Ignite Creation Date:
2024-05-06 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05328375
Status:
SUSPENDED
Last Update Posted:
2024-02-06
First Post:
2022-04-01
Brief Title:
Telehealth-enhanced Hybrid Cardiac Rehabilitation Among Acute Coronary Syndrome Survivors
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Implementing Telehealth-enhanced Hybrid Cardiac Rehabilitation THCR Among Acute Coronary Syndrome Survivors A Pilot Randomized Controlled Trial
Status:
SUSPENDED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Telehealth Vendor Transition
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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 ie mobile apps remote monitoring devices because of their ability to offer the best of both worlds ie in-clinic supervisionsafety 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 eg of completed sessions and clinical outcomes eg functional capacity relative to traditional CR requires additional investigation To understand the feasibility of THCR the investigator will conduct a single center two-arm 11 parallel group randomized pilot study comparing THCR with traditional CR among ACS patients N40 to evaluate the feasibility eg recruitment adherence of conducting an adequately powered randomized controlled trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KL2TR001874 | NIH | None | httpsreporternihgovquickSearchKL2TR001874 |