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| Name | Class |
|---|---|
| COPD Foundation | OTHER |
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The clinical objectives of this study are to determine whether utilization of the Wellinks COPD Solution can improve quality of life for patients with COPD, can reduce healthcare resource utilization over time, and can improve pulmonary function as measured by connected devices.
The nonclinical objectives of this study are to describe the experience of patients using the Wellinks Solution through the assessment of patient engagement with the solution, as well as by patient-reported satisfaction with the solution and their perceived value (e.g., willingness to pay). Qualitative feedback on the features and functionality of the Wellinks Solution will be solicited.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Arm 1: Subjects will receive 24 weeks of access to the Wellinks Solution. |
|
| Arm 2 | Experimental | Arm 1: Subjects will receive 24 weeks of access to the Wellinks Solution. The latter 12 weeks will be entirely asynchronous. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wellinks | Other | Digital health and virtual care program for COPD management. |
|
| Measure | Description | Time Frame |
|---|---|---|
| COPD Symptoms Assessment | Change in self-reported symptoms as collected in the app. | Change from baseline to 12 weeks |
| COPD Symptoms Assessment | Change in self-reported symptoms as collected in the app. | Change from baseline to 24 weeks |
| COPD Self-Efficacy Scale | Change in COPD Self-Efficacy Scale | Change from baseline to 12 weeks |
| COPD Self-Efficacy Scale | Change in COPD Self-Efficacy Scale | Change from baseline to 24 weeks |
| Patient-Reported Healthcare Resource Utilization (HRU) | Measure of health resource utilization from period baseline to 12 weeks. Emergency room visits. Hospitalizations. | 12 weeks |
| Patient-Reported Healthcare Resource Utilization (HRU) | Measure of health resource utilization from period 12 to 24 weeks. Emergency room visits. Hospitalizations. | 24 weeks |
| Modified Medical Research Council Dyspnea Scale (mMRC) | Change in mMRC score. (0-4, 0 is best) | Change from baseline to 12 weeks |
| Modified Medical Research Council Dyspnea Scale (mMRC) |
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| Measure | Description | Time Frame |
|---|---|---|
| Participant Net Promoter Score (nPS) | Measure of the Net Promoter Score - (How likely are you to recommend wellinks to a friend or family member?). Scale: -100 to +100, higher is better. | 24 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gretchen McCreary | COPD Foundation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wellinks | New Haven | Connecticut | 06511 | United States | ||
| COPD Foundation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38335023 | Derived | Pierz KA, Locantore N, McCreary G, Calvey RJ, Hackney N, Doshi P, Linnell J, Sundaramoorthy A, Reed CR, Yates J. Investigation of the Impact of Wellinks on the Quality of Life and Clinical Outcomes in Patients With Chronic Obstructive Pulmonary Disease: Interventional Research Study. JMIR Form Res. 2024 Feb 9;8:e47555. doi: 10.2196/47555. |
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Change in mMRC score. (0-4, 0 is best)
| Change from baseline to 24 weeks |
| Washington D.C. |
| District of Columbia |
| 20002 |
| United States |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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