Effect of a Virtually Implemented Cardiac Rehabilitation Program

NCT05201976 | Completed

• 1 other identifier: 848902
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Change in VO2 max (ml/kg/min)

  Cardiorespiratory fitness as assessed by maximal VO2

  At baseline visit and at the end of study approximately 40 weeks

Secondary Outcomes (8)

• Attendance

  Mean number of cardiac rehab sessions completed per patient, over the course of 12 weeks or 36 sessions.

• Quality of Life questionnaire

  Prior to beginning of cardiac rehabilitation and then at completion of cardiac rehabilitation program approximately 36 weeks

• Blood Pressure

  Start of each cardiac rehab session, over the course of 12 weeks or 36 sessions.

• Major adverse cardiovascular events (MACE)

  Events will be collected up to 27 months post study enrollment

• Survey

  At completion of cardiac rehabilitation program approximately 36 weeks

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Virtual cardiac rehab program delivered through the CardaHealth platform.

Other: Virtually administered Cardiac Rehab program

Control

ACTIVE COMPARATOR

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

Other: Standard of Care in person Cardiac Rehab Program

Interventions

Virtually administered Cardiac Rehab program OTHER

Virtual cardiac rehab program delivered through the CardaHealth platform.

Intervention

Standard of Care in person Cardiac Rehab Program OTHER

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Independence Blue Cross: collaborator
• CardaHealth: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19054, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Srinath Adusumalli, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Neel Chokshi, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, non-inferiority, Case vs. Control (1 to 1)

Study Record Dates

• First Submitted: December 5, 2021
• First Posted: January 21, 2022
• Study Start: November 8, 2021
• Primary Completion: October 15, 2024
• Study Completion: October 15, 2024
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)