- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05628337
The TEACH (Texting After ACS Discharge) Pilot Randomized Trial
Effects of Mobile Text Intervention on Transitions of Care and Outcomes After Hospitalization With Acute Coronary Syndrome - The TEACH (Texting After ACS Discharge) Pilot Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The healthcare system is in desperate need of novel strategies to better engage with cardiac patients to improve care and how patients interact with the healthcare system. Although almost everyone has a mobile phone in Canada, healthcare systems have not sufficiently explored mobile health strategies that can improve health. Yet, a recent survey suggests that alternative access to healthcare is highly desirable by Canadians. Adoption of mobile health technologies has the potential to add an additional avenue for how the healthcare system can interact with patients. Most importantly, these strategies are already used by many other industries and thus can be easily implementable and expandable in healthcare institutions across the country.
Due to the COVID-19 pandemic, it has become evident that the way healthcare is delivered in the future will be different than it has been for many decades. With the conversion of many forms of care to virtual and online platforms, mobile-based care could become an important component of cardiac care. Thus, this project will help to explore the use of mobile-based virtual care platforms in cardiac follow-up in the ACS populations.
The main goal of the study is to test the feasibility and potential effects of mobile text message-based intervention on transitions of care after hospitalization with heart attack.
The hypotheses are that i) the majority of patients will be willing to participate in the pilot study and continue to receive text messages during the study, ii) the group that receives texting will have more frequent physician visits and take medication more consistently at 1 year after discharge, iii) the group that receives texting will have lower rates of readmission at 1 year after discharge.
One of the most innovative aspects of this study is the ability to conduct an intervention of mobile technology and follow-up outcomes of patients using existing registries and data that are routinely collected in day-to-day care. Accordingly, this study will be conducted at a fraction of the cost compared to a traditional randomized design. It also means that the study concept could be easily replicated in many different areas of medicine.
The main goal of the study is to test the feasibility of mobile text message-based interventions on transitions of care after hospitalization with a heart attack.
Medication compliance, re-hospitalization, and Emergency Department presentation will be tracked. These outcomes will be measured using ICES database linking patient health care number, to determine hospital admissions, ER presentations, and prescription filling.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N3M5
- Sunnybrook Health Sciences Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients > 18 years old
- Presentation or admission to Sunnybrook Hospital with diagnosis of Acute Coronary Syndrome (ACS)
- Access to a cellphone that can receive text messages
Exclusion Criteria:
- Inability to consent for study in English
- Inability to read or answer English texts
- Lack of cellphone with SMS capability
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Texting intervention group
Subjects will receive specific health-related texts
|
Health related information relevant to a subject's diagnosis and ongoing treatment
|
|
Placebo Comparator: Control group
Subjects will receive general text messages without health information
|
Non-motivational text messages containing no specific health information
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physician visit
Time Frame: Within one month, 3 months, and 12 months of randomization
|
Visit to a primary care physician or cardiologist specialist
|
Within one month, 3 months, and 12 months of randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emergency Department presentation
Time Frame: Within one month, 3 months, and 12 months of randomization
|
Presentation to an ED for any cause
|
Within one month, 3 months, and 12 months of randomization
|
|
Re-hospitalization
Time Frame: Within one month, 3 months, and 12 months of hospital discharge
|
To assess the need to re-hospitalize patient due to CAD
|
Within one month, 3 months, and 12 months of hospital discharge
|
|
Medication compliance
Time Frame: Within one month, 3 months, and 12 months of hospital discharge
|
Assessment of medication compliance related to CAD
|
Within one month, 3 months, and 12 months of hospital discharge
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dennis Ko, MD, Research Director
Publications and helpful links
General Publications
- Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009 Apr 2;360(14):1418-28. doi: 10.1056/NEJMsa0803563. Erratum In: N Engl J Med. 2011 Apr 21;364(16):1582.
- Sanchis-Gomar F, Perez-Quilis C, Leischik R, Lucia A. Epidemiology of coronary heart disease and acute coronary syndrome. Ann Transl Med. 2016 Jul;4(13):256. doi: 10.21037/atm.2016.06.33.
- 2. Canadian Institute for Health Information. CIHI Data Quality Study of Ontario Emergency Department Visits 2004-2005: Volume II of IV - Main Study Findings Ottawa, Ontario 2008.3.
