Home Rehabilitation After Acute Pulmonary Embolism

University of Rochester32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Pulmonary Embolism

Interventions

Daily Activity TextBEHAVIORAL

Participants will receive a text each day with instructions about the daily activity they should complete for that day.

Control TextBEHAVIORAL

Participants will receive a text each day with no instructions about daily activity. It will have messages like "have a nice day."

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Rochester Medical Center

Rochester, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 10 weeks

mean change in mean amplitude deviation as measured by actigraphy

Time frame: 10 weeks

Secondary Outcomes

proportion of participants with post-PE syndrome

Participants will be evaluated by a physician to determine if they have post PE-syndrome

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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