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Telehealth-enhanced Hybrid Cardiac Rehabilitation Among Acute Coronary Syndrome Survivors

Primary Purpose

Acute Coronary Syndrome, Myocardial Infarction

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Telehealth-enhanced Hybrid CR

Traditional CR

About this trial

This is an interventional health services research trial for Acute Coronary Syndrome focused on measuring Acute Coronary Syndrome, Myocardial Infarction, Cardiac Rehabilitation, Feasibility, Adherence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

over the age of 18;
can speak and read English or Spanish;
confirmed ACS based on ICD-10 codes; and
had their index event within the past 12 months.

Exclusion Criteria:

severe disabling chronic medical and/or psychiatric comorbidities determined on a case-by-case basis that prevent safe or adequate participation;
high-risk for adverse exercise-related cardiovascular events according to the AACVPR risk stratification criteria;
participated in >1 CR program session;
deemed unable to comply with the protocol (either self-selected or indicated during screening that s/he could not complete all requested tasks). This includes, but is not limited to, patients with a level of cognitive impairment indicative of dementia, patients with current alcohol or substance abuse, patients with a significant movement or balance disorder that interferes with walking, patients with impaired circulation or poor perfusion that may impede pulse oximeter readings, and patients with severe mental illness (e.g., schizophrenia);
home-based environment deemed incompatible with the protocol and/or that prevent safe or adequate participation (either self-selected or indicated during screening/onboarding process); and
unavailable for follow-up for reasons such as terminal illness and imminent plans to leave the United States (as we have migrant or mobile patients due to their citizenship and work issues).

Sites / Locations

Columbia University Irving Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telehealth-enhanced Hybrid CR

Traditional CR

Arm Description

Participants will receive a hybrid version of cardiac rehabilitation.

Participants will receive a standard of care version of cardiac rehabilitation.

Outcomes

Primary Outcome Measures

Number of participants who are successfully enrolled into the pilot study per month

As a measure of enrollment feasibility, the investigator will assess the number of participants who completed recruitment activities and successfully consented and enrolled into the pilot study per month.

Mean proportion of CR sessions completed by participants allocated to the THCR intervention

As a measure of THCR adherence, the investigator will assess the proportion of CR sessions completed by participants allocated to the THCR intervention, which includes 19 home-based + 5 clinic-based sessions.

Secondary Outcome Measures

Proportion of participants that attend ≥1 CR session after randomization in each arm

This is to assess the feasibility of program initiation among participants allocated to each arm. Participants who attended more than 1 CR session will be tallied. Numerator = total number of participants randomized into each arm who attended more than 1 CR session. Denominator = total number of participants randomized into each arm.

Mean proportion of CR sessions completed by those allocated to the traditional CR intervention

As a measure of traditional CR adherence, the investigator will assess the proportion of CR sessions completed by those allocated to the traditional CR intervention, which includes 24 clinic-based sessions.

Proportion of participants who report adequate feasibility of the THCR intervention

The investigator will assess the proportion of participants who report an average score ≥4 (agree or completely agree) for their rating of the patient-perceived THCR intervention's feasibility on the four-item Feasibility of Intervention Measure (FIM). All four items of the FIM are rated on a Likert response scale ranging from 1 to 5 with higher scores indicating greater feasibility. Each Likert response scale rating will be summed (minimum: 4, maximum: 20) and averaged (minimum: 1, maximum: 5) across all four items.

Full Information

NCT ID

NCT05328375

First Posted

April 1, 2022

Last Updated

May 4, 2022

Sponsor

Columbia University

Collaborators

National Institutes of Health (NIH)

1. Study Identification

Unique Protocol Identification Number

NCT05328375

Brief Title

Telehealth-enhanced Hybrid Cardiac Rehabilitation Among Acute Coronary Syndrome Survivors

Official Title

Implementing Telehealth-enhanced Hybrid Cardiac Rehabilitation (THCR) Among Acute Coronary Syndrome Survivors: A Pilot Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 11, 2022 (Actual)

Primary Completion Date

July 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

Collaborators

National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study investigates the feasibility of conducting a randomized controlled trial of telehealth-enhanced hybrid cardiac rehabilitation (THCR) compared with traditional cardiac rehabilitation (CR) among acute coronary syndrome (ACS) survivors. THCR is a novel, hybrid model that targets the same core components as traditional CR (e.g., exercise training, patient education, and risk factor management), but uses a mixture of telehealth, clinic-, and home-based activities to offer 24 CR sessions (5 clinic-based + 19 home-based) over 12 weeks.

Detailed Description

Cardiac Rehabilitation (CR) is a Class I, Level A secondary prevention program that significantly reduces reinfarction and mortality rates in acute coronary syndrome (ACS) survivors. Yet, fewer than 30% of eligible cardiac patients participate in and adhere to CR programs in the United States. One promising avenue for increasing CR participation and adherence is a telehealth-enhanced hybrid CR (THCR) model that combines telehealth, clinic- and home-based CR. Several expert groups have strongly endorsed hybrid CR models that integrate telehealth (i.e., mobile apps, remote monitoring devices) because of their ability to offer the "best of both worlds" (i.e., in-clinic supervision/safety and at-home convenience) while also promoting real-time patient-provider communication and reimbursement as a telemedicine service. Despite its potential, the feasibility of and degree to which THCR improves adherence (e.g., # of completed sessions) and clinical outcomes (e.g., functional capacity) relative to traditional CR requires additional investigation. To understand the feasibility of THCR, the investigator will conduct a single center, two-arm, 1:1 parallel group randomized pilot study comparing THCR with traditional CR among ACS patients (N=40) to evaluate the feasibility (e.g., recruitment, adherence) of conducting an adequately powered randomized controlled trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome, Myocardial Infarction

Keywords

Acute Coronary Syndrome, Myocardial Infarction, Cardiac Rehabilitation, Feasibility, Adherence

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Telehealth-enhanced Hybrid CR

Arm Type

Experimental

Arm Description

Participants will receive a hybrid version of cardiac rehabilitation.

Arm Title

Traditional CR

Arm Type

Active Comparator

Arm Description

Participants will receive a standard of care version of cardiac rehabilitation.

Intervention Type

Behavioral

Intervention Name(s)

Telehealth-enhanced Hybrid CR

Intervention Description

Participants in this group attend a total of 24 CR sessions (5 clinic-based + 19 home-based) over a 12-week period. Clinic-based sessions occur during the first week of the program and at the end of each month. Home-based sessions take place remotely once or twice per week via telehealth, depending on the week of the program. Patients are provided with onboarding sessions, remote patient monitoring devices (tablet, pulse oximeter, blood pressure monitor and cuff) and home-based exercise equipment (e.g., stationary bike and weights). Each CR session (clinic and home) is 60 minutes in duration and includes aerobic and resistance exercise training. Patients will also be asked to complete educational videos, as well as document their physical activity, dietary intake, medication management and homework sessions via surveys. Patients will be encouraged (but not required) to achieve ≥30 minutes of moderate aerobic activity, such as brisk walking, on ≥5 days per week.

Intervention Type

Behavioral

Intervention Name(s)

Traditional CR

Intervention Description

Participants in this group attend a total of 24 clinic-based CR sessions according to standard of care protocols over a 12-week period. Each CR session is 60 minutes in duration and includes aerobic and resistance exercise training. In addition to scheduled sessions, patients will be asked to complete educational videos, as well as document their physical activity, dietary intake, medication management and homework sessions via surveys. Patients will be encouraged (but not required) to achieve ≥30 minutes of moderate aerobic activity, such as brisk walking, on ≥5 days per week.

Primary Outcome Measure Information:

Title

Number of participants who are successfully enrolled into the pilot study per month

Description

Time Frame

Assessed during recruitment and until after enrollment (baseline)

Title

Mean proportion of CR sessions completed by participants allocated to the THCR intervention

Description

Time Frame

Assessed after enrollment (baseline) and until pilot study completion (approximately 12 weeks)

Secondary Outcome Measure Information:

Title

Proportion of participants that attend ≥1 CR session after randomization in each arm

Description

Time Frame

During 12-week follow-up period (Up to 12 weeks)

Title

Mean proportion of CR sessions completed by those allocated to the traditional CR intervention

Description

Time Frame

Assessed after enrollment (baseline) and until pilot study completion (approximately 12 weeks)

Title

Proportion of participants who report adequate feasibility of the THCR intervention

Description

Time Frame

At study completion (approximately 12 weeks)

Other Pre-specified Outcome Measures:

Title

Change in total distance traveled in 6MWT

Description

This is to measure pre-to-post program change in functional capacity (using the six-minute walk test [6MWT]) among THCR and, separately, traditional CR participants. The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. The total distance (meters) traveled over a time period of six minutes is used as the outcome by which to compare changes in performance capacity.

Time Frame

Baseline and 3-month post program completion

Title

Change in health-related quality of life score

Description

This is to measure pre-to-post program change in health-related quality of life (Duke health profile questionnaire [DUKE; physical, mental, social, and general health composite scores]) among THCR and, separately, traditional CR participants. The DUKE is a 17-item self-report questionnaire for measuring generic health-related quality of life over a 1-week time period. Responses are scored to calculate physical health, mental health, and social health scores, which are then summed and divided by 3 to obtain a general health score. The general health score ranges from 0 - 100, with high scores indicating better health-related quality of life.

Time Frame

Baseline and 3-month post program completion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: over the age of 18; can speak and read English or Spanish; confirmed ACS based on ICD-10 codes; and had their index event within the past 12 months. Exclusion Criteria: severe disabling chronic medical and/or psychiatric comorbidities determined on a case-by-case basis that prevent safe or adequate participation; high-risk for adverse exercise-related cardiovascular events according to the AACVPR risk stratification criteria; participated in >1 CR program session; deemed unable to comply with the protocol (either self-selected or indicated during screening that s/he could not complete all requested tasks). This includes, but is not limited to, patients with a level of cognitive impairment indicative of dementia, patients with current alcohol or substance abuse, patients with a significant movement or balance disorder that interferes with walking, patients with impaired circulation or poor perfusion that may impede pulse oximeter readings, and patients with severe mental illness (e.g., schizophrenia); home-based environment deemed incompatible with the protocol and/or that prevent safe or adequate participation (either self-selected or indicated during screening/onboarding process); and unavailable for follow-up for reasons such as terminal illness and imminent plans to leave the United States (as we have migrant or mobile patients due to their citizenship and work issues).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andrea T Duran, PhD

Phone

212-342-4491

atd2127@cumc.columbia.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Alexandra Miecznikowski, MPH

Phone

212-342-4507

as5068@cumc.columbia.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrea T Duran, PhD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Daichi Shimbo, MD

Organizational Affiliation

Columbia University

Official's Role

Study Director

Facility Information:

Facility Name

Columbia University Irving Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andrea T Duran, PhD

Phone

212-342-4491

atd2127@cumc.columbia.edu

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31931615

Citation

Ritchey MD, Maresh S, McNeely J, Shaffer T, Jackson SL, Keteyian SJ, Brawner CA, Whooley MA, Chang T, Stolp H, Schieb L, Wright J. Tracking Cardiac Rehabilitation Participation and Completion Among Medicare Beneficiaries to Inform the Efforts of a National Initiative. Circ Cardiovasc Qual Outcomes. 2020 Jan;13(1):e005902. doi: 10.1161/CIRCOUTCOMES.119.005902. Epub 2020 Jan 14.

Results Reference

background

PubMed Identifier

31082266

Citation

Thomas RJ, Beatty AL, Beckie TM, Brewer LC, Brown TM, Forman DE, Franklin BA, Keteyian SJ, Kitzman DW, Regensteiner JG, Sanderson BK, Whooley MA. Home-Based Cardiac Rehabilitation: A Scientific Statement From the American Association of Cardiovascular and Pulmonary Rehabilitation, the American Heart Association, and the American College of Cardiology. Circulation. 2019 Jul 2;140(1):e69-e89. doi: 10.1161/CIR.0000000000000663. Epub 2019 May 13.

Results Reference

background

PubMed Identifier

25249585

Citation

Amsterdam EA, Wenger NK, Brindis RG, Casey DE Jr, Ganiats TG, Holmes DR Jr, Jaffe AS, Jneid H, Kelly RF, Kontos MC, Levine GN, Liebson PR, Mukherjee D, Peterson ED, Sabatine MS, Smalling RW, Zieman SJ; ACC/AHA Task Force Members. 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Dec 23;130(25):e344-426. doi: 10.1161/CIR.0000000000000134. Epub 2014 Sep 23. No abstract available. Erratum In: Circulation. 2014 Dec 23;130(25):e433-4. Dosage error in article text.

Results Reference

background

PubMed Identifier

22052934

Citation

Smith SC Jr, Benjamin EJ, Bonow RO, Braun LT, Creager MA, Franklin BA, Gibbons RJ, Grundy SM, Hiratzka LF, Jones DW, Lloyd-Jones DM, Minissian M, Mosca L, Peterson ED, Sacco RL, Spertus J, Stein JH, Taubert KA; World Heart Federation and the Preventive Cardiovascular Nurses Association. AHA/ACCF Secondary Prevention and Risk Reduction Therapy for Patients with Coronary and other Atherosclerotic Vascular Disease: 2011 update: a guideline from the American Heart Association and American College of Cardiology Foundation. Circulation. 2011 Nov 29;124(22):2458-73. doi: 10.1161/CIR.0b013e318235eb4d. Epub 2011 Nov 3. No abstract available. Erratum In: Circulation. 2015 Apr 14;131(15):e408.

Results Reference

background

PubMed Identifier

31423874

Citation

Imran HM, Baig M, Erqou S, Taveira TH, Shah NR, Morrison A, Choudhary G, Wu WC. Home-Based Cardiac Rehabilitation Alone and Hybrid With Center-Based Cardiac Rehabilitation in Heart Failure: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2019 Aug 20;8(16):e012779. doi: 10.1161/JAHA.119.012779. Epub 2019 Aug 17.

Results Reference

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Telehealth-enhanced Hybrid Cardiac Rehabilitation Among Acute Coronary Syndrome Survivors

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