Chronic Obstructive Pulmonary DiseaseNCT04479969
Enabling Independent Living by Expanding Access to Home-Based Pulmonary Rehabilitation
A study testing Video Chat in people with Chronic Obstructive Pulmonary Disease, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Video Chat
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2021to 30 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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.
Read the 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 .
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Video Chat
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video ChatBehavioural
Video chat with health coach using a computer tablet.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | 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. Receives: Behavioral: Video Chat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative Interview
A Qualitative Interview will be conducted over the phone asking about the video chat experience.
Measured: Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start22 Mar 2021
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Roberto P. Benzo, Mayo Clinic
- Investigators
- Roberto P Benzo, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04479969
- Sponsor's protocol ID
- 20-003806
- Other IDs
- 1R43HL151461
- Status last verified
- Jul 2022
- First submitted
- 17 Jul 2020
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enabling Independent Living by Expanding Access to Home-Based Pulmonary Rehabilitation
- ClinicalTrials.gov ID
- NCT04479969
- Acronym / sponsor ID
- 20-003806
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Behavioral: Video ChatThis 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Be a native Spanish speaker.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video ChatVideo chat with health coach using a computer tablet. | Behavioural | Intervention |
Primary outcome
Qualitative Interview
Time frame: Week 1
A Qualitative Interview will be conducted over the phone asking about the video chat experience.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto P Benzo principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Chat in people with Chronic Obstructive Pulmonary Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative Interview (time frame: Week 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2022.