NCT05628337

Brief Summary

Although there have been substantial advances in the treatment of heart disease, heart attacks remain one of the leading causes of death and suffering around the world. Each year, more than 80,000 patients are hospitalized with heart attacks or related conditions in Canada. Even after discharge, patients are at high risk of having complications such that almost one in two patients after a heart attack will be readmitted to hospitals within the first year. Given the shortage of doctors and allied health care professionals, there is an emerging focus of digital health as a way to improve the care and outcomes after heart attacks. With more than 30 million cell phone users across Canada and almost all are already using text message services, the goal of this study is to conduct a pilot test using an innovative clinical trial design to see if the care and outlook of heart attack patients using mobile text messages can be improved.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
241

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 16, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 28, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

April 27, 2025

Status Verified

April 1, 2025

Enrollment Period

2 years

First QC Date

November 16, 2022

Last Update Submit

April 23, 2025

Conditions

Keywords

Mobile health

Outcome Measures

Primary Outcomes (1)

  • Physician visit

    Visit to a primary care physician or cardiologist specialist

    Within one month, 3 months, and 12 months of randomization

Secondary Outcomes (3)

  • Emergency Department presentation

    Within one month, 3 months, and 12 months of randomization

  • Re-hospitalization

    Within one month, 3 months, and 12 months of hospital discharge

  • Medication compliance

    Within one month, 3 months, and 12 months of hospital discharge

Study Arms (2)

Texting intervention group

EXPERIMENTAL

Subjects will receive specific health-related texts

Other: Motivational texting

Control group

PLACEBO COMPARATOR

Subjects will receive general text messages without health information

Other: Control

Interventions

Health related information relevant to a subject's diagnosis and ongoing treatment

Texting intervention group
ControlOTHER

Non-motivational text messages containing no specific health information

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Inability to consent for study in English
  • Inability to read or answer English texts
  • Lack of cellphone with SMS capability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

Related Publications (16)

  • 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.

    PMID: 27500157BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 19339721BACKGROUND
  • 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.

    PMID: 23301730BACKGROUND
  • 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.

    PMID: 24820131BACKGROUND
  • 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.

    PMID: 23547178BACKGROUND
  • 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.

    PMID: 25173539BACKGROUND
  • 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.

    PMID: 25712950BACKGROUND
  • 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.

    PMID: 31474119BACKGROUND
  • 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.

    PMID: 26831740BACKGROUND
  • 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.

    PMID: 28455948BACKGROUND
  • 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.

    PMID: 31673381BACKGROUND
  • 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.

    PMID: 26393848BACKGROUND
  • 14. Communications Monitoring Report 2018. 2019; https://crtc.gc.ca/pubs/cmr2018-en.pdf. Accessed November 1, 2019.15.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 26324719BACKGROUND

Related Links

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Dennis Ko, MD

    Research Director

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Pilot randomized trial, prospective, single centre, study intervention (texting motivation messages vs. placebo control), follow-up with administrative database linkage
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2022

First Posted

November 28, 2022

Study Start

June 16, 2022

Primary Completion

May 31, 2024

Study Completion

July 31, 2025

Last Updated

April 27, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations