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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02336919
Other study ID # H14-02385
Secondary ID
Status Completed
Phase N/A
First received January 8, 2015
Last updated April 24, 2017
Start date April 2015
Est. completion date January 2017

Study information

Verified date April 2017
Source Simon Fraser University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Txt2Prevent
A 60-day text messaging program called Txt2Prevent (see description in the arm description).

Locations

Country Name City State
Canada St. Paul's Hospital Vancouver British Columbia

Sponsors (5)

Lead Sponsor Collaborator
Simon Fraser University Canadian Institutes of Health Research (CIHR), McMaster University, Providence Health & Services, University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Self-management as measured by the Health Education Impact Questionnaire by Osborne et al. Pre- and post-study period (0 and 60 days)
Secondary Medication Adherence as measured by the Morisky Medication Adherence Scale by Morisky et al. Post-study period (60 days)
Secondary Health-related quality of life as measured by the EuroQoL 5D-5L by the EuroQoL group Pre- and post-study period (0 and 60 days)
Secondary Hospital readmissions Assessed at the end of the study (day 60)
Secondary Mortality Assessed at the end of the study (day 60)
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