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Trial registered on ANZCTR


Registration number
ACTRN12618001153202
Ethics application status
Approved
Date submitted
27/06/2018
Date registered
12/07/2018
Date last updated
16/05/2019
Date data sharing statement initially provided
16/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Tobacco, EXercise, and DieT MEssages for primary prevention of cardiovascular disease in those who are at high risk (TEXTME-2): A mobile health primary prevention program
Scientific title
Tobacco, EXercise, and DieT MEssages for primary prevention of cardiovascular disease (TEXTME-2): A mobile Health primary prevention program
Secondary ID [1] 292354 0
None
Universal Trial Number (UTN)
U1111-1198-7663
Trial acronym
TEXTME-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients at high risk of cardiovascular events who do not have documented coronary heart disease 303905 0
Condition category
Condition code
Cardiovascular 303269 303269 0 0
Hypertension
Metabolic and Endocrine 307627 307627 0 0
Diabetes
Cardiovascular 307628 307628 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 298530 0
Prevention
Intervention code [2] 298531 0
Treatment: Other
Intervention code [3] 298532 0
Lifestyle
Comparator / control treatment
Control participants will receive "usual care" only. This includes standard lifestyle change advice and medical care as directed by the patients' treating doctor/s.
Control group
Active

Outcomes
Primary outcome [1] 302647 0
Difference between groups in the proportion of patients who have 3 or more uncontrolled modifiable risk factors (composite of Low density lipoprotein cholesterol (LDL-C); systolic blood pressure; body mass index (BMI); physical activity; smoking status).

Control of modifiable risk factors is defined as: LDL-C <2 mmol/L, Blood pressure <140/90 mmHg, Exercising regularly, Nonsmoker, BMI <25. This will be measured in the following manner:
1. LDL cholesterol – fasting blood sample
2. Systolic Blood pressure (BP) – 3 digital recordings of resting, sitting BP, mean of last 2
readings (using office automated BP)
3. Physical activity – Global Physical Activity Questionnaire (GPAQ)
4. Smoking rate, quit attempts – self report
5. BMI - weight/height*2– measured by research assistant blinded to treatment allocation
Timepoint [1] 302647 0
Baseline and 6 months
Secondary outcome [1] 336632 0
Low density lipoprotein cholesterol measured by fasting blood sample
Timepoint [1] 336632 0
Baseline and 6 months
Secondary outcome [2] 336633 0
Systolic blood pressure measured by sitting digital recording (average of 3 readings)
Timepoint [2] 336633 0
Baseline and 6 months
Secondary outcome [3] 336634 0
Body mass index and waist circumference measured by digital scales and tape measure according to national standards
Timepoint [3] 336634 0
Baseline and 6 months
Secondary outcome [4] 336635 0
HbA1c (glycosylated haemoglobin) for those who have diabetes mellitus
Timepoint [4] 336635 0
Baseline and 6 months
Secondary outcome [5] 336636 0
Level of physical activity as assessed by Global Physical Activity Questionnaire (GPAQ)
Timepoint [5] 336636 0
Baseline and 6 months
Secondary outcome [6] 336637 0
Self-reported smoking rate (cigarettes per day) and quit attempts for those who were identified as smokers
Timepoint [6] 336637 0
Baseline and 6 months
Secondary outcome [7] 336638 0
Servings of vegetables and fruit consumed each day (self-reported) over the last 7 days
Timepoint [7] 336638 0
Baseline and 6 months
Secondary outcome [8] 336639 0
Quality of life as assessed by the EQ-5D-5L Health Survey
Timepoint [8] 336639 0
6 months only
Secondary outcome [9] 336640 0
Depression and anxiety levels as assessed by Patient Health Questionnaire- 9 (PHQ-9)
Timepoint [9] 336640 0
6 months only
Secondary outcome [10] 336641 0
Health literacy as measured by BRIEF questionnaire for general health literacy. Mean score will be used.
Timepoint [10] 336641 0
Baseline only
Secondary outcome [11] 336642 0
Medication adherence. Self-report of use over last 7 and 30 days
Timepoint [11] 336642 0
Baseline and 6 months
Secondary outcome [12] 336643 0
Hospital presentations and readmissions. Self report, hospital records.
Timepoint [12] 336643 0
6 months only
Secondary outcome [13] 349002 0
Generalised Anxiety Disorder 7-item (GAD-7) score
Timepoint [13] 349002 0
6 months only
Secondary outcome [14] 349003 0
Cardiovascular Knowledge Survey. Mean score will be used.
Timepoint [14] 349003 0
6 months only
Secondary outcome [15] 349004 0
Use of community health services (GP, specialists – self report)
Timepoint [15] 349004 0
6 months only
Secondary outcome [16] 349005 0
Cardiovascular death
Timepoint [16] 349005 0
6 months only

