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Mobile Case Management for Heart Rehabilitation (iCARE Trial)

N/A

Recruiting

Led By Thomas P Olson, Ph.D., M.S.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

iCARE Trial Summary

This trial is testing if doing cardiac rehab at home is just as effective as coming in to the clinic.

Who is the study for?

This trial is for heart patients with conditions like a recent heart attack, angina, or those who've had certain heart surgeries. Participants need to have access to a smartphone or computer with internet and an email address. It's not for those using ventricular assist devices.Check my eligibility

What is being tested?

The study is testing if cardiac rehabilitation done at home (with or without clinic visits) can be as effective as the traditional approach of only attending sessions in a medical center.See study design

What are the potential side effects?

Since this trial involves non-drug interventions like exercise and education programs, side effects may include typical risks associated with physical activity such as muscle soreness or strain.

iCARE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a history of heart issues, including heart attack, stable chest pain, heart surgery, or heart failure.

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I had heart surgery that requires cardiac rehab.

iCARE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Functional Capacity

Number of participants who are re-hospitalized during the trial

Secondary outcome measures

6 Minute Walk Test

Change in Body Weight

Fasting Basic Lipid Panel

+6 more

iCARE Trial Design

3Treatment groups

Active Control

Group I: Conventional Center-Based Cardiac Rehab + mHealth (CON+)Active Control2 Interventions

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 II: Conventional Center-Based Cardiac Rehab (CON)Active Control1 Intervention

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 III: Home-Based Cardiac Rehab + mHealth (HOM+)Active Control2 Interventions

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.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,209 Previous Clinical Trials

3,766,801 Total Patients Enrolled

6 Trials studying Acute Coronary Syndrome

6,966 Patients Enrolled for Acute Coronary Syndrome

National Institute of Nursing Research (NINR)NIH

580 Previous Clinical Trials

10,376,228 Total Patients Enrolled

Thomas P Olson, Ph.D., M.S.Principal InvestigatorMayo Clinic

1 Previous Clinical Trials

187 Total Patients Enrolled

Media Library

Center-Based Cardiac Rehab Clinical Trial Eligibility Overview. Trial Name: NCT04938661 — N/A

Acute Coronary Syndrome Research Study Groups: Conventional Center-Based Cardiac Rehab + mHealth (CON+), Conventional Center-Based Cardiac Rehab (CON), Home-Based Cardiac Rehab + mHealth (HOM+)

Acute Coronary Syndrome Clinical Trial 2023: Center-Based Cardiac Rehab Highlights & Side Effects. Trial Name: NCT04938661 — N/A

Center-Based Cardiac Rehab 2023 Treatment Timeline for Medical Study. Trial Name: NCT04938661 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What goals is this study attempting to achieve?

"This 1-year clinical trial aims to assess the Functional Capacity of participants. Secondary outcomes include Exercise Capacity, Body Weight Change and Fasting Basic Lipid Panel measurements, which are performed at enrolment and two follow-up visits in Mayo Clinic laboratories."

Answered by AI

Are seniors aged 85 and under able to partake in this clinical exploration?

"The requirements for inclusion in this trial necessitates that the patient must be between 18 to 80 years old. For those under 18, there are 36 trials currently running and 1196 clinical studies available should someone exceed 65 years of age."

Answered by AI

To what extent does one need to meet the criteria for joining this research project?

"This clinical trial seeks to enroll 333 patients suffering from heart failure aged 18-80. To qualify, applicants must possess a smartphone or desktop computer with access to the internet, own an email address and have experienced one of the following: AMI/ACS, stable angina pectoris, percutaneous coronary intervention (PCI), cardiac rehab due to bypass surgery/valve repair/transplantation."

Answered by AI

How many participants are currently involved in this research endeavor?

"That is correct. Per clinicaltrials.gov, this medical research initiative was initially published on July 8th 2021 and has since been updated on August 19th 2022. To complete the trial's objectives, 333 patients must be recruited from two different sites."

Answered by AI

Is this experiment available to participants at the present moment?

"Affirmative. As evidenced by the information on clinicaltrials.gov, this trial is currently recruiting volunteers; it was first posted on July 8th 2021 and recently updated on August 19th 2022. The study requires 333 individuals to be recruited from 2 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE)

Thomas P. Olson, M.S., Ph.D. 2021. "Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04938661.

All > Heart Attack > Heart Failure