Johns Hopkins University
Baltimore, Maryland, 21287, United States
NCT Number: NCT05238103
In this randomized clinical trial, the researchers are investigating whether a multi-component virtual/hybrid cardiac rehabilitation program will improve functional status, cholesterol level, overall cardiovascular health, individual risk factors, quality of life and mental health for patients who have recently been diagnosed with myocardial infarction, received a coronary stent, underwent heart surgery or catheter-based valve replacement, as compared to traditional, center-based cardiac rehabilitation.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Baltimore, Maryland, 21287, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The Corrie Hybrid Cardiac Rehabilitation Program is a multi-component intervention. It consists of the Corrie smartphone app for cardiovascular health optimization which is paired with wristband device (Apple Watch or Fitbit), Bluetooth-enabled Omron blood pressure monitor and exercise resistance bands. The program also includes individualized treatment plan development, setting health goals and communication with trained Corrie Health Coach. Furthermore, the intervention includes motivational text messages sent to participants throughout the study to aid with risk factor modification.
Time frame: 12 weeks after randomization
Mean difference in 6 minute walk distance, between Intervention and Control groups, as measured at final study visit occurring at 12 weeks after randomization.
Time frame: 12 weeks after randomization
The cardiovascular health metric for secondary prevention (adapted from American Heart Association's Life Simple 7). The score ranges from 0 to 14 with higher score indicating better cardiovascular health.
Time frame: 12 weeks after randomization
Systolic blood pressure and Diastolic blood pressure
Time frame: 12 weeks after randomization
LDL cholesterol level (in mg/dl) measured through blood sample drawn at 12 week follow up visit
Time frame: 12 weeks after randomization
Glycosylated hemoglobin (HbA1c) level (%) measured through blood sample drawn at 12 week follow up visit
Time frame: 12 weeks after randomization
BMI = weight (kg) / height in meters squared (m^2). Weight and height measured by study staff at study visit.
Time frame: 12 weeks after randomization
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10: The 10-item patient-reported questionnaire administered at 12 weeks follow up in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.
Time frame: 12 weeks after randomization
Blood pressure control (Cardiovascular secondary health metric component). Ideal (SBP <130 mmHg and DBP <90 mmHg). Intermediate (SBP 130-139 mmHg or DBP 80-89 mmHg). Poor (SBP ≥140 mmHg or DBP ≥90 mmHg).
Time frame: 12 weeks after randomization
Cholesterol (LDL-C) control (Cardiovascular secondary health metric component). Ideal (LDL-C <70mg/dL). Intermediate (LDL-C 70-99 mg/dL). Poor (LDL-C ≥100mg/dL)
Time frame: 12 weeks after randomization
Diabetes (HbA1c) control (Cardiovascular secondary health metric component). Ideal (HbA1c <7% for diabetic, <5.7% for non-diabetic). Intermediate (HbA1c 7.0-7.9% for diabetic, 5.0-5.9% for non-diabetic). Poor (HbA1c ≥8% for diabetic, ≥6.5% for non-diabetic).
Time frame: 12 weeks after randomization
Weight (BMI) categories (Cardiovascular secondary health metric component). Ideal (BMI <25 kg/m^2). Intermediate (BMI 25-29 kg/m^2). Poor (BMI ≥ 30 kg/m^2).
Time frame: 12 weeks after randomization
Physical activity categories (Cardiovascular secondary health metric component). Ideal (≥150 min/wk moderate physical activity, ≥75 min/wk vigorous physical activity). Intermediate (1-149 min/wk moderate physical activity, 1-74 min/wk vigorous physical activity). Poor (No regular exercise).
Time frame: 12 weeks after randomization
Diet categories (Cardiovascular secondary health metric component). Ideal (Rate Your Plate score 64-81). Intermediate (Rate Your Plate score 46-63). Poor (Rate Your Plate score 27-45).
Time frame: 12 weeks after randomization
Tobacco use categories (Cardiovascular secondary health metric component). Ideal (never). Intermediate (Former smoker). Poor (Recent/Current smoker).
Time frame: 12 weeks after randomization
Cardiac rehabilitation engagement as measured by number of participants who attended the sessions per category. Grouped by Healthcare Effectiveness Data and Information Set (HEDIS) categories: Initiation (0-12 sessions attended), Engagement 1 (13-24 sessions attended), Engagement 2 (25-36 sessions attended).
Time frame: 12 weeks after randomization
The difference in depressive symptoms as measured by Patient Health Questionnaire 8 (PHQ 8): The 8 item questionnaire administered at 12 weeks with the following scoring system: Score range 0-24. A score of 10 or greater is considered major depression, 20 or more is severe major depression.
Note, as an exploratory outcome, only a subgroup of participants responded to this survey request.
Time frame: 12 weeks after randomization
The difference in anxiety level as measured by Generalized Anxiety Disorder 7 (GAD 7): The 7-item questionnaire administered at 12 weeks follow up with the following scoring system. Each item is assigned scores of 0, 1, 2, and 3 to the response categories. GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety.
Time frame: 12 weeks after randomization
The difference in stress level as measured by Perceived Stress Scale (PSS -10): The 10 item questionnaire administered at 12 weeks follow up. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Time frame: 12 weeks after randomization
The difference in Health Literacy as measured by The (e) Health Literacy Scale (eHEALS): The 8 item scale administered at 12 weeks follow up. Total scores of the eHEALS range from 8 to 40, with higher scores representing higher self-perceived (e) Health literacy.
Time frame: 12 weeks after randomization
The difference in patient activation as measured by Patient Activation Measure 10 (PAM 10): The 10-item five-point Likert scale for assessing patient activation at 12 weeks follow up, indicating whether the patient possesses the necessary knowledge, skills, and confidence needed for self-care. The total score reference range is from 0 to 100, where higher scores indicate greater patient activation and ability for self-care.
Time frame: 12 weeks after randomization
Number of interactions in the smartphone app per participant, collected via the Corrie Health Platform User Analytics at 12 weeks follow up (only assessed in intervention arm).
Johns Hopkins University
Other
Impact of a Mobile Technology Enabled Corrie Cardiac Rehabilitation Program on Functional Status and Cardiovascular Outcomes (mTECH-Rehab): A Randomized Controlled Trial
Acronym: mTECH-Rehab
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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