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Enabling Independent Living by Expanding Access to Home-Based Pulmonary Rehabilitation

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video Chat
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

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

Inclusion Criteria:

  • Patients must be ≥ 40 years old.
  • Patients mist have a diagnosis of GOLD stage II, III, or IV COPD documented by pulmonary function testing.
  • Patients must be a current or previous smoker with at least 10 pack-years of cigarette smoking.

Additional Inclusion Criteria to test Spanish version of system:

  • Be a native Spanish speaker.

Exclusion Criteria:

  • Patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency).
  • Patients planning to move out of the state or who are not living in the healthcare area.
  • Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition).

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intervention

Arm Description

This is a small study to assess the usability of video conferencing. A total of 10 patients will be enrolled, 5 of which will be Spanish speakers. All patients will test the video conferencing.

Outcomes

Primary Outcome Measures

Qualitative Interview
A Qualitative Interview will be conducted over the phone asking about the video chat experience.

Secondary Outcome Measures

Full Information

First Posted
July 17, 2020
Last Updated
July 7, 2022
Sponsor
Mayo Clinic
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT04479969
Brief Title
Enabling Independent Living by Expanding Access to Home-Based Pulmonary Rehabilitation
Official Title
Enabling Independent Living by Expanding Access to Home-Based Pulmonary Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 22, 2021 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
July 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
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
No

5. Study Description

Brief Summary
The purpose of this study is to test an existing home-based pulmonary rehab program with the addition of video chat and a capability of a Spanish version.
Detailed Description
The purpose of this research is to test video chat on a computer tablet that is used for Pulmonary Rehabilitation. We are interested in learning patients' thoughts on how easy or difficult video chat is to use and the translation to Spanish and the feed back from Spanish speaking patients .

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Other
Arm Description
This is a small study to assess the usability of video conferencing. A total of 10 patients will be enrolled, 5 of which will be Spanish speakers. All patients will test the video conferencing.
Intervention Type
Behavioral
Intervention Name(s)
Video Chat
Intervention Description
Video chat with health coach using a computer tablet.
Primary Outcome Measure Information:
Title
Qualitative Interview
Description
A Qualitative Interview will be conducted over the phone asking about the video chat experience.
Time Frame
Week 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must be ≥ 40 years old. Patients mist have a diagnosis of GOLD stage II, III, or IV COPD documented by pulmonary function testing. Patients must be a current or previous smoker with at least 10 pack-years of cigarette smoking. Additional Inclusion Criteria to test Spanish version of system: Be a native Spanish speaker. Exclusion Criteria: Patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency). Patients planning to move out of the state or who are not living in the healthcare area. Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto P Benzo
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Enabling Independent Living by Expanding Access to Home-Based Pulmonary Rehabilitation

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