Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01NR018832 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Center-Based Cardiac Rehab (CON) | Active Comparator | 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. |
|
| Conventional Center-Based Cardiac Rehab + mHealth (CON+) | Active Comparator | 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. |
|
| Home-Based Cardiac Rehab + mHealth (HOM+) | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Center-Based Cardiac Rehab | Other | 36 center-Based Cardiac Rehab Sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Metabolic Equivalents of Task (METS) | The change in metabolic equivalents of task (METS) assessed by measuring the energy the body uses during activity relative to resting energy expenditure. | Baseline; 3 Months |
| Number of Participants Who Were Re-hospitalized During the Trial | The number of participants who were re-hospitalized during the trial. | 1 Year |
| Adherence to the Intervention | The percentage of completed visits per participant that were attended from the start of the intervention (baseline) to the end of the intervention (3 months) relative to the number of prescribed visits per participant. | Baseline to 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Mass Index | The change in body mass index (BMI) measured from baseline to 3 months. | Baseline; 3 Months |
| Change in Self-Reported Quality of Life | The change in self-reported quality of life assessed using the Patient Health Questionnaire 9-item (PHQ-9) scale used to assess severity of depression. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score ranges from 0 to 27 where 0 is no depression, 1-4 is minimal depression, 5-9 is mild depression, 10-14 is moderate depression, and 15-19 is moderately severe depression and 20-27 severe depression. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thomas P Olson, Ph.D., M.S. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States | ||
| Mayo Clinic |
Not provided
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Conventional Center-Based Cardiac Rehab (CON) | Participants were 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 had direct access to the medical director, case manager, registered nurse, exercise physiologist, and stress management specialists. Center-Based Cardiac Rehab: 36 center-Based Cardiac Rehab Sessions |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 11, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| mHealth | Other | Mobile Health Platform |
|
| Home-Based Cardiac Rehab | Other | Encouraged to exercise 3 times per week at home |
|
| Baseline; 3 Months |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| FG001 | Conventional Center-Based Cardiac Rehab + mHealth (CON+) | Participants were prescribed 36 sessions of center-based CR as noted above. In addition, participants were 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 allowed patients to communicate via secure network with other patients who were part of their invited network. The Social Network Module also allowed for secure two-way interaction with healthcare providers in the event that patients were experiencing signs or symptoms suggestive of worsening condition. This platform also contained 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. Center-Based Cardiac Rehab: 36 center-Based Cardiac Rehab Sessions mHealth: Mobile Health Platform |
| FG002 | Home-Based Cardiac Rehab + mHealth (HOM+) | Participants were provided paper copies of educational content at the time of event/discharge. In addition, these participants were provided access to the same mHealth platform as the CON+ group. Participants in this group were 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 were tracked using web/internet analytics. mHealth: Mobile Health Platform Home-Based Cardiac Rehab: Encouraged to exercise 3 times per week at home |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Conventional Center-Based Cardiac Rehab (CON) | Participants were 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 had direct access to the medical director, case manager, registered nurse, exercise physiologist, and stress management specialists. Center-Based Cardiac Rehab: 36 center-Based Cardiac Rehab Sessions |
| BG001 | Conventional Center-Based Cardiac Rehab + mHealth (CON+) | Participants were prescribed 36 sessions of center-based CR as noted above. In addition, participants were 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 allowed patients to communicate via secure network with other patients who were part of their invited network. The Social Network Module also allowed for secure two-way interaction with healthcare providers in the event that patients were experiencing signs or symptoms suggestive of worsening condition. This platform also contained 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. Center-Based Cardiac Rehab: 36 center-Based Cardiac Rehab Sessions mHealth: Mobile Health Platform |
| BG002 | Home-Based Cardiac Rehab + mHealth (HOM+) | Participants were provided paper copies of educational content at the time of event/discharge. In addition, these participants were provided access to the same mHealth platform as the CON+ group. Participants in this group were 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 were tracked using web/internet analytics. mHealth: Mobile Health Platform Home-Based Cardiac Rehab: Encouraged to exercise 3 times per week at home |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Metabolic Equivalents of Task (METS) | The change in metabolic equivalents of task (METS) assessed by measuring the energy the body uses during activity relative to resting energy expenditure. | 10 participants in the CON arm, 9 participants in the CON+ arm and 1 participant in the HOM+ did not complete the METS measurement at the 3-month mark. | Posted | Median | Inter-Quartile Range | mL/kg/min | Baseline; 3 Months |
|
|
| |||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Were Re-hospitalized During the Trial | The number of participants who were re-hospitalized during the trial. | Posted | Count of Participants | Participants | 1 Year |
| |||||||||||||||||||||||||||||||||||
| Primary | Adherence to the Intervention | The percentage of completed visits per participant that were attended from the start of the intervention (baseline) to the end of the intervention (3 months) relative to the number of prescribed visits per participant. | Posted | Median | Inter-Quartile Range | percentage of completed visits | Baseline to 3 Months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change in Body Mass Index | The change in body mass index (BMI) measured from baseline to 3 months. | 2 participants in the CON arm and 2 participants in the CON+ arm did not complete the BMI measurement at the baseline mark. 9 participants in the CON arm, 12 participants in the CON+ arm and 3 participants in the HOM+ arm did not complete the BMI measurement at the 3-month mark. | Posted | Median | Inter-Quartile Range | kg/m^2 | Baseline; 3 Months |
| |||||||||||||||||||||||||||||||||
| Secondary | Change in Self-Reported Quality of Life | The change in self-reported quality of life assessed using the Patient Health Questionnaire 9-item (PHQ-9) scale used to assess severity of depression. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score ranges from 0 to 27 where 0 is no depression, 1-4 is minimal depression, 5-9 is mild depression, 10-14 is moderate depression, and 15-19 is moderately severe depression and 20-27 severe depression. | 10 participants in the CON arm, 12 participants in the CON+ arm and 7 participants in the HOM+ arm did not complete the PHQ-9 at the baseline mark. 30 participants in the CON arm, 32 participants in the CON+ arm and 8 participants in the HOM+ arm did not complete the PHQ-9 at the 3-month mark. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline; 3 Months |
|
Adverse events were collected from the time of informed consent through study completion, approximately 1 year.