- Krumholz HM. Post-hospital syndrome--an acquired, transient condition of generalized risk. N Engl J Med. 2013 Jan 10;368(2):100-2. doi: 10.1056/NEJMp1212324. No abstract available.
- Leppin AL, Gionfriddo MR, Kessler M, Brito JP, Mair FS, Gallacher K, Wang Z, Erwin PJ, Sylvester T, Boehmer K, Ting HH, Murad MH, Shippee ND, Montori VM. Preventing 30-day hospital readmissions: a systematic review and meta-analysis of randomized trials. JAMA Intern Med. 2014 Jul;174(7):1095-107. doi: 10.1001/jamainternmed.2014.1608.
- Czarnecki A, Chong A, Lee DS, Schull MJ, Tu JV, Lau C, Farkouh ME, Ko DT. Association between physician follow-up and outcomes of care after chest pain assessment in high-risk patients. Circulation. 2013 Apr 2;127(13):1386-94. doi: 10.1161/CIRCULATIONAHA.112.000737.
- Czarnecki A, Wang JT, Tu JV, Lee DS, Schull MJ, Lau C, Farkouh ME, Wijeysundera HC, Ko DT. The role of primary care physician and cardiologist follow-up for low-risk patients with chest pain after emergency department assessment. Am Heart J. 2014 Sep;168(3):289-95. doi: 10.1016/j.ahj.2014.05.016. Epub 2014 Jun 9.
- Wong MK, Wang JT, Czarnecki A, Koh M, Tu JV, Schull MJ, Wijeysundera HC, Lau C, Ko DT. Factors associated with physician follow-up among patients with chest pain discharged from the emergency department. CMAJ. 2015 Mar 17;187(5):E160-8. doi: 10.1503/cmaj.141294. Epub 2015 Feb 23.
- Huo X, Krumholz HM, Bai X, Spatz ES, Ding Q, Horak P, Zhao W, Gong Q, Zhang H, Yan X, Sun Y, Liu J, Wu X, Guan W, Wang X, Li J, Li X, Spertus JA, Masoudi FA, Zheng X. Effects of Mobile Text Messaging on Glycemic Control in Patients With Coronary Heart Disease and Diabetes Mellitus: A Randomized Clinical Trial. Circ Cardiovasc Qual Outcomes. 2019 Sep;12(9):e005805. doi: 10.1161/CIRCOUTCOMES.119.005805. Epub 2019 Aug 31.
- Thakkar J, Kurup R, Laba TL, Santo K, Thiagalingam A, Rodgers A, Woodward M, Redfern J, Chow CK. Mobile Telephone Text Messaging for Medication Adherence in Chronic Disease: A Meta-analysis. JAMA Intern Med. 2016 Mar;176(3):340-9. doi: 10.1001/jamainternmed.2015.7667.
- Adler AJ, Martin N, Mariani J, Tajer CD, Owolabi OO, Free C, Serrano NC, Casas JP, Perel P. Mobile phone text messaging to improve medication adherence in secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2017 Apr 29;4(4):CD011851. doi: 10.1002/14651858.CD011851.pub2.
- Shariful Islam SM, Farmer AJ, Bobrow K, Maddison R, Whittaker R, Pfaeffli Dale LA, Lechner A, Lear S, Eapen Z, Niessen LW, Santo K, Stepien S, Redfern J, Rodgers A, Chow CK. Mobile phone text-messaging interventions aimed to prevent cardiovascular diseases (Text2PreventCVD): systematic review and individual patient data meta-analysis. Open Heart. 2019 Oct 9;6(2):e001017. doi: 10.1136/openhrt-2019-001017. eCollection 2019.
- 14. Communications Monitoring Report 2018. 2019; https://crtc.gc.ca/pubs/cmr2018-en.pdf. Accessed November 1, 2019.15.
- Tu JV, Chu A, Rezai MR, Guo H, Maclagan LC, Austin PC, Booth GL, Manuel DG, Chiu M, Ko DT, Lee DS, Shah BR, Donovan LR, Sohail QZ, Alter DA. The Incidence of Major Cardiovascular Events in Immigrants to Ontario, Canada: The CANHEART Immigrant Study. Circulation. 2015 Oct 20;132(16):1549-1559. doi: 10.1161/CIRCULATIONAHA.115.015345. Epub 2015 Aug 31.
