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| ID | Type | Description | Link |
|---|---|---|---|
| 5R44HL147667-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Virginia | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The goal of this clinical trial is to test a device called "ROAM" that is being developed to see how patients with chronic obstructive pulmonary disease (COPD) use oxygen therapy over a long period of time. This study will focus on evaluating the ROAM device, which will be attached to your oxygen source. The question that the study aims to answer is: will patients who receive daily adherence feedback from the ROAM have increased adherence to their prescribed long term oxygen therapy regimens?
Researchers will compare the amount of time using oxygen and attitudes about oxygen therapy observed in a group that receives feedback from ROAM, and a control group that does not receive feedback.
Participants will have their oxygen supplies fitted with the ROAM device and then use their oxygen as usual for the 5-week study duration. Participants in the study group will have access to information about their oxygen usage and pulse oximetry levels. All participants will attend two in-clinic sessions of about an hour each, and will complete questionnaires at the beginning and end of the study.
This clinical trial will be a conventional randomized, parallel controlled trial to evaluate the primary hypothesis that a 4-week period of using the ROAM adherence monitor and support system will result in increased adherence when compared to a control group with no adherence monitoring. The participant population will be individuals with chronic obstructive pulmonary disease (COPD), and who have been prescribed oxygen therapy for a minimum of 8 hours/day. Half of the participants will be randomly assigned to the ROAM group; the other half will comprise the control group.
All participants will bring their regular oxygen supplies to the clinic to be fitted with the ROAM sensors. To establish baseline adherence, for the first week, all participants will be blinded to feedback from the ROAM system (including oxygen usage times and oxygen saturation levels); a special code will disable feedback on the local system, including the adherence displays and notifications. After one week, the oxygen usage times will be averaged, and used as a baseline of adherence.
Control participants will continue to be blinded to the ROAM feedback for the next four weeks. After the first week, the ROAM group participants will be instructed to enter a code to enable the ROAM user feedback display on the concentrator and portable tank systems. These participants will be instructed to take pulse oximetry readings as they usually do using the ROAM system's included oximeter. A minimum of two readings per day will be encouraged by built-in alerts on the system. They will continue using the system, while receiving feedback on daily adherence rates and oxygen saturation levels, for the 4-week study duration.
The average daily oxygen use times over the four-week study period will be computed, and use times for the ROAM group will be compared to those of the control group. At the beginning and end of the study, patients will complete a questionnaire to assess attitudes toward treatment. The primary outcome metric will be adherence rates (% adherent = actual treatment time/prescribed treatment time) of the oxygen therapy. The secondary outcome metric will be attitude towards treatment, as assessed via questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ROAM Group | Experimental | The ROAM group participants will have access to the ROAM user feedback display on their concentrator and portable tank oxygen delivery systems, throughout the 4-week study duration. |
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| Control Group | Sham Comparator | The control group participants will have their oxygen delivery concentrators and portable tanks fitted with the ROAM system, which will monitor their usage, but they will not receive any of the user feedback or have access to the ROAM software. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activated ROAM System with User Feedback | Device | The activated ROAM device will provide the user with daily information about their oxygen therapy usage and pulse oximetry. |
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| Measure | Description | Time Frame |
|---|---|---|
| Adherence rates of oxygen therapy | Adherence rates are computed as the participant's average daily actual treatment time divided by the prescribed daily treatment time. | From enrollment through completion of the study at 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Activation Model Scores | The Patient Activation Model (PAM) is an established, highly reliable, questionnaire that reflects a developmental model of patient engagement with their healthcare regimens. | at the study completion at 5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eileen Krepkovich, MS | Contact | 434-973-1215 | 123 | krepkovich@barron-associates.com |
| Name | Affiliation | Role |
|---|---|---|
| Eileen Krepkovich, MS | Barron Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Sham Comparator | Device | The sham comparator is a ROAM device that monitors oxygen usage, but keeps the usage details blind to the user. |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |