- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04479969
Enabling Independent Living by Expanding Access to Home-Based Pulmonary Rehabilitation
July 7, 2022 updated by: Roberto P. Benzo, Mayo Clinic
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 .
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Intervention
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.
|
Video chat with health coach using a computer tablet.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Qualitative Interview
Time Frame: Week 1
|
A Qualitative Interview will be conducted over the phone asking about the video chat experience.
|
Week 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 22, 2021
Primary Completion (Actual)
July 30, 2021
Study Completion (Actual)
July 30, 2021
Study Registration Dates
First Submitted
July 17, 2020
First Submitted That Met QC Criteria
July 17, 2020
First Posted (Actual)
July 21, 2020
Study Record Updates
Last Update Posted (Actual)
July 8, 2022
Last Update Submitted That Met QC Criteria
July 7, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-003806
- 1R43HL151461 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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