COPD Assessment Test score | The COPD Assessment Test (CAT) survey is a validated, short (8-item) and simple patient completed questionnaire, and measures the health status of patients with COPD. This score is responsive to interventions such as pulmonary rehabilitation with a minimum clinically important difference (MCID) of 2 units. | 13 weeks | 
| Change in 30-second Sit-to-Stand Test | The 30-second Sit-to-Stand test is an assessment of skeletal muscle dysfunction, leg strength and endurance. Scores range from 4 to 14, depending on age and sex, and higher scores indicate higher levels of functioning. The minimum clinically important difference (MCID) is 2. | 13 weeks | 
| Change in the Clinical visit-PROactive Physical Activity Score | The Clinical visit-PROactive Physical Activity in COPD (C-PPAC) questionnaire will be used to generate scores for amount of physical activity, difficulty with physical activity and total physical activity experience. C-PPAC scores will be calculated by combining questionnaire items with two variables from activity monitors (steps/day and vector magnitude units (VMU)/min). Scores range from 0 to 100, where higher numbers indicate a better score. The minimum clinically important difference (MCID) is 6 for the amount and difficulty scores and 4 for the total score. | 13 weeks | 
| Change in Pulmonary Rehabilitation Adapted Index of Self-Efficacy | The Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) tool is a 15-item disease-specific questionnaire that measures pulmonary rehabilitation-specific self-efficacy. The score ranges from 15 to 60, with higher scores indicating high levels of self-efficacy. The minimum clinically important difference (MCID) is 1.5 units. | 13 weeks | 
| Change in Pittsburgh Sleep Quality Index | The Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality over a 1-month time interval. It has 7 components (sleep quality, latency, duration, efficiency, disturbance, medication use, and daytime dysfunction) that are each scored from 0 to 3 for a total PSQI score of 0 to 21, with higher scores indicating worse sleep quality. The minimum clinically important difference (MCID) is 3 units. | 13 weeks | 
| Change in Hospital Anxiety and Depression Scale | The Hospital Anxiety and Depression Scale (HADS) will be used to measure symptoms of anxiety and depression. The HADS contains 14 items and consists of two subscales: anxiety and depression. Each item is rated on a four-point scale, with maximum scores of 21 for anxiety and depression. The minimum clinically important difference (MCID) is 1.5 units. | 13 weeks | 
| Change in The modified Medical Research Council score | The modified Medical Research Council (mMRC) has 5 questions that assess dyspnea in a graded fashion and quantify symptoms in COPD. The minimum clinically important difference (MCID) is 0.7. | 13 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Pulmonary Disease, COPD, Pulmonary Rehabilitation, Telehealth