Acute Coronary Syndrome, Acute Myocardial Infarction, Heart Failure, Percutaneous Coronary Intervention, Stable Angina Pectoris
Conditions
Keywords
Cardiac Rehabilitation
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.
Interventions
OTHERCenter-Based Cardiac Rehab
36 center-Based Cardiac Rehab Sessions
OTHERmHealth
Mobile Health Platform
OTHERHome-Based Cardiac Rehab
Encouraged to exercise 3 times per week at home
Sponsors
Mayo Clinic
National Institute of Nursing Research (NINR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Metabolic Equivalents of Task (METS) | Baseline; 3 Months | The change in metabolic equivalents of task (METS) assessed by measuring the energy the body uses during activity relative to resting energy expenditure. |
| Number of Participants Who Were Re-hospitalized During the Trial | 1 Year | The number of participants who were re-hospitalized during the trial. |
| Adherence to the Intervention | Baseline to 3 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index | Baseline; 3 Months | The change in body mass index (BMI) measured from baseline to 3 months. |
| Change in Self-Reported Quality of Life | Baseline; 3 Months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORThomas P Olson, Ph.D., M.S.
Mayo Clinic
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 63.2 years STANDARD_DEVIATION 14.16 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 180 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 197 Participants |
| Region of Enrollment United States | 68 participants |
| Sex: Female, Male Female | 58 Participants |
| Sex: Female, Male Male | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 71 | 0 / 67 | 0 / 68 |
| other Total, other adverse events | 0 / 71 | 0 / 67 | 0 / 68 |
| serious Total, serious adverse events | 0 / 71 | 0 / 67 | 0 / 68 |
Outcome results
None listed