Clinical trial NCT02336919: The Use of Texting Messaging to Improve the Hospital-to-community Transition Period in Cardiovascular Disease Patients
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
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Acute Coronary Syndrome
Keywords: discharge
mHealth
telehealth
text messaging
Lead sponsor: Simon Fraser University
Sponsor class: OTHER
Collaborators: name: Providence Health & Services
name: University of British Columbia
name: McMaster University
name: Canadian Institutes of Health Research (CIHR)
First posted: 2015-01-13
Enrollment: 76
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Self-management as measured by the Health Education Impact Questionnaire by Osborne et al.
timeFrame: Pre- and post-study period (0 and 60 days)
Secondary outcomes:
measure: Medication Adherence as measured by the Morisky Medication Adherence Scale by Morisky et al.
timeFrame: Post-study period (60 days)
measure: Health-related quality of life as measured by the EuroQoL 5D-5L by the EuroQoL group
timeFrame: Pre- and post-study period (0 and 60 days)
measure: Hospital readmissions
timeFrame: Assessed at the end of the study (day 60)
measure: Mortality
timeFrame: Assessed at the end of the study (day 60)
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
Study officials:
affiliation: Simon Fraser University
name: Scott Lear, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.