Incorporating Healthy Living Strategies to Aid in Recovery After Acute Pulmonary Embolism

University of Rochester100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Acute Pulmonary Embolism

Interventions

Healthy Living Intervention-1BEHAVIORAL

Participants will receive a text or email each day with instructions about a healthy intervention.

Healthy Living Intervention-2BEHAVIORAL

Participants will receive a text or email each day with instructions about a healthy intervention.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Rochester Medical Center

Rochester, New York, United States

RECRUITING

Outcomes

Primary Outcomes

Mean change in cardiac effort

Change in cardiac effort is measured as the number of heart beats used during the 6-minute walk test.

Time frame: Baseline and 3 months

Secondary Outcomes

Mean number of health care visits (Health Care Utilization)

Subject medical records will be reviewed to determine the number of utilizations.

Time frame: 3 months

Mean change in Pulmonary Embolism Quality of Life Questionnaire (PEQOL) Score

The pulmonary embolism quality of life questionnaire ranges from 1 to 27, with higher scores indicating worse outcomes.

Time frame: baseline and 3 months

Mean change in 6 minute walk distance

Time frame: 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.

Time frame: 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.

Time frame: baseline and month 3

Central Contacts

Daniel J Lachant, DO

CONTACT

5852769357 daniel_lachant@urmc.rochester.edu

Data from ClinicalTrials.gov

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