- 15. Lauer MS, D'Agostino RB, Sr. The randomized registry trial--the next disruptive technology in clinical research? N Engl J Med. 2013;369(17):1579-1581.16. Ko DT, Alter DA, Guo H, et al. High-Density Lipoprotein Cholesterol and Cause-Specific Mortality in Individuals Without Previous Cardiovascular Conditions: The CANHEART Study. J Am Coll Cardiol. 2016;68(19):2073-2083.17.
- Chow CK, Redfern J, Hillis GS, Thakkar J, Santo K, Hackett ML, Jan S, Graves N, de Keizer L, Barry T, Bompoint S, Stepien S, Whittaker R, Rodgers A, Thiagalingam A. Effect of Lifestyle-Focused Text Messaging on Risk Factor Modification in Patients With Coronary Heart Disease: A Randomized Clinical Trial. JAMA. 2015 Sep 22-29;314(12):1255-63. doi: 10.1001/jama.2015.10945. Erratum In: JAMA. 2016 Mar 8;315(10):1057. doi: 10.1001/jama.2016.0809.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3563
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Artery Disease
-
Infirmerie Protestante de LyonRecruitingCoronary Artery Bypass | Coronary Artery Disease(CAD) | Off Pump Coronary Artery Bypass Surgery | Hemodynamic Optimization | Hemodynamic Management | Off Pump Coronary Artery Bypass Graft | Coronary Artery Disease With Need for Bypass Surgery | NoradrenalineFrance
-
Shanghai Bluesail Boyuan Medical Technology Co....Not yet recruitingCoronary Artery Disease | Coronary Artery Calcification | Severe Coronary Artery DiseaseChina
-
Scitech Produtos Medicos SANot yet recruitingCoronary Artery Disease (CAD) | Multivessel Coronary Artery Disease | Complex Coronary Lesions | Calcific Coronary Arteriosclerosis | Small Vessel Ischemic Disease | Stenosis CoronaryBrazil
-
Istanbul Mehmet Akif Ersoy Educational and Training...Bakirkoy Dr. Sadi Konuk Research and Training Hospital; Ege University; Istanbul... and other collaboratorsActive, not recruitingCoronary Artery Disease (CAD) | Coronary Bifurcation Lesion | Left Main Coronary Artery StenosisTurkey (Türkiye)
-
I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioCompletedCoronary Artery Disease (CAD) | Atherosclerosis of Coronary ArteryItaly
-
EBI Anti Sepsis BVCR2O B.V.Not yet recruitingCoronary Artery Disease (CAD) | Coronary Artery Bypass Graft Surgery(CABG)United States, Netherlands, Belgium, United Kingdom
-
Elixir Medical CorporationIstituto Clinico HumanitasActive, not recruitingCoronary Artery Disease | Chronic Total Occlusion of Coronary Artery | Multi Vessel Coronary Artery Disease | Bifurcation of Coronary Artery | Long Lesions Coronary Artery DiseaseItaly
-
University Medical Centre LjubljanaRecruitingCoronary Artery Disease With Myocardial InfarctionSlovenia
-
Shunmei MedicalNot yet recruitingCalcified Coronary Artery Disease | Coronary Arterial DiseasePoland, France, Spain
-
OPCI Core Laboratories LLCNot yet recruitingCoronary Artery Disease (CAD) | Coronary Calcification | Coronary Calcified Disease | Coronary Calcified NodulesUnited States
Clinical Trials on Motivational texting
-
St. Louis UniversityCompletedSMS | Education, Medical, UndergraduateUnited States
-
University of MichiganNational Institute of Mental Health (NIMH)Completed
-
University of PennsylvaniaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedEarly Pregnancy | Early Pregnancy LossUnited States
-
University of Colorado, DenverCompletedType 1 Diabetes MellitusUnited States
-
Northwestern UniversityCompletedGestational Diabetes | Pregnancy in Diabetics
-
General Committee of Teaching Hospitals and Institutes...King Saud UniversityCompletedMuscle Weakness Condition | Hand GraspSaudi Arabia
-
Children's Hospital of PhiladelphiaUniversity of Pennsylvania; Leonard Davis Institute of Health EconomicsCompletedParent-Child Relations | Parenting | LiteracyUnited States
-
University of Illinois at Urbana-ChampaignUniversity of Minnesota; The University of The West IndiesCompleted
-
University of WashingtonCompleted