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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23HL171867 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The purpose of the ERAsE-PE study is to determine whether two different healthy living strategies (along with anticoagulation) might aid in recovery after a patient is hospitalized for pulmonary embolism. Specifically, Investigators will compare changes in Cardiac Effort (#heart beats used during the 6-minute walk test/walk distance) measured after an 8-week program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Living Intervention-1 | Experimental | Participants who receive daily messages about a healthy intervention. |
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| Healthy Living Intervention-2 | Active Comparator | Participants who receive daily messages about a different healthy intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy Living Intervention-1 | Behavioral | Participants will receive a text or email each day with instructions about a healthy intervention. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean change in cardiac effort | Change in cardiac effort is measured as the number of heart beats used during the 6-minute walk test. | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean number of health care visits (Health Care Utilization) | Subject medical records will be reviewed to determine the number of utilizations. | 3 months |
| Mean change in Pulmonary Embolism Quality of Life Questionnaire (PEQOL) Score |
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Inclusion Criteria:
English speaking (>18 years old). Daily messages will be sent in English.
Acute PE with at least one of the following:
Rate controlled atrial arrythmias (resting heart rate <110 beats/m) are eligible for enrollment. This includes atrial fibrillations. This is standard of care management for atrial fibrillation.
Subjects do need to take prescribed anticoagulation.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel J Lachant, DO | Contact | 5852769357 | daniel_lachant@urmc.rochester.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Recruiting | Rochester | New York | 14620 | United States |
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| Healthy Living Intervention-2 | Behavioral | Participants will receive a text or email each day with instructions about a healthy intervention. |
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The pulmonary embolism quality of life questionnaire ranges from 1 to 27, with higher scores indicating worse outcomes.
| baseline and 3 months |
| Mean change in 6 minute walk distance | baseline and 3 months |
| Mean change in activity as measured by Actigraph | The Actigraph triaxial accelerometer will be used to monitor the amount of activity taken at home on the non-dominant wrist. The accelerometer data will be downloaded and will include the amount of activity. | baseline and 3 months |
| mean change in diagnoses | Investifators will sum up the number of post-PE syndrome and CTEPH diagnoses and report the mean change in the sum between baseline and month 3. | baseline and month 3 |