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be approached directly by the researcher during a brief face to face meeting during their outpatient clinic appointment. The researcher will establish whether the patient is interested in participating and if they consent they will be randomised.
The patients will be allocated by central randomisation by computer and the research staff will not be aware of treatment allocation. To maintain blinding of study personnel, patients will be informed of their allocation in a text message sent after leaving the outpatient cardiology clinic. Prior to any follow-up appointments patients will also receive a text message to ask them not to reveal their allocation status to study personnel or clinicians.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible participants will be randomised into either the treatment arm (texting program) or standard care. Randomisation will occur via a computerised randomisation program that will be accessed through a secure web interface that will be accessible by study staff with username and password. The random allocation sequence will be in a uniform 1:1 allocation ratio with variable block size and will be concealed from study personnel.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Based on our current referrals of high-risk patients without documented CAD, and assuming 10% loss to follow-up rate, our estimated possible sample size would be 246. Using existing local control data we found that 62% of a primary prevention cohort attending an outpatient cardiology clinic had 3 or more risk factors. We estimated that with 90% power and two-sided a at 0.05, a sample size of 246 (123 in each group) would be able to detect a 33% decrease in the proportion of people with 3 or more uncontrolled modifiable risk factors

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8479 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 16562 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 296911 0
Charities/Societies/Foundations
Name [1] 296911 0
Heart Foundation Future Leader Fellowship (co­funded) 100808. 2016­-2019.
Address [1] 296911 0
Level 12, 500 Collins Street Melbourne Vic
3000
Country [1] 296911 0
Australia
Funding source category [2] 296916 0
Government body
Name [2] 296916 0
NHMRC Career Development Fellowship (Level 2) APP1105447. Clinical approaches to preventing cardiovascular disease. 2016­-2019.
Address [2] 296916 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [2] 296916 0
Australia
Primary sponsor type
Individual
Name
Prof Clara Chow
Address
Westmead Applied Research Centre, REN Building
Westmead Hospital Cnr Darcy and Hawkesbury Roads, Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 295919 0
Individual
Name [1] 295919 0
Dr Harry Klimis
Address [1] 295919 0
Westmead Applied Research Centre, REN Building
Westmead Hospital Cnr Darcy and Hawkesbury Roads, Westmead NSW 2145
Country [1] 295919 0
Australia
Secondary sponsor category [2] 295921 0
Hospital
Name [2] 295921 0
Westmead Hospital
Address [2] 295921 0
Cnr Hawkesbury Road and Darcy Road
Westmead NSW 2145
Country [2] 295921 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298121 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 298121 0
Room 2050 Research & Education Network Building
Westmead Hospital
Cnr Hawkesbury and Darcy Roads,
Westmead, NSW 2145
Ethics committee country [1] 298121 0
Australia
Date submitted for ethics approval [1] 298121 0
12/04/2017
Approval date [1] 298121 0
19/06/2017
Ethics approval number [1] 298121 0
HREC/17/WMEAD/186

Summary
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).
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1854 1854 0 0
Attachments [4] 1860 1860 0 0

Contacts
Principal investigator
Name 76066 0
Prof Clara Chow
Address 76066 0
Westmead Applied Research Centre
Rm No 2041, Research & Education Network Building,
Cnr Hawkesbury and Darcy Roads, Westmead Hospital, Westmead NSW 2145

Country 76066 0
Australia
Phone 76066 0
+61 2 8890 3125
Fax 76066 0
+61 2 8890 8323
Email 76066 0
clara.chow@sydney.edu.au
Contact person for public queries
Name 76067 0
Prof Clara Chow
Address 76067 0
Westmead Applied Research Centre
Rm No 2041, Research & Education Network Building,
Cnr Hawkesbury and Darcy Roads, Westmead Hospital, Westmead NSW 2145

Country 76067 0
Australia
Phone 76067 0
+61 2 8890 3125
Fax 76067 0
+61 2 8890 8323
Email 76067 0
clara.chow@sydney.edu.au
Contact person for scientific queries
Name 76068 0
Dr Harry Klimis
Address 76068 0
Westmead Applied Research Centre
Rm No 2041, Research & Education Network Building,
Cnr Hawkesbury and Darcy Roads, Westmead Hospital, Westmead NSW 2145
Country 76068 0
Australia
Phone 76068 0
+61 2 8890 3125
Fax 76068 0
Email 76068 0
harry.klimis@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics limitations
What supporting documents are/will be available?
No other documents available
Summary results
No Results