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

NCT06784492 | Recruiting DMC

• 2 other identifiers: STUDY000098951K23HL171867
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Pulmonary Embolism

Keywords

Recovery acute pulmonary embolism; Six minute walk; Cardiac Effort; actigraphy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Mean number of health care visits (Health Care Utilization)

  3 months

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

  baseline and 3 months

• Mean change in 6 minute walk distance

  baseline and 3 months

• Mean change in activity as measured by Actigraph

  baseline and 3 months

• mean change in diagnoses

  baseline and month 3

Study Arms (2)

Healthy Living Intervention-1

EXPERIMENTAL

Participants who receive daily messages about a healthy intervention.

Behavioral: Healthy Living Intervention-1

Healthy Living Intervention-2

ACTIVE COMPARATOR

Participants who receive daily messages about a different healthy intervention.

Behavioral: Healthy Living Intervention-2

Interventions

Healthy Living Intervention-2 BEHAVIORAL

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

Healthy Living Intervention-2

Healthy Living Intervention-1 BEHAVIORAL

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

Healthy Living Intervention-1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking (\>18 years old). Daily messages will be sent in English.
• Acute PE with at least one of the following:
• any right ventricular enlargement or dysfunction on echocardiogram;
• CT Angiogram reporting any right ventricular enlargement; or
• elevated cardiac biomarker (NT-pro BNP or troponin above baseline). Criteria for enrollment will be included on source document.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Rochester: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14620, United States

RECRUITING

Central Study Contacts

Daniel J Lachant, DO

CONTACT

5852769357; daniel_lachant@urmc.rochester.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 20, 2025
• Study Start: February 27, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)