None listed
Conditions
Brief summary
The primary objective of the TEXTME-2 study is to determine the impact of a program of lifestyle focused text messages on multiple modifiable cardiovascular risk factors, in a population of high cardiovascular risk individuals who have been referred to outpatient cardiology services for chest pain but without documented coronary artery disease (i.e. primary prevention cohort). In addition, this study will look at the effect of such a program on quality of life, health literacy, medication adherence and depression/anxiety scores. TEXTME-2 builds on the work of TEXTME which is a randomised controlled trial that has demonstrated that lifestyle focused text messaging service compared to usual care in patients with coronary artery disease (i.e. secondary prevention cohort) resulted in reductions in LDLC, blood pressure, BMI, significant increases in physical activity, and a significant reduction in smoking. It is unknown whether the text-messaging prevention program will be effective in a primary prevention cohort. TEXTME-2 is a single blinded randomised controlled trial. Recruitment will occur over 12 months. The TEXTME-2 program will be delivered over 6 months. The study population will consist of patients referred to an outpatient cardiology clinic for chest pain within a 12 month period, at high cardiovascular risk WITHOUT documented coronary artery disease. The intervention group will receive text messages up to 4 times a week. Control participants will receive standard lifestyle change advice and medication care only. The primary outcome is percent change in the proportion of patients who have 3 or more uncontrolled modifiable risk factors (low density lipoprotein cholesterol, systolic blood pressure, body mass index, physical activity, and smoking status).
Interventions
The intervention group will receive a lifestyle-focused text message support program. This program will be in addition to standard care (standard lifestyle change advice and medical care as clinically indicated). Participants randomized to the intervention group will, in addition to standard care, receive text messages up to 4 times a week for 6 months, on different days and at different times between 0800 and 1800. Each text message will be less than 160 characters. Control participants will re
The intervention group will receive a lifestyle-focused text message support program. This program will be in addition to standard care (standard lifestyle change advice and medical care as clinically indicated). Participants randomized to the intervention group will, in addition to standard care, receive text messages up to 4 times a week for 6 months, on different days and at different times between 0800 and 1800. Each text message will be less than 160 characters. Control participants will receive standard lifestyle change advice and medical care only. Messages will be managed by a message management software, which sends text messages up to 4 times a week to arrive at random times of the day (between 0800 - 1800) and random days of the week. Messages will be drawn from a bank. The text-messaging bank will be developed for 5 modules: diet, physical activity, smoking, general cardiovascular health, and medication adherence. The message management program will select messages for each participant at random from the bank of messages across the 5 modules. The message bank will be refined from our existing message bank including in TEXTME (ACTRN12611000161921). Specifically, we will remove questions specific to a cohort with established cardiovascular disease, and add an additional module on medication adherence. Examples text messages include: “Did you exercise today?”, “The Heart Foundation recommends at least 30 minutes of exercise most days of the week”, “Is there at low fat option? Most products have low fat options. Check the markings on the back”. There will be some personalisation of text messages based on age, smoking status, sex, and physical disability. For example, only smokers will receive messages regarding smoking cessation, and patients with limited mobility will not be sent messages regarding strenuous activities such as jogging. At the conclusion of the text message program (6 months), participants will be administered a questionnaire that will include items that address the acceptability of text messages, number and identification of which messages were read, identification of which messages participants remembered, liked or disliked, what they did with messages (e.g. kept them or deleted them immediately), their perceived utility of the text message and their opinion regarding the intrusiveness, timing and content suitability of the text messages.
Sponsors
Prof Clara Chow
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Referred to an outpatient cardiology clinic for assessment of chest pain or have other symptoms leading to investigation for ischaemic heart disease AND 2. Framingham absolute cardiovascular risk calculation of 10% or greater
Exclusion criteria
1. No active mobile phone 2. Unable to understand English 3. Unable to provide informed consent 4. Documented coronary artery disease (documented prior myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention, or 50% or greater stenosis in at least 1 major epicardial vessel on invasive coronary angiography)
Outcome results
None listed