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Telehealth Pulmonary Rehabilitation for COPD
N/A
Recruiting
Led By Surya P Bhatt, MD, MSPH
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hospitalized for acute exacerbation of COPD.
Clinical diagnosis of COPD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights
Study Summary
This trial will compare the effects of a real-time video telehealth intervention for pulmonary rehabilitation vs. standard care for COPD patients hospitalized for an exacerbation. The study will look at readmission rates and respiratory morbidity, as well as the cost-effectiveness of the intervention.
Who is the study for?
This trial is for adults aged 40-85 hospitalized with a flare-up of COPD, willing to follow the study plan and give consent. Excluded are those with terminal illnesses, severe heart failure, cognitive issues preventing safe participation, non-English speakers, certain immunosuppressed states or active cancers, recent heart attacks or on invasive ventilation.Check my eligibility
What is being tested?
The study tests if video telehealth pulmonary rehabilitation can reduce hospital readmissions in COPD patients compared to standard care. It will assess effectiveness and safety of this method and its cost-effectiveness.See study design
What are the potential side effects?
Since the intervention involves exercise through video telehealth rather than medication, side effects may include typical risks associated with physical activity such as muscle strain or fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am in the hospital for a severe COPD flare-up.
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I have been diagnosed with COPD.
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I am between 40 and 85 years old.
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I am in the hospital for a sudden worsening of my COPD.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
All-cause hospitalization within 30 days post discharge for an index admission for COPD exacerbation
Change in the University of California, San Diego Shortness of Breath Questionnaire
Cost Savings
+1 moreSecondary outcome measures
90-days all cause readmission rate
Change in the Clinical visit-PROactive Physical Activity Score
The adverse events (AEs) and serious adverse events (SAEs)
Other outcome measures
12-month all-cause hospitalizations
All-cause mortality
Change in 30-second Sit-to-Stand Test
+9 moreTrial Design
2Treatment groups
Active Control
Group I: Standard of CareActive Control1 Intervention
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.
Group II: Video Telehealth Pulmonary RehabilitationActive Control1 Intervention
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.
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,280,714 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,837 Previous Clinical Trials
47,850,826 Total Patients Enrolled
Surya P Bhatt, MD, MSPHPrincipal InvestigatorUniversity of Alabama at Birmingham
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a terminal illness and/or am receiving hospice care.I am in the hospital for a severe COPD flare-up.I have severe heart failure with significant symptoms or very poor heart pump function.I have been diagnosed with COPD.I am currently receiving chemotherapy or radiation for my cancer.I have been primarily diagnosed with COVID pneumonia.I have COPD but no other major lung conditions like asthma or lung cancer.I have a condition like uncontrolled HIV that often requires hospital stays.My chest pain is not well-managed with medication.I am or have been on a ventilator for breathing support.I am between 40 and 85 years old.I cannot understand or speak English during exercise sessions.I am currently in a lung rehab program.I am on dialysis therapy.I do not have irregular heartbeats that are severe or uncontrolled.I have had a heart attack in the last month.I cannot join an exercise program due to physical health issues.People who are in prison or living in an institution.I need more than 5 liters of oxygen per minute, whether I'm resting or moving.I am in the hospital for a sudden worsening of my COPD.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care
- Group 2: Video Telehealth Pulmonary Rehabilitation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Chronic Obstructive Pulmonary Disease Patient Testimony for trial: Trial Name: NCT05119556 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many medical institutions are administering this experiment?
"This research is taking place in various locations, like Boston VA Hospital in Massachusetts, University of Maryland College Park and Temple University Hospital located in Pennsylvania to name but a few."
Answered by AI
How many people can potentially be part of this trial at maximum capacity?
"Affirmative. According to the information found on clinicaltrials.gov, this study is recruiting participants and it was originally posted on June 28th 2022 with its last update occuring on August 11th 2022. A total of 768 individuals across 9 medical centres are necessary for successful completion of this trial."
Answered by AI
Is the minimum age requirement for participation in this experiment 18 years or older?
"All potential participants need to be between the ages of 40 and 85 in order to qualify for this trial."
Answered by AI
Are there any openings remaining in this trial for participants?
"Affirmative, the clinicaltrials.gov records demonstrate that recruitment for this medical experiment is ongoing. It was first listed on June 28th 2022 and recently updated on August 11th 2022. Aspiring participants can apply at any of the 9 locations; a total of 768 volunteers are required."
Answered by AI
Does this research project have any vacancies available for participants?
"This experiment requires 768 participants of the ages 40 to 85 with a diagnosis of chronic obstructive pulmonary disease who have been recently hospitalized for an acute exacerbation. Furthermore, those interested must be prepared to adhere to trial and follow-up protocols in addition to providing informed consent."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Mississippi
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Minnesota VA HealthCare System
University of Alabama at Birmingham
How many prior treatments have patients received?
2
Why did patients apply to this trial?
To see what I can do to help future patients with COPD.
PatientReceived 2+ prior treatments
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