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Impact of a Corrie Cardiac Rehabilitation Program (mTECH-Rehab)

Abgeschlossen
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT05238103 (mTECH-Rehab) untersuchte Koronararterienerkrankung, Myokardinfarkt, Myokardischämie, Koronararterienverschluss, Coronary Artery Stenosis Stent, Bypass-Transplantatverschluss, Herzklappenerkrankung als interventionsstudie und hat den Status abgeschlossen. Die Studie begann am 3. April 2023 mit 259 Teilnehmern. Sie wurde durchgeführt von Johns Hopkins University und am 14. Oktober 2024 abgeschlossen. Die Daten von ClinicalTrials.gov wurden zuletzt am 5. Dezember 2025 aktualisiert.
Kurzbeschreibung
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.
Offizieller Titel

Impact of a Mobile Technology Enabled Corrie Cardiac Rehabilitation Program on Functional Status and Cardiovascular Outcomes (mTECH-Rehab): A Randomized Controlled Trial

Erkrankungen
KoronararterienerkrankungMyokardinfarktMyokardischämieKoronararterienverschlussCoronary Artery Stenosis StentBypass-TransplantatverschlussHerzklappenerkrankung
Publikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:
Weitere Studien-IDs
  • mTECH-Rehab
  • IRB00308410
NCT-Nummer
NCT05238103
Studienbeginn (tatsächlich)
2023-04-03
Zuletzt aktualisiert
2025-12-05
Studienende (vorauss.)
2024-10-14
Geplante Rekrutierung
259
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Abgeschlossen
Stichwörter
digital health
smartphone app
self-management
guideline adherence
behavior modification
community engagement
Primäres Ziel
Supportivtherapie
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Einfach verblindet
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellCorrie Hybrid Cardiac Rehabilitation Program (Intervention Group)
Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.
Corrie Hybrid Cardiac Rehabilitation Program
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.
Keine InterventionFacilitated Center-Based Cardiac Rehabilitation Program (Control Group)
Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.
Nicht zutreffend
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
6-minute Walking Distance (Meters)
Mean difference in 6 minute walk distance, between Intervention and Control groups, as measured at final study visit occurring at 12 weeks after randomization.
12 weeks after randomization
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Composite Cardiovascular Health Metric for Secondary Prevention
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.
12 weeks after randomization
Blood Pressure (mmHg)
Systolic blood pressure and Diastolic blood pressure
12 weeks after randomization
Low Density Lipoprotein - Cholesterol (LDL-C)
LDL cholesterol level (in mg/dl) measured through blood sample drawn at 12 week follow up visit
12 weeks after randomization
Glycosylated Hemoglobin (HbA1c)
Glycosylated hemoglobin (HbA1c) level (%) measured through blood sample drawn at 12 week follow up visit
12 weeks after randomization
Body Mass Index (kg/m^2)
BMI = weight (kg) / height in meters squared (m\^2). Weight and height measured by study staff at study visit.
12 weeks after randomization
Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10
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.
12 weeks after randomization
Blood Pressure Control
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).
12 weeks after randomization
Cholesterol (LDL-C) Control
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)
12 weeks after randomization
Diabetes Control
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).
12 weeks after randomization
Weight (BMI) Categories
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).
12 weeks after randomization
Physical Activity Categories
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).
12 weeks after randomization
Diet Categories
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).
12 weeks after randomization
Tobacco Use
Tobacco use categories (Cardiovascular secondary health metric component). Ideal (never). Intermediate (Former smoker). Poor (Recent/Current smoker).
12 weeks after randomization
Cardiac Rehabilitation Engagement
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).
12 weeks after randomization
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
  • 18 years or older
  • Individuals admitted to the hospital for the following conditions or interventions during the index admission: Acute myocardial infarction (STEMI or NSTEMI type 1), Coronary artery bypass grafting (CABG), and Coronary artery angioplasty/stenting (PCI), Heart valve surgery, catheter-based aortic valve replacement (TAVR).

  • Non-English speaking

  • Symptomatic severe aortic stenosis or other severe valvular disease

  • Physical disability that would preclude safe and adequate exercise performance

  • Hypertrophic obstructive cardiomyopathy with peak resting left ventricular outflow gradient of >25 mmHg

  • Known aortic dissection

  • Severe resting arterial hypertension (Systolic blood pressure >200 mmHg or diastolic BP >110mmHg) at baseline assessment

  • Mental impairment leading to inability to cooperate with study procedures

  • Untreated high degree atrioventricular block

  • Atrial fibrillation with uncontrolled ventricular rate (Heart rate >110 at rest) at baseline assessment

  • History of cardiac arrest or sudden death

  • Myocardial infarction or cardiac surgery complications with cardiogenic shock and/or congestive heart failure and/or signs/symptoms of post-procedure ischemia

  • Left ventricular ejection fraction <40%

  • History of Clinically significant depression

  • Visual or hearing impairment which precludes the use of the intervention

  • Presence of cardiac defibrillator

  • Incomplete revascularization procedure

  • History of one or more episodes of falls in the last year

  • Pregnancy

    • If patients are deemed clinically unstable and unable to participate at the time of initial screening, the research team member may return at a later date to determine whether this status has changed.
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Johns Hopkins University, Baltimore, Maryland, 21287, United States