The TEACH (Texting After ACS Discharge) Pilot Randomized Trial

Sponsor
Sunnybrook Health Sciences Centre (Other)
Overall Status
Recruiting
CT.gov ID
NCT05628337
Collaborator
(none)
250
1
2
36.5
6.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Motivational texting
  • Other: Control
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Pilot randomized trial, prospective, single centre, study intervention (texting motivation messages vs. placebo control), follow-up with administrative database linkagePilot randomized trial, prospective, single centre, study intervention (texting motivation messages vs. placebo control), follow-up with administrative database linkage
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 16, 2022
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Texting intervention group

Subjects will receive specific health-related texts

Other: Motivational texting
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

Other: Control
Non-motivational text messages containing no specific health information

Outcome Measures

Primary Outcome Measures

  1. Physician visit [Within one year of initial hospital presentation]

    Visit to a primary care physician or cardiologist specialist

Secondary Outcome Measures

  1. Emergency Department presentation [Within one year of initial hospital presentation]

    Presentation to an ED for any cause

  2. Re-hospitalization [Within one year of initial hospital presentation]

    To assess the need to re-hospitalize patient due to CAD

  3. Medication compliance [Within one year of initial hospital presentation]

    Assessment of medication compliance related to CAD

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Patients > 18 years old

  2. Presentation or admission to Sunnybrook Hospital with diagnosis of Acute Coronary Syndrome (ACS)

  3. Access to a cellphone that can receive text messages

Exclusion Criteria:
  1. Inability to consent for study in English

  2. Inability to read or answer English texts

  3. Lack of cellphone with SMS capability

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N3M5

Sponsors and Collaborators

  • Sunnybrook Health Sciences Centre

Investigators

  • Principal Investigator: Dennis Ko, MD, Research Director

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT05628337
Other Study ID Numbers:
  • 3563
First Posted:
Nov 28, 2022
Last Update Posted:
Dec 21, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sunnybrook Health Sciences Centre
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 21, 2022