Back to resultsHome Rehabilitation After Acute Pulmonary Embolism
Primary Purpose
Pulmonary Embolism
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Daily Activity Text
Control Text
Sponsored by
About this trial
This is an interventional supportive care trial for Pulmonary Embolism
Eligibility Criteria
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
Sites / Locations
- University of Rochester Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Participants who receive daily activity message
Participants who receive control message
Arm Description
The intervention group will receive instructions for a daily activity sent through SMS text message or email.
The control group will receive daily messages to help with blinding sent through text message or email. The messages will not include activity tasks and will include phrases such as "I hope you have a good day".
Outcomes
Primary Outcome Measures
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.
mean change in mean amplitude deviation 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 mean amplitude deviation.
Secondary Outcome Measures
proportion of participants with post-PE syndrome
Participants will be evaluated by a physician to determine if they have post PE-syndrome
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.
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.
mean change in quality of life as measured by PROMIS
The PROMIS questionnaire ranges from 0-99 with higher scores indicating worse outcome.
mean change in quality of life as measured by Emphasis 10
The Emphasis 10 questionnaire ranges from 0-50 with higher scores indicating worse quality of life.
mean change in quality of life as measured by Pulmonary Embolism quality of life questionnaire
The pulmonary embolism quality of life questionnaire ranges from 1 to 27 with higher scores indicating worse outcomes.
mean change in 6 minute walking distance
mean change in heart rate during a 6 minute walk
mean change in oxygen use during a 6 minute walk
Oxygen use will be measured by a measured by portable K5 metabolic analyzer.
mean change in carbon dioxide production during a 6 minute walk
Carbon Dioxide use will be measured by a measured by portable K5 metabolic analyzer.
proportion or subjects who develop chronic thromboembolic pulmonary hypertension
Full Information
NCT ID
NCT05571189
First Posted
October 4, 2022
Last Updated
December 20, 2022
Sponsor
University of Rochester
Collaborators
American College of Chest Physicians
1. Study Identification
Unique Protocol Identification Number
NCT05571189
Brief Title
Home Rehabilitation After Acute Pulmonary Embolism
Official Title
Home Rehabilitation After Acute Pulmonary Embolism
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 19, 2022 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
American College of Chest Physicians
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Participants who receive daily activity message
Arm Type
Experimental
Arm Description
The intervention group will receive instructions for a daily activity sent through SMS text message or email.
Arm Title
Participants who receive control message
Arm Type
Placebo Comparator
Arm Description
The control group will receive daily messages to help with blinding sent through text message or email. The messages will not include activity tasks and will include phrases such as "I hope you have a good day".
Intervention Type
Behavioral
Intervention Name(s)
Daily Activity Text
Intervention Description
Participants will receive a text each day with instructions about the daily activity they should complete for that day.
Intervention Type
Behavioral
Intervention Name(s)
Control Text
Intervention Description
Participants will receive a text each day with no instructions about daily activity. It will have messages like "have a nice day."
Primary Outcome Measure Information:
Title
mean change in vector magnitude count as measured by actigraphy
Description
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
Title
mean change in mean amplitude deviation as measured by actigraphy
Description
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 mean amplitude deviation.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
proportion of participants with post-PE syndrome
Description
Participants will be evaluated by a physician to determine if they have post PE-syndrome
Time Frame
12 weeks
Title
mean change in steps as measured by Actigraph
Description
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
Title
mean change in activity as measured by Actigraph
Description
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
Title
mean change in quality of life as measured by PROMIS
Description
The PROMIS questionnaire ranges from 0-99 with higher scores indicating worse outcome.
Time Frame
12 weeks
Title
mean change in quality of life as measured by Emphasis 10
Description
The Emphasis 10 questionnaire ranges from 0-50 with higher scores indicating worse quality of life.
Time Frame
12 weeks
Title
mean change in quality of life as measured by Pulmonary Embolism quality of life questionnaire
Description
The pulmonary embolism quality of life questionnaire ranges from 1 to 27 with higher scores indicating worse outcomes.
Time Frame
12 weeks
Title
mean change in 6 minute walking distance
Time Frame
12 weeks
Title
mean change in heart rate during a 6 minute walk
Time Frame
12 weeks
Title
mean change in oxygen use during a 6 minute walk
Description
Oxygen use will be measured by a measured by portable K5 metabolic analyzer.
Time Frame
12 weeks
Title
mean change in carbon dioxide production during a 6 minute walk
Description
Carbon Dioxide use will be measured by a measured by portable K5 metabolic analyzer.
Time Frame
12 weeks
Title
proportion or subjects who develop chronic thromboembolic pulmonary hypertension
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Lachant, DO
Phone
5852769357
Email
daniel_lachant@urmc.rochester.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alyssa R Williams, BS
Phone
5852769357
Email
alyssa_williams@urmc.rochester.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Lachant, DO
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Lachant, DO
First Name & Middle Initial & Last Name & Degree
R James White, MD, PhD
First Name & Middle Initial & Last Name & Degree
Dominick Roto, DO
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Home Rehabilitation After Acute Pulmonary Embolism
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