Cardiovascular DiseaseTxt2PreventNCT02336919
The Use of Texting Messaging to Improve the Hospital-to-community Transition Period in Cardiovascular Disease Patients
A study testing Txt2Prevent in people with Cardiovascular Disease and Acute Coronary Syndrome, run by Simon Fraser University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cardiovascular Disease, Acute Coronary Syndrome
- What is being tested?
- Txt2Prevent
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Text Messaging to Improve the Hospital-community Transition and Prevent Readmission in Patients With Cardiovascular Disease (Txt2Prevent)
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.
Read the 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.
- Conditions
- Cardiovascular Disease, Acute Coronary Syndrome
- Being tested
- Txt2Prevent
- Keywords
- discharge, mHealth, telehealth, text messaging
- Medical subject headings
- Cardiovascular Diseases, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Txt2PreventBehavioural
A 60-day text messaging program called Txt2Prevent (see description in the arm description).
| Study group | Role | What they receive |
|---|---|---|
| Txt2Prevent | Experimental | 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. Receives: Behavioral: Txt2Prevent |
| Usual Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-management as measured by the Health Education Impact Questionnaire by Osborne et al.
Measured: Pre- and post-study period (0 and 60 days)
Secondary outcomes (4)
Medication Adherence as measured by the Morisky Medication Adherence Scale by Morisky et al.
Measured: Post-study period (60 days)
Health-related quality of life as measured by the EuroQoL 5D-5L by the EuroQoL group
Measured: Pre- and post-study period (0 and 60 days)
Hospital readmissions
Measured: Assessed at the end of the study (day 60)
Mortality
Measured: Assessed at the end of the study (day 60)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simon Fraser University
- Sponsor type
- University, hospital or other
- Collaborators
- Providence Health & Services, University of British Columbia, McMaster University, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Scott Lear, Simon Fraser University
- Investigators
- Scott Lear, PhD, Principal investigator, Simon Fraser University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336919
- Sponsor's protocol ID
- H14-02385
- Acronym
- Txt2Prevent
- Status last verified
- Apr 2017
- First submitted
- 8 Jan 2015
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 33988519Ross 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.
PubMed 28536088
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Text Messaging to Improve the Hospital-community Transition and Prevent Readmission in Patients With Cardiovascular Disease (Txt2Prevent)
- ClinicalTrials.gov ID
- NCT02336919
- Acronym / sponsor ID
- Txt2Prevent / H14-02385
- Conditions
- Cardiovascular Disease, Acute Coronary Syndrome
- Keywords
- discharge, mHealth, telehealth, text messaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Simon Fraser UniversityUniversity, hospital or other
- Collaborators
- Providence Health & Services, University of British Columbia, McMaster University, Canadian Institutes of Health Research (CIHR)
- Study start
- Apr 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 13 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Txt2Prevent | Experimental | Behavioral: Txt2PreventThe 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. |
| Usual Care | No intervention | –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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Txt2PreventA 60-day text messaging program called Txt2Prevent (see description in the arm description). | Behavioural | Txt2Prevent |
Primary outcome
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)
4 secondary outcomes
Medication Adherence as measured by the Morisky Medication Adherence Scale by Morisky et al.
Time frame: Post-study period (60 days)
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)
Hospital readmissions
Time frame: Assessed at the end of the study (day 60)
Mortality
Time frame: Assessed at the end of the study (day 60)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Derived from this study: PubMed 33988519Ross 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.
- Derived from this study: PubMed 28536088Ross 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Lear, PhD principal investigator
Simon Fraser University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Txt2Prevent in people with Cardiovascular Disease and Acute Coronary Syndrome, run by Simon Fraser University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02336919, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2017.