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The Use of Texting Messaging to Improve the Hospital-to-community Transition Period in Cardiovascular Disease Patients (Txt2Prevent)

Primary Purpose

Cardiovascular Disease, Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Txt2Prevent
Sponsored by
Simon Fraser University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cardiovascular Disease focused on measuring discharge, mHealth, telehealth, text messaging

Eligibility Criteria

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

Inclusion Criteria:

  • are an acute coronary syndrome patient on the non-surgical ward who will be discharged home
  • own a phone with text-messaging capabilities and have the ability to access new text messages
  • have the ability to provide informed consent
  • have the ability to read and understand English

Exclusion Criteria:

  • have a pre-scheduled surgical procedure within the duration of the study
  • if it is expected that they will not survive the duration of the study due to non-cardiovascular reasons
  • are currently enrolled in another research project regarding CVDs that would interfere with the study outcomes.

Sites / Locations

  • St. Paul's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Txt2Prevent

Usual Care

Arm Description

The treatment group will receive all the usual discharge treatment, instructions and information for acute coronary syndrome patients as well as the Txt2Prevent text-messaging program. The program will include a variety of topics such as standard follow-up care reminders as well as general self-management and healthy living texts. There will be two streams, one for current/recent smokers and one for non-smokers. Texts will be sent out every 1-3 days for 60 days. All participants in the same stream will receive the same texts in the same order.

The usual care group will receive all standard discharge treatment, instructions and information for patients with acute coronary syndrome, but no text-messaging program. Nurses typically go over important information with patients before they leave as well as give them printed materials.

Outcomes

Primary Outcome Measures

Self-management as measured by the Health Education Impact Questionnaire by Osborne et al.

Secondary Outcome Measures

Medication Adherence as measured by the Morisky Medication Adherence Scale by Morisky et al.
Health-related quality of life as measured by the EuroQoL 5D-5L by the EuroQoL group
Hospital readmissions
Mortality

Full Information

First Posted
January 8, 2015
Last Updated
April 24, 2017
Sponsor
Simon Fraser University
Collaborators
Providence Health & Services, University of British Columbia, McMaster University, Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT02336919
Brief Title
The Use of Texting Messaging to Improve the Hospital-to-community Transition Period in Cardiovascular Disease Patients
Acronym
Txt2Prevent
Official Title
The Use of Text Messaging to Improve the Hospital-community Transition and Prevent Readmission in Patients With Cardiovascular Disease (Txt2Prevent)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Simon Fraser University
Collaborators
Providence Health & Services, University of British Columbia, McMaster University, Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Participants will be recruited during their hospitalization for either heart attack or unstable angina and will be randomly assigned to either a text message program (Txt2Prevent) or usual care. They will be texted for the first 60-days after discharge. Texts will include topics regarding self-management and discharge protocols such as reminders to make an appointment with their general practitioner or to refill medication prescriptions. After 60 days, the two groups will be compared for hospital readmission rates, quality of life, medication adherence, and self-management.
Detailed Description
Cardiovascular disease is one of the leading causes for hospitalization and death in Canada. Being discharged is often a challenging and overwhelming time. Sometimes patients are readmitted to the hospital shortly in the months following their discharge. Some of these readmissions are due to information transfer being poor or insufficient. Previous studies have looked at whether text messaging can be a simple, cost-effective way to help patients. Therefore, we wish to investigate the effectiveness of using text messaging to help heart patients after they are discharged from the hospital. The goal of this study is to determine the impact of a pilot text-messaging intervention program (Txt2Prevent) that supports coronary syndrome (heart attack and unstable angina) patients for 60 days after their hospital discharge. The program will include information about follow-up care, medication use, and healthy lifestyle behaviours. The texts will be sent at relevant times during the patients' recovery. The primary objective is compare self-management between the usual care patients versus the Txt2prevent patients. We hypothesize that the Txt2Prevent group will have better self-management than the usual care group. The secondary objective is compare medication adherence, and health-related quality of life as well as readmission and mortality rates between the two patient groups. We hypothesize that the Txt2Prevent group will have better outcomes for these variables. The study population is acute coronary syndrome patients at St. Paul's hospital who are discharged. Participants will be randomly assigned to one of two groups-a usual care group and the usual care plus the Txt2Prevent text messaging program group. All participants will undergo a baseline assessment that includes: Demographics, medical history, medication use and technology use information Self-management skills Health-related quality of life After 60 days, participants will be contacted again to perform a follow up assessment that includes: Information on readmission, medication use, the use of health services such as cardiac rehab Self-management skills Health-related quality of life Medication adherence In both the baseline and follow-up assessments, information may be obtained from the patient's medical chart or records (e.g. medical history) or self-report. After the intervention, some intervention participants will be contacted to complete a semi-structured interview about their experiences with the Txt2Prevent program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Acute Coronary Syndrome
Keywords
discharge, mHealth, telehealth, text messaging

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Txt2Prevent
Arm Type
Experimental
Arm Description
The treatment group will receive all the usual discharge treatment, instructions and information for acute coronary syndrome patients as well as the Txt2Prevent text-messaging program. The program will include a variety of topics such as standard follow-up care reminders as well as general self-management and healthy living texts. There will be two streams, one for current/recent smokers and one for non-smokers. Texts will be sent out every 1-3 days for 60 days. All participants in the same stream will receive the same texts in the same order.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
The usual care group will receive all standard discharge treatment, instructions and information for patients with acute coronary syndrome, but no text-messaging program. Nurses typically go over important information with patients before they leave as well as give them printed materials.
Intervention Type
Behavioral
Intervention Name(s)
Txt2Prevent
Intervention Description
A 60-day text messaging program called Txt2Prevent (see description in the arm description).
Primary Outcome Measure Information:
Title
Self-management as measured by the Health Education Impact Questionnaire by Osborne et al.
Time Frame
Pre- and post-study period (0 and 60 days)
Secondary Outcome Measure Information:
Title
Medication Adherence as measured by the Morisky Medication Adherence Scale by Morisky et al.
Time Frame
Post-study period (60 days)
Title
Health-related quality of life as measured by the EuroQoL 5D-5L by the EuroQoL group
Time Frame
Pre- and post-study period (0 and 60 days)
Title
Hospital readmissions
Time Frame
Assessed at the end of the study (day 60)
Title
Mortality
Time Frame
Assessed at the end of the study (day 60)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: are an acute coronary syndrome patient on the non-surgical ward who will be discharged home own a phone with text-messaging capabilities and have the ability to access new text messages have the ability to provide informed consent have the ability to read and understand English Exclusion Criteria: have a pre-scheduled surgical procedure within the duration of the study if it is expected that they will not survive the duration of the study due to non-cardiovascular reasons are currently enrolled in another research project regarding CVDs that would interfere with the study outcomes.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Lear, PhD
Organizational Affiliation
Simon Fraser University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33988519
Citation
Ross ES, Sakakibara BM, Mackay MH, Whitehurst DGT, Singer J, Toma M, Corbett KK, Van Spall HGC, Rutherford K, Gheorghiu B, Code J, Lear SA. The Use of SMS Text Messaging to Improve the Hospital-to-Community Transition in Patients With Acute Coronary Syndrome (Txt2Prevent): Results From a Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 May 14;9(5):e24530. doi: 10.2196/24530.
Results Reference
derived
PubMed Identifier
28536088
Citation
Ross ES, Sakakibara BM, Mackay MH, Whitehurst DG, Singer J, Toma M, Corbett KK, Van Spall HG, Rutherford K, Gheorghiu B, Code J, Lear SA. The Use of Text Messaging to Improve the Hospital-to-Community Transition in Acute Coronary Syndrome Patients (Txt2Prevent): Intervention Development and Pilot Randomized Controlled Trial Protocol. JMIR Res Protoc. 2017 May 23;6(5):e91. doi: 10.2196/resprot.6968.
Results Reference
derived

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The Use of Texting Messaging to Improve the Hospital-to-community Transition Period in Cardiovascular Disease Patients

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