Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE)

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-08

Study Completion Date

2025-06-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this research is to find out if doing cardiac rehab at home, or a mix of cardiac rehab at home and in the clinic, is as effective as coming in to the clinic for cardiac rehab.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study on the Efficacy and Mechanism of Cardiac Rehabilitation for Stem Cell Mobilization and Heart Failure Improvement

NCT00154466

Myocardial Infarction

COMPLETED NA

The Improving ATTENDance to Cardiac Rehabilitation Trial

NCT03646760

Myocardial Infarction Heart Failure Heart Valve Diseases +3 more

COMPLETED NA

Home-based Cardiac Rehabilitation in Heart Failure

NCT06349941

Heart Failure

RECRUITING PHASE3

Adapted Cardiac Rehabilitation After Stroke

NCT01067495

Stroke

COMPLETED PHASE1

Effects of Intelligent Tele-Cardiopulmonary Exercise System on Rehabilitation for Patients With Myocardial Infarction

NCT01250600

Exercise Capacity

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

To address our specific aims we will use a single-center, prospective, three-arm, parallel group, randomized controlled trial design. At the time of identification of eligibility for participation, patients will be randomized to one of three arms (1:1:1 ratio): Arm 1 consists of patients randomized to conventional cardiac rehab only, Arm 2 consists of patients randomized to conventional cardiac rehab with the addition of the mHealth platform, and Arm 3 consists of patients randomized to remote case management using the mHealth platform only. Clinical metrics will include traditional cardiovascular risk factors with additional tracking of service utilization and adherence, and quality of life. Measures will be made at baseline (pre-intervention) and \~3-months (coinciding with completion of conventional CR). Additional follow-up will occur at 12 months post CR entry. Randomization to study arms will be done with a multidimensional dynamic allocation algorithm, minimizing imbalances in age, sex, body mass index, and race across study arms.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Myocardial Infarction Acute Coronary Syndrome Stable Angina Pectoris Percutaneous Coronary Intervention Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Conventional Center-Based Cardiac Rehab (CON)

Participants will be prescribed 36 sessions of center-based CR. This includes supervised exercise sessions, cooking demonstrations, didactic lectures, video presentations, group support, and stress management education. During sessions, participants have direct access to the medical director, case manager, registered nurse, exercise physiologist, and stress management specialists.

Group Type ACTIVE_COMPARATOR

Center-Based Cardiac Rehab

Intervention Type OTHER

36 center-Based Cardiac Rehab Sessions

Conventional Center-Based Cardiac Rehab + mHealth (CON+)

Participants will be prescribed 36 sessions of center-based CR as noted above. In addition, participants will be provided access to the mHealth platform which provides "e-Learning modules" with factsheets, videos, quizzes, and questionnaires (coinciding with activities being conducted during the CON program), a Social Network Module will allow patients to communicate via secure network with other patients who are part of their invited network. The Social Network Module also allows for secure two-way interaction with healthcare providers in the event that patients are experiencing signs or symptoms suggestive of worsening condition. This platform also contains a Personal Health Record Module allowing patients to upload, archive, and retrieve personal health data (e.g. fitness tracker data, heart rate monitor data, blood pressure recordings, etc.) and record vital signs, symptoms, treatments, and medical history.

Group Type ACTIVE_COMPARATOR

Center-Based Cardiac Rehab

Intervention Type OTHER

36 center-Based Cardiac Rehab Sessions

mHealth

Intervention Type OTHER

Mobile Health Platform

Home-Based Cardiac Rehab + mHealth (HOM+)

Participants will be provided paper copies of educational content at the time of event/discharge. In addition, these participants will be provided access to the same mHealth platform as the CON+ group. Participants in this group will be encouraged to exercise three days per week while also completing the additional questionnaires and educational content provided by the mHealth platform in accordance with the CR program. Participation will be tracked using web/internet analytics.

Group Type ACTIVE_COMPARATOR

mHealth

Intervention Type OTHER

Mobile Health Platform

Home-Based Cardiac Rehab

Intervention Type OTHER

Encouraged to exercise 3 times per week at home

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Center-Based Cardiac Rehab

36 center-Based Cardiac Rehab Sessions

Intervention Type OTHER

mHealth

Mobile Health Platform

Intervention Type OTHER

Home-Based Cardiac Rehab

Encouraged to exercise 3 times per week at home

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Own or have reliable access to a smartphone or desktop computer with internet access
* Have an email address
* Patients who have a history of one of the following; acute myocardial infarction/acute coronary syndrome, stable angina pectoris, percutaneous coronary intervention, or heart failure.
* Patients who have undergone a surgical procedure which includes an indication for cardiac rehabilitation (coronary artery bypass surgery, heart valve repair/replacement, or heart transplant)