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Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE) (iCARE)

Primary Purpose

Acute Myocardial Infarction, Acute Coronary Syndrome, Stable Angina Pectoris

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Center-Based Cardiac Rehab
mHealth
Home-Based Cardiac Rehab
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Myocardial Infarction focused on measuring Cardiac Rehabilitation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Exclusion Criteria:

  • Patients referred to cardiac rehab with ventricular assist devices.

Sites / Locations

  • University of Minnesota
  • Mayo ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Conventional Center-Based Cardiac Rehab (CON)

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

Home-Based Cardiac Rehab + mHealth (HOM+)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Functional Capacity
VO2 peak
Number of participants who are re-hospitalized during the trial
We will look at the number of patients who are hospitalized for any reason during the follow-up period

Secondary Outcome Measures

Change in Body Weight
body weight will be measured from pre to post intervention to see if weight decreases
Fasting Basic Lipid Panel
All fasting blood chemistry measures will be conducted by standard clinical protocols in the Mayo Clinic laboratories. These measures will be conducted at the time of enrollment in the research program and during each of the two follow-up study visits.
Fasting Blood Glucose
All fasting blood chemistry measures will be conducted by standard clinical protocols in the Mayo Clinic laboratories. These measures will be conducted at the time of enrollment in the research program and during each of the two follow-up study visits.
Fasting Hemoglobin
All fasting blood chemistry measures will be conducted by standard clinical protocols in the Mayo Clinic laboratories. These measures will be conducted at the time of enrollment in the research program and during each of the two follow-up study visits.
Fasting Hemoglobin A1C
All fasting blood chemistry measures will be conducted by standard clinical protocols in the Mayo Clinic laboratories. These measures will be conducted at the time of enrollment in the research program and during each of the two follow-up study visits.
6 Minute Walk Test
exercise capacity
Self-Reported Physical Activity
assessed via IPAQ questionnaire
Self-Reported Physical Activity
assessed via DASI questionnaire
Self-Reported Dietary Patterns
obtained using a standard food frequency questionnaire
Self-Reported Quality of Life
Assessed using PHQ-9
Self-Reported Quality of Life
Assessed using Darmouth 9-item short-form health survey

Full Information

First Posted
May 14, 2021
Last Updated
August 28, 2023
Sponsor
Mayo Clinic
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT04938661
Brief Title
Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE)
Acronym
iCARE
Official Title
Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2021 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction, Acute Coronary Syndrome, Stable Angina Pectoris, Percutaneous Coronary Intervention, Heart Failure
Keywords
Cardiac Rehabilitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
333 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional Center-Based Cardiac Rehab (CON)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Conventional Center-Based Cardiac Rehab + mHealth (CON+)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Home-Based Cardiac Rehab + mHealth (HOM+)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Center-Based Cardiac Rehab
Intervention Description
36 center-Based Cardiac Rehab Sessions
Intervention Type
Other
Intervention Name(s)
mHealth
Intervention Description
Mobile Health Platform
Intervention Type
Other
Intervention Name(s)
Home-Based Cardiac Rehab
Intervention Description
Encouraged to exercise 3 times per week at home
Primary Outcome Measure Information:
Title
Functional Capacity
Description
VO2 peak
Time Frame
3 Months
Title
Number of participants who are re-hospitalized during the trial
Description
We will look at the number of patients who are hospitalized for any reason during the follow-up period
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Change in Body Weight
Description
body weight will be measured from pre to post intervention to see if weight decreases
Time Frame
3 Months
Title
Fasting Basic Lipid Panel
Description
All fasting blood chemistry measures will be conducted by standard clinical protocols in the Mayo Clinic laboratories. These measures will be conducted at the time of enrollment in the research program and during each of the two follow-up study visits.
Time Frame
3 Months
Title
Fasting Blood Glucose
Description
All fasting blood chemistry measures will be conducted by standard clinical protocols in the Mayo Clinic laboratories. These measures will be conducted at the time of enrollment in the research program and during each of the two follow-up study visits.
Time Frame
3 Months
Title
Fasting Hemoglobin
Description
All fasting blood chemistry measures will be conducted by standard clinical protocols in the Mayo Clinic laboratories. These measures will be conducted at the time of enrollment in the research program and during each of the two follow-up study visits.
Time Frame
3 Months
Title
Fasting Hemoglobin A1C
Description
All fasting blood chemistry measures will be conducted by standard clinical protocols in the Mayo Clinic laboratories. These measures will be conducted at the time of enrollment in the research program and during each of the two follow-up study visits.
Time Frame
3 Months
Title
6 Minute Walk Test
Description
exercise capacity
Time Frame
3 Months
Title
Self-Reported Physical Activity
Description
assessed via IPAQ questionnaire
Time Frame
3 Months
Title
Self-Reported Physical Activity
Description
assessed via DASI questionnaire
Time Frame
3 Months
Title
Self-Reported Dietary Patterns
Description
obtained using a standard food frequency questionnaire
Time Frame
3 Months
Title
Self-Reported Quality of Life
Description
Assessed using PHQ-9
Time Frame
3 Months
Title
Self-Reported Quality of Life
Description
Assessed using Darmouth 9-item short-form health survey
Time Frame
3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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) Exclusion Criteria: Patients referred to cardiac rehab with ventricular assist devices.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas P Olson, Ph.D., M.S.
Phone
507-284-4441
Email
olson.thomas2@mayo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Subban Hassan
Phone
507-255-0607
Email
Hassan.Subban@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas P Olson, Ph.D., M.S.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Subban Hassan
Phone
507-255-0607
Email
Hassan.Subban@mayo.edu
First Name & Middle Initial & Last Name & Degree
Thomas P Olson, Ph.D; M.S.

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE)

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