Video Telehealth Pulmonary Rehabilitation to Reduce Hospital Readmission in Chronic Obstructive Pulmonary Disease (Tele-COPD)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 301
- 试验地点
- 20
- 主要终点
- All-cause hospitalization within 30 days post discharge for an index admission for COPD exacerbation
研究概览
简要总结
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.
详细描述
This is a 52 week, prospective, randomized controlled, phase 3, multi-center clinical trial (n=768 at 14 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
A blinded adjudication committee will evaluate all hospitalizations.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 or greater
- •Clinical diagnosis of COPD
- •Hospitalized for acute exacerbation of COPD.
- •Be willing to adhere to trial and follow-up procedures and give informed consent
排除标准
- •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
- •Treatment with chronic or newly initiated 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
研究组 & 干预措施
Standard of Care
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.
Video Telehealth Pulmonary Rehabilitation
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.
干预措施: Video Telehealth Pulmonary Rehabilitation (Behavioral)
结局指标
主要结局
All-cause hospitalization within 30 days post discharge for an index admission for COPD exacerbation
时间窗: 30 days
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.
Change in six-minute walk distance
时间窗: 13 weeks
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.
Change in St. George's Respiratory Questionnaire
时间窗: 13 weeks
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.
Cost Savings
时间窗: 30 days
Cost saving will be estimated by comparing costs of the intervention and savings resulting from readmission reduction within 30 days.
Change in the University of California, San Diego Shortness of Breath Questionnaire
时间窗: 13 weeks
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.
Cost per Quality Adjusted Life Year Gained
时间窗: 52 weeks
Cost-effectiveness will be calculated by comparing Telehealth PR with Standard of Care using incremental cost-effectiveness ratios.
次要结局
- 90-days all cause readmission rate(13 weeks)
- The adverse events (AEs) and serious adverse events (SAEs)(13 weeks)
- Change in COPD Assessment Test score(13 weeks)
- Change in 30-second Sit-to-Stand Test(13 weeks)
- Change in Pittsburgh Sleep Quality Index(13 weeks)
- Change in the Clinical visit-PROactive Physical Activity Score(13 weeks)
- Change in Pulmonary Rehabilitation Adapted Index of Self-Efficacy(13 weeks)
- Change in Hospital Anxiety and Depression Scale(13 weeks)
- Change in The modified Medical Research Council score(13 weeks)
研究者
Surya P Bhatt
Professor of Medicine
University of Alabama at Birmingham