Incorporating Healthy Living Strategies to Aid in Recovery After Acute Pulmonary Embolism
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Healthy Living Intervention-1, Healthy Living Intervention-2.
- Who it may be relevant to
- Registry conditions: Acute Pulmonary Embolism. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Recovery After Acute Pulmonary Embolism
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.
Interventions
- Behavioral Healthy Living Intervention-1
Participants will receive a text or email each day with instructions about a healthy intervention. - Behavioral Healthy Living Intervention-2
Participants will receive a text or email each day with instructions about a healthy intervention.
Primary outcome measures
- Mean change in cardiac effort [Time frame: Baseline and 3 months]
Secondary outcome measures (5)
- Mean number of health care visits (Health Care Utilization) [Time frame: 3 months]
- Mean change in Pulmonary Embolism Quality of Life Questionnaire (PEQOL) Score [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 [Time frame: baseline and 3 months]
- mean change in diagnoses [Time frame: baseline and month 3]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Rochester Medical Center — Rochester
Identifiers
NCT: NCT06784492 · STUDY00009895 · 1K23HL171867