Home Rehabilitation After Acute Pulmonary Embolism

Study Overview
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Brief Summary
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The purpose of this study is to evaluate whether a home rehabilitation program after hospitalization for acute pulmonary embolism (PE) improves clinical outcomes at 3 months compared to usual care. Daily physical activity tasks that incorporate heart rate monitoring will be sent through email or text. This information could help improve the management of acute PE.

Official Title
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Home Rehabilitation After Acute Pulmonary Embolism

Conditions
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Pulmonary Embolism

Intervention / Treatment
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* Behavioral: Daily Activity Text
* Behavioral: Control Text


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English speaking (>18 years old). Daily messages will be sent in English. Acute PE with right ventricular enlargement or dysfunction defined by echocardiogram report, CT Angiogram report, or elevated cardiac biomarker (NT-pro BNP or troponin). Baseline testing started within 7 days of hospital discharge. Exclusion Criteria: Pregnancy. Cardiac Effort >2.5 beats/m during 6MWT. This is for safety. Cardiac Effort <1.2 beats/m during 6MWT. They are unlikely to benefit. Resting tachycardia >120 beats/m during screening or at hospital discharge. Suspicion for Chronic Thromboembolic Pulmonary Hypertension. Systolic blood pressure >180 mmHg during screening or at hospital discharge. Inability to walk. Estimated prognosis <12 months at the time of discharge due to underlying co-morbidities. Advanced neurologic disease. Lack of access to email or text messaging. Inability to follow daily instructions. Participation in a structured exercise routine at least three days per week in the prior four weeks. Principal Investigator discretion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants who receive daily activity message<br>The intervention group will receive instructions for a daily activity sent through SMS text message or email. | Behavioral: Daily Activity Text<br>* Participants will receive a text each day with instructions about the daily activity they should complete for that day.<br>|
| Placebo Comparator: Participants who receive control message<br>The control group will receive daily messages to help with blinding sent through text message or email. The messages will not include activity tasks and will include phrases such as I hope you have a good day. | Behavioral: Control Text<br>* Participants will receive a text each day with no instructions about daily activity. It will have messages like have a nice day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean change in vector magnitude count as measured by actigraphy | The Actigraph triaxial accelerometer will be used to monitor continuous activity at home on the non-dominant wrist. The accelerometer data will be downloaded and will include the vector magnitude count. | 10 weeks | 
| mean change in mean amplitude deviation as measured by actigraphy | The Actigraph triaxial accelerometer will be used to monitor continuous activity at home on the non-dominant wrist. The accelerometer data will be downloaded and will include the mean amplitude deviation. | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of participants with post-PE syndrome | Participants will be evaluated by a physician to determine if they have post PE-syndrome | 12 weeks | 
| mean change in steps as measured by Actigraph | The Actigraph triaxial accelerometer will be used to monitor the number of steps taken at home on the non-dominant wrist. The accelerometer data will be downloaded and will include the step count. | 12 weeks | 
| 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. | 12 weeks | 
| mean change in quality of life as measured by PROMIS | The PROMIS questionnaire ranges from 0-99 with higher scores indicating worse outcome. | 12 weeks | 
| mean change in quality of life as measured by Emphasis 10 | The Emphasis 10 questionnaire ranges from 0-50 with higher scores indicating worse quality of life. | 12 weeks | 
| mean change in quality of life as measured by Pulmonary Embolism quality of life questionnaire | The pulmonary embolism quality of life questionnaire ranges from 1 to 27 with higher scores indicating worse outcomes. | 12 weeks | 
| mean change in 6 minute walking distance |  | 12 weeks | 
| mean change in heart rate during a 6 minute walk |  | 12 weeks | 
| mean change in oxygen use during a 6 minute walk | Oxygen use will be measured by a measured by portable K5 metabolic analyzer. | 12 weeks | 
| mean change in carbon dioxide production during a 6 minute walk | Carbon Dioxide use will be measured by a measured by portable K5 metabolic analyzer. | 12 weeks | 
| proportion or subjects who develop chronic thromboembolic pulmonary hypertension |  | 12 weeks |