Incorporating Healthy Living Strategies to Aid in Recovery After Acute Pulmonary Embolism (ERASE-PE)

University of Rochester

Status: Enrolling

Conditions: Acute Pulmonary Embolism

Treatments: Behavioral: Healthy Living Intervention-2; Behavioral: Healthy Living Intervention-1

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06784492

STUDY00009895

1K23HL171867 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. English speaking (>18 years old). Daily messages will be sent in English.

2. Acute PE with at least one of the following:

   1. any right ventricular enlargement or dysfunction on echocardiogram;
   2. CT Angiogram reporting any right ventricular enlargement; or
   3. elevated cardiac biomarker (NT-pro BNP or troponin above baseline). Criteria for enrollment will be included on source document.

3. 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.

4. Subjects do need to take prescribed anticoagulation.

Exclusion criteria

1. Pregnancy.
2. Cardiac Effort >3.5 beats/m during 6MWT.
3. Resting tachycardia >110 beats/m at hospital discharge.
4. Chronic Thromboembolic Pulmonary Hypertension
5. Systolic blood pressure >180 mmHg at hospital discharge.
6. Inability to walk.
7. Estimated prognosis <12 months at the time of discharge due to underlying co-morbidities (e.g., cancer).
8. Advanced neurologic disease and would not be able to comply with the messages.
9. Lack of access to email or text messaging 10. Inability or unwillingness to follow daily instructions.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Healthy Living Intervention-1

Experimental group

Description:

Participants who receive daily messages about a healthy intervention.

Treatment:

Behavioral: Healthy Living Intervention-1

Healthy Living Intervention-2

Active Comparator group

Description:

Participants who receive daily messages about a different healthy intervention.

Treatment:

Behavioral: Healthy Living Intervention-2