The definition of adverse events differed slightly from the clinicaltrials.gov definition in that only adverse events deemed related to the study were recorded/reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Conventional Center-Based Cardiac Rehab (CON) | Participants were 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 had direct access to the medical director, case manager, registered nurse, exercise physiologist, and stress management specialists. Center-Based Cardiac Rehab: 36 center-Based Cardiac Rehab Sessions | 0 | 71 | 0 | 71 | 0 | 71 |
| EG001 | Conventional Center-Based Cardiac Rehab + mHealth (CON+) | Participants were prescribed 36 sessions of center-based CR as noted above. In addition, participants were 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 allowed patients to communicate via secure network with other patients who were part of their invited network. The Social Network Module also allowed for secure two-way interaction with healthcare providers in the event that patients were experiencing signs or symptoms suggestive of worsening condition. This platform also contained 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. Center-Based Cardiac Rehab: 36 center-Based Cardiac Rehab Sessions mHealth: Mobile Health Platform | 0 | 67 | 0 | 67 | 0 | 67 |
| EG002 | Home-Based Cardiac Rehab + mHealth (HOM+) | Participants were provided paper copies of educational content at the time of event/discharge. In addition, these participants were provided access to the same mHealth platform as the CON+ group. Participants in this group were 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 were tracked using web/internet analytics. mHealth: Mobile Health Platform Home-Based Cardiac Rehab: Encouraged to exercise 3 times per week at home | 0 | 68 | 0 | 68 | 0 | 68 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Olson, Ph.D., M.S. | Mayo Clinic | 507-284-4441 | olson.thomas2@mayo.edu |
| Mar 20, 2026 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 27, 2024 | Nov 7, 2025 | ICF_000.pdf |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D060050 | Angina, Stable |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | Home-Based Cardiac Rehab + mHealth (HOM+) | Participants were provided paper copies of educational content at the time of event/discharge. In addition, these participants were provided access to the same mHealth platform as the CON+ group. Participants in this group were 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 were tracked using web/internet analytics. mHealth: Mobile Health Platform Home-Based Cardiac Rehab: Encouraged to exercise 3 times per week at home |
|
|
| OG002 | Home-Based Cardiac Rehab + mHealth (HOM+) | Participants were provided paper copies of educational content at the time of event/discharge. In addition, these participants were provided access to the same mHealth platform as the CON+ group. Participants in this group were 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 were tracked using web/internet analytics. mHealth: Mobile Health Platform Home-Based Cardiac Rehab: Encouraged to exercise 3 times per week at home |
|
|
| OG002 | Home-Based Cardiac Rehab + mHealth (HOM+) | Participants were provided paper copies of educational content at the time of event/discharge. In addition, these participants were provided access to the same mHealth platform as the CON+ group. Participants in this group were 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 were tracked using web/internet analytics. mHealth: Mobile Health Platform Home-Based Cardiac Rehab: Encouraged to exercise 3 times per week at home |
|
|
Participants were prescribed 36 sessions of center-based CR as noted above. In addition, participants were 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 allowed patients to communicate via secure network with other patients who were part of their invited network. The Social Network Module also allowed for secure two-way interaction with healthcare providers in the event that patients were experiencing signs or symptoms suggestive of worsening condition. This platform also contained 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. Center-Based Cardiac Rehab: 36 center-Based Cardiac Rehab Sessions mHealth: Mobile Health Platform |
| OG002 | Home-Based Cardiac Rehab + mHealth (HOM+) | Participants were provided paper copies of educational content at the time of event/discharge. In addition, these participants were provided access to the same mHealth platform as the CON+ group. Participants in this group were 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 were tracked using web/internet analytics. mHealth: Mobile Health Platform Home-Based Cardiac Rehab: Encouraged to exercise 3 times per week at home |
|
|