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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05119556
• Other study ID #: IRB-300008210
• Secondary ID: 1UG3HL155806-01A
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2022
• Est. completion date: August 31, 2027

Study information

• Verified date: February 2024
• Source: University of Alabama at Birmingham
• Contact: Surya P Bhatt, MD, MSPH
• Phone: 205-934-5555
• Email: sbhatt[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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 8 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 768
• Est. completion date: August 31, 2027
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Age 40 to 85 years

2. Clinical diagnosis of COPD

3. Hospitalized for acute exacerbation of COPD.

4. Be willing to adhere to trial and follow-up procedures and give informed consent

Exclusion Criteria:

1. 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

2. 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.

3. Primary diagnosis of COVID pneumonia. Individuals with incidentally detected COVID or persistently positive for COVID but deemed to be convalescent will not be excluded.

4. Active cancers on chemotherapy or radiation therapy

5. Immunosuppressed states predisposing to frequent hospitalizations including uncontrolled HIV/AIDS

6. Active or recent (within 1 month) myocardial infarction

7. Angina not well-controlled by medication

8. Unstable cardiac arrhythmias, atrial or ventricular

9. Supplemental oxygen requirement greater than 5 liters per minute at either rest or with exertion

10. Significant cognitive dysfunction, including dementia, that in opinion of investigator would impair ability to safely or effectively engage in study protocol

11. Participants with any terminal medical illnesses as diagnosed by a physician, and/or on hospice

12. Currently enrolled in and participating in pulmonary rehabilitation

13. Dialysis therapy

14. 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.

15. Special patient groups such as prisoners and institutionalized patients

16. Participants with musculoskeletal comorbidities or physical infirmities that preclude participation in an exercise program

17. Current participation in any other interventional clinical trial

18. Inability to understand and speak English during exercise sessions

19. Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Video Telehealth Pulmonary Rehabilitation
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.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	HealthPartners Institute	Bloomington	Minnesota
United States	Boston VA Hospital	Boston	Massachusetts
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Cincinnati VA Hospital	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Maryland	College Park	Maryland
United States	Baylor College of Medicine	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	Minnesota VA HealthCare System	Minneapolis	Minnesota
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	12-month all-cause hospitalizations	Hospitalizations following the index admission will be ascertained by healthcare utilization questionnaire at the weekly and monthly phone calls.	52 weeks
Other	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.	52 weeks
Other	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.	52 weeks
Other	Change in 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.	52 weeks
Other	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.	52 weeks
Other	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.	52 weeks
Other	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.	52 weeks
Other	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.	52 weeks
Other	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.	52 weeks
Other	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.	52 weeks
Other	Change in University of California, San Diego Shortness of Breath Questionnaire score	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.	52 weeks
Other	All-cause mortality	Any mortality will be recorded for the 52 weeks after index hospitalization.	52 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Cost Savings	Cost saving will be estimated by comparing costs of the intervention and savings resulting from readmission reduction within 30 days.	30 days
Primary	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	90-days all cause readmission rate	Hospitalizations will be ascertained by healthcare utilization questionnaire at the weekly phone calls.	13 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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