Health TrialsbyHealthPanel

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

ConditionAcute Pulmonary Embolism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Rochester

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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.

Disqualifiers

Pregnancy.

Cardiac Effort >3.5 beats/m during 6MWT.

Resting tachycardia >110 beats/m at hospital discharge.

Chronic Thromboembolic Pulmonary Hypertension

Trial design

Design model

Parallel

Treatments tested in this trial

  • Healthy Living Intervention-1

    Behavioral

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

  • Healthy Living Intervention-2

    Behavioral

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Healthy Living Intervention-1Experimental treatment 1 intervention
Group B: Healthy Living Intervention-2Active comparator 1 intervention

Trial outcomes

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.

Time frame
Baseline and 3 months

Secondary outcomes

1

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
2

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
3

Mean change in 6 minute walk distance

Time frame
baseline and 3 months
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Rochester

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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