search
Back to results

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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video Telehealth Pulmonary Rehabilitation
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease, COPD, Pulmonary Rehabilitation, Telehealth

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • Northwestern Memorial HospitalRecruiting
  • University of IowaRecruiting
  • Johns Hopkins UniversityRecruiting
  • University of MarylandRecruiting
  • Boston VA HospitalRecruiting
  • Minnesota VA HealthCare SystemRecruiting
  • Cincinnati VA HospitalRecruiting
  • Cleveland ClinicRecruiting
  • Temple University HospitalRecruiting
  • University of PittsburghRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Standard of Care

Video Telehealth Pulmonary Rehabilitation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
Cost Savings
Cost saving will be estimated by comparing costs of the intervention and savings resulting from readmission reduction within 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.

Secondary Outcome Measures

90-days all cause readmission rate
Hospitalizations will be ascertained by healthcare utilization questionnaire at the weekly phone calls.
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)
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
October 26, 2021
Last Updated
August 9, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
search

1. Study Identification

Unique Protocol Identification Number
NCT05119556
Brief Title
Video Telehealth Pulmonary Rehabilitation to Reduce Hospital Readmission in Chronic Obstructive Pulmonary Disease
Official Title
Video Telehealth Pulmonary Rehabilitation to Reduce Hospital Readmission in Chronic Obstructive Pulmonary Disease (Tele-COPD)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2022 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic Obstructive Pulmonary Disease, COPD, Pulmonary Rehabilitation, Telehealth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a 52 week, prospective, randomized controlled, phase 3, multi-center clinical trial.
Masking
Outcomes Assessor
Masking Description
A blinded adjudication committee will evaluate all hospitalizations.
Allocation
Randomized
Enrollment
768 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Video Telehealth Pulmonary Rehabilitation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Video Telehealth Pulmonary Rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
All-cause hospitalization within 30 days post discharge for an index admission for COPD exacerbation
Description
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.
Time Frame
30 days
Title
Change in St. George's Respiratory Questionnaire
Description
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.
Time Frame
13 weeks
Title
Change in six-minute walk distance
Description
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.
Time Frame
13 weeks
Title
Change in the University of California, San Diego Shortness of Breath Questionnaire
Description
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.
Time Frame
13 weeks
Title
Cost Savings
Description
Cost saving will be estimated by comparing costs of the intervention and savings resulting from readmission reduction within 30 days.
Time Frame
30 days
Title
Cost per Quality Adjusted Life Year Gained
Description
Cost-effectiveness will be calculated by comparing Telehealth PR with Standard of Care using incremental cost-effectiveness ratios.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
90-days all cause readmission rate
Description
Hospitalizations will be ascertained by healthcare utilization questionnaire at the weekly phone calls.
Time Frame
13 weeks
Title
The adverse events (AEs) and serious adverse events (SAEs)
Description
Safety of video telehealth PR intervention as determined by adverse events (AEs) and serious adverse events (SAEs)
Time Frame
13 weeks
Title
Change in COPD Assessment Test score
Description
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.
Time Frame
13 weeks
Title
Change in 30-second Sit-to-Stand Test
Description
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.
Time Frame
13 weeks
Title
Change in the Clinical visit-PROactive Physical Activity Score
Description
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.
Time Frame
13 weeks
Title
Change in Pulmonary Rehabilitation Adapted Index of Self-Efficacy
Description
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.
Time Frame
13 weeks
Title
Change in Pittsburgh Sleep Quality Index
Description
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.
Time Frame
13 weeks
Title
Change in Hospital Anxiety and Depression Scale
Description
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.
Time Frame
13 weeks
Title
Change in The modified Medical Research Council score
Description
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.
Time Frame
13 weeks
Other Pre-specified Outcome Measures:
Title
12-month all-cause hospitalizations
Description
Hospitalizations following the index admission will be ascertained by healthcare utilization questionnaire at the weekly and monthly phone calls.
Time Frame
52 weeks
Title
Change in COPD Assessment Test score
Description
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.
Time Frame
52 weeks
Title
Change in 30-second Sit-to-Stand Test
Description
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.
Time Frame
52 weeks
Title
Change in Clinical visit-PROactive Physical Activity Score
Description
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.
Time Frame
52 weeks
Title
Change in Pulmonary Rehabilitation Adapted Index of Self-Efficacy
Description
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.
Time Frame
52 weeks
Title
Change in Pittsburgh Sleep Quality Index
Description
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.
Time Frame
52 weeks
Title
Change in Hospital Anxiety and Depression Scale
Description
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.
Time Frame
52 weeks
Title
Change in The modified Medical Research Council score
Description
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.
Time Frame
52 weeks
Title
Change in St. George's Respiratory Questionnaire
Description
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.
Time Frame
52 weeks
Title
Change in six-minute walk distance
Description
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.
Time Frame
52 weeks
Title
Change in University of California, San Diego Shortness of Breath Questionnaire score
Description
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.
Time Frame
52 weeks
Title
All-cause mortality
Description
Any mortality will be recorded for the 52 weeks after index hospitalization.
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Surya P Bhatt, MD, MSPH
Phone
205-934-5555
Email
sbhatt@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Miki Jinno
Phone
205-996-1548
Email
mjinno@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Surya P Bhatt, MD, MSPH
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Surya P Bhatt, MD
Email
sbhatt@uabmc.edu
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ravi Kalhan, MD
Email
RKalhan@nm.org
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandro Comellas, MD
Email
alejandro-comellas@uiowa.edu
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nirupama Putcha, MD
Email
nputcha1@jhmi.edu
Facility Name
University of Maryland
City
College Park
State/Province
Maryland
ZIP/Postal Code
20742
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Reed, MD
Email
rreed@som.umaryland.edu
Facility Name
Boston VA Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marilyn Moy, MD
Email
Marilyn.Moy@va.gov
Facility Name
Minnesota VA HealthCare System
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ken Kunisaki, MD
Email
kunis001@umn.edu
Facility Name
Cincinnati VA Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Burkes, MD
Email
burkesrt@ucmail.uc.edu
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Umur Hatipoglu, MD
Email
HATIPOU@ccf.org
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerard Criner, MD
Email
Gerard.Criner@tuhs.temple.edu
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Bon, MD
Email
bonjm@upmc.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data will be shared through a password-protected website maintained without cost to researchers after requests are vetted by the principal investigators at UAB. The investigators will make the data and associated documentation available to users under a data sharing agreement that accounts for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Users must also agree to the conditions of use governing access to the public release of data, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource. Research data will be de-identified to prevent disclosure of personal identifiers and presented in a summary format.
IPD Sharing Time Frame
Data will be available 12 months after study completion.
IPD Sharing Access Criteria
With approval from the Publications and Presentations Committee

Learn more about this trial

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

We'll reach out to this number within 24 hrs