Effect of a Virtually Implemented Cardiac Rehabilitation Program

NCT ID: NCT05201976

Last Updated: 2024-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-08

Study Completion Date

2024-10-15

Brief Summary

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A clinical trial investigating the effects of a virtually implemented home-based cardiac rehab program with real-time, video based exercise supervision and vitals monitoring.

Detailed Description

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This study will use a randomized, controlled trial design to test the effectiveness of a virtually implemented cardiac rehabilitation (CR) program with real-time, video based supervised exercise and vitals monitoring as compared to traditional center based rehab in patients with a clinical indication for cardiac rehab. The primary outcome of effectiveness will be change in cardiorespiratory fitness as assessed by maximal VO2 achieved at the start of CR and on upon completion of CR.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, non-inferiority, Case vs. Control (1 to 1)
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Study Groups

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Intervention

Virtual cardiac rehab program delivered through the CardaHealth platform.

Group Type ACTIVE_COMPARATOR

Virtually administered Cardiac Rehab program

Intervention Type OTHER

Virtual cardiac rehab program delivered through the CardaHealth platform.

Control

Clinically ordered standard of care cardiac rehab program (in-person).

Group Type ACTIVE_COMPARATOR

Standard of Care in person Cardiac Rehab Program

Intervention Type OTHER

Clinically ordered standard of care cardiac rehab program (in-person).

Interventions

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Virtually administered Cardiac Rehab program

Virtual cardiac rehab program delivered through the CardaHealth platform.

Intervention Type OTHER

Standard of Care in person Cardiac Rehab Program

Clinically ordered standard of care cardiac rehab program (in-person).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients who have been prescribed cardiac rehabilitation as part of their standard of care

Exclusion Criteria

* Patients with significant exercise limitations other than cardiovascular disease
* Patients who are unable to exercise in home
* Patients with active cancer treatment
* Patients who do not have an email address or a cell phone
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Independence Blue Cross

OTHER

Sponsor Role collaborator

CardaHealth

UNKNOWN

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Neel Chokshi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Srinath Adusumalli, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Neel Chokshi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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848902

Identifier Type: -

Identifier Source: org_study_id

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