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The TEACH (Texting After ACS Discharge) Pilot Randomized Trial

Primary Purpose

Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Motivational texting
Control
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Mobile health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sunnybrook Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Texting intervention group

Control group

Arm Description

Subjects will receive specific health-related texts

Subjects will receive general text messages without health information

Outcomes

Primary Outcome Measures

Physician visit
Visit to a primary care physician or cardiologist specialist

Secondary Outcome Measures

Emergency Department presentation
Presentation to an ED for any cause
Re-hospitalization
To assess the need to re-hospitalize patient due to CAD
Medication compliance
Assessment of medication compliance related to CAD

Full Information

First Posted
November 16, 2022
Last Updated
October 12, 2023
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT05628337
Brief Title
The TEACH (Texting After ACS Discharge) Pilot Randomized Trial
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Mobile health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pilot randomized trial, prospective, single centre, study intervention (texting motivation messages vs. placebo control), follow-up with administrative database linkage
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Texting intervention group
Arm Type
Experimental
Arm Description
Subjects will receive specific health-related texts
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Subjects will receive general text messages without health information
Intervention Type
Other
Intervention Name(s)
Motivational texting
Intervention Description
Health related information relevant to a subject's diagnosis and ongoing treatment
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Non-motivational text messages containing no specific health information
Primary Outcome Measure Information:
Title
Physician visit
Description
Visit to a primary care physician or cardiologist specialist
Time Frame
Within one month, 3 months, and 12 months of randomization
Secondary Outcome Measure Information:
Title
Emergency Department presentation
Description
Presentation to an ED for any cause
Time Frame
Within one month, 3 months, and 12 months of randomization
Title
Re-hospitalization
Description
To assess the need to re-hospitalize patient due to CAD
Time Frame
Within one month, 3 months, and 12 months of hospital discharge
Title
Medication compliance
Description
Assessment of medication compliance related to CAD
Time Frame
Within one month, 3 months, and 12 months of hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sulagna Sarker
Phone
416 480 6100
Email
sulagna.sarker@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Ko, MD
Organizational Affiliation
Research Director
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sulagna Sarker
Phone
416 480 6100
Email
sulagna.sarker@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Dennis Ko, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27500157
Citation
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23547178
Citation
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Citation
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PubMed Identifier
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Citation
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Citation
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Citation
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Results Reference
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Links:
URL
https://crtc.gc.ca/pubs/cmr2018-en.pdf
Description
Communications Monitoring Report 2018. 2019

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The TEACH (Texting After ACS Discharge) Pilot Randomized Trial

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