- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02336919
The Use of Texting Messaging to Improve the Hospital-to-community Transition Period in Cardiovascular Disease Patients (Txt2Prevent)
The Use of Text Messaging to Improve the Hospital-community Transition and Prevent Readmission in Patients With Cardiovascular Disease (Txt2Prevent)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V6Z 1Y6
- St. Paul's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Txt2Prevent
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.
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A 60-day text messaging program called Txt2Prevent (see description in the arm description).
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No Intervention: Usual Care
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
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Pre- and post-study period (0 and 60 days)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Medication Adherence as measured by the Morisky Medication Adherence Scale by Morisky et al.
Time Frame: Post-study period (60 days)
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Post-study period (60 days)
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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)
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Pre- and post-study period (0 and 60 days)
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Hospital readmissions
Time Frame: Assessed at the end of the study (day 60)
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Assessed at the end of the study (day 60)
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Mortality
Time Frame: Assessed at the end of the study (day 60)
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Assessed at the end of the study (day 60)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Scott Lear, PhD, Simon Fraser University
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
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
- H14-02385
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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