Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000161921
Ethics application status
Approved
Date submitted
3/02/2011
Date registered
10/02/2011
Date last updated
18/05/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Tobacco, EXercise and dieT MEssages (TEXT ME): The effect of semi-personalised lifestyle reminder text message intervention on cardiovascular disease risk.
Scientific title
Tobacco, EXercise and dieT MEssages (TEXT ME): The effect of a semi-personalised lifestyle reminder text message intervention on cardiovascular risk factors in patients with cardiovascular disease and those who are at high risk of cardiovascular disease.
Secondary ID [1] 253373 0
NONE
Universal Trial Number (UTN)
U1111-1118-9517
Trial acronym
TEXT ME
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with cardiovascular disease or who are at high risk of cardiovascular events 260915 0
Condition category
Condition code
Cardiovascular 259053 259053 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will receive regular semi-personalized lifestyle reminders sent via mobile phone text messages for 6 months. Each participants will receive 4 text messages per week for 6 months. These will be sent at random times of the day (9.00am, 12noon, 3.00pm, 5.00pm) and on random days of the week (Monday through Friday). Non-smokers will receive two general messages, one nutritional message and one physical activity message per week. Smokers will receive one general message, one nutritional message, one physical activity message and one smoking cessation message per week. Messages will be practical in nature, less than 160 characters in length and will be generic for varying age and genders. Prior to study commencement, a bank of 100 messages will be developed based on scientific literature and multidisciplinary expert review and finalised via a qualitative review process.
Intervention code [1] 257813 0
Prevention
Intervention code [2] 257814 0
Treatment: Other
Intervention code [3] 257815 0
Lifestyle
Comparator / control treatment
Treatment Group: Participants in the treatment group will receive repeated semi-personalized lifestyle reminders sent via mobile phone text messages for 6 months

Control Group: Participants in the control group will participate in "usual care". Usual care will include ongoing management by the patient's treating doctor/s including potential pharmacotherapy and lifestyle counseling as determined by their usual doctors.
Control group
Active

Outcomes
Primary outcome [1] 259898 0
Low density lipoprotein cholesterol measured by fasting blood sample.
Timepoint [1] 259898 0
Baseline and 6 months.
Primary outcome [2] 259909 0
Systolic blood pressure measured by sitting digital recording, mean of the last 2 readings of 3.
Timepoint [2] 259909 0
Baseline and 6 months.
Primary outcome [3] 259910 0
Body mass index and waist circumference measured via digital scales and tape measure accoding to national standards.
Timepoint [3] 259910 0
Baseline and 6 months.
Secondary outcome [1] 268802 0
Level of physical activity measured via Active Australia Questionnaire and confirmed via a subsample participating in accelerometry.
Timepoint [1] 268802 0
Baseline and 6 months.
Secondary outcome [2] 268803 0
Tobacco smoking measured by CO meter and self report.
Timepoint [2] 268803 0
Baseline and 6 months.
Secondary outcome [3] 268804 0
Fruit and vegetable intake measured by prior 7 days self-report.
Timepoint [3] 268804 0
Baseline and 6 months.
Secondary outcome [4] 273084 0
Cardioprotective medication use measured by self-report and validated through prescription data onbtained via the Pharmaceutical Benefits Scheme (PBS).
Timepoint [4] 273084 0
Baseline and 6 months.
Secondary outcome [5] 273085 0
Psychosocial statis measured via SF12 and PHQ9 questionnaires.
Timepoint [5] 273085 0
Baseline and 6 months.

Eligibility
Key inclusion criteria
Any patient over the age of 18 who has come to hospital for investigation of coronary artery disease, or who has been admitted to hospital for cardiovascular disease
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under 18 years of age, unable to read english (unable to read text messages) or patients without access to mobile phone.

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 research assistant during a very brief face to face meeting during the inpatient stay. The researcher will establish whether the patient is interested in volunteering and if they consent they will be randomised.
The patients will be allocated by central randomisation by computer and the on site staff will not have access to the details of randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by computer software (computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2011
Actual
2/09/2011
Date of last participant enrolment
Anticipated
Actual
19/11/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258294 0
Charities/Societies/Foundations
Name [1] 258294 0
National Heart Foundation
Country [1] 258294 0
Australia
Primary sponsor type
Individual
Name
Dr Clara Chow
Address
PO Box M201
Missenden Rd
Camperdown
NSW
2050
Country
Australia
Secondary sponsor category [1] 257457 0
Individual
Name [1] 257457 0
Dr Julie Redfern
Address [1] 257457 0
PO Box M201
Missenden Road
Camperdown, NSW
2050
Country [1] 257457 0
Australia
Other collaborator category [1] 251765 0
Individual
Name [1] 251765 0
Dr Aravinda Thiagalingam
Address [1] 251765 0
Westmead Hospital
Hawksbury Street
Westmead, NSW
2145
Country [1] 251765 0
Australia
Other collaborator category [2] 251766 0
Individual
Name [2] 251766 0
Graham Hillis
Address [2] 251766 0
PO Box M201
Missenden Road
Camperdown, NSW
2050
Country [2] 251766 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260409 0
SWAHS Human Research Ethics Committee (Westmead Campus)
Ethics committee address [1] 260409 0
SWAHS Human Research Ethics Committee
Research Office, Westmead Hospital
Hawkesbury Road, Westmead NSW 2145
Ethics committee country [1] 260409 0
Australia
Date submitted for ethics approval [1] 260409 0
19/01/2011
Approval date [1] 260409 0
04/04/2011
Ethics approval number [1] 260409 0

Summary
Brief summary
To establish the feasibility, patient acceptability, effect on risk factors and thereby overall potential of repeated semi-personalized lifestyle reminders sent via mobile phone text messages in a population at high risk of cardiovascular events.
The main hypothesis that will be tested is that a program of brief and repeated lifestyle messages will improve cardiovascular risk factor levels compared to usual care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32068 0
A/Prof Clara Chow
Address 32068 0
The George Institute, PO Box M201 Missenden Road Camperdown, NSW 2050
Country 32068 0
Australia
Phone 32068 0
+61299934525
Fax 32068 0
Email 32068 0
cchow@georgeinstitute.org.au
Contact person for public queries
Name 15315 0
A/Prof Clara Chow
Address 15315 0
PO Box M201
Missenden Road
Camperdown, NSW
2050
Country 15315 0
Australia
Phone 15315 0
+61 2 99934525
Fax 15315 0
+61 2 99034502
Email 15315 0
cchow@georgeinstitute.org.au
Contact person for scientific queries
Name 6243 0
A/Prof Clara Chow
Address 6243 0
PO Box M201
Missenden Road
Camperdown, NSW
2050
Country 6243 0
Australia
Phone 6243 0
+61 2 99934525
Fax 6243 0
+61 2 99034502
Email 6243 0
cchow@georgeinstitute.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of text messaging on depression in patients with coronary heart disease: A substudy analysis from the TEXT ME randomised controlled trial.2019https://dx.doi.org/10.1136/bmjopen-2018-022637
EmbaseEffect of lifestyle-focused text messaging on risk factor modification in patients with coronary heart disease: A randomized clinical trial.2015https://dx.doi.org/10.1001/jama.2015.10945
EmbaseLifestyle-focused text messages reduced LDL-C levels, systolic BP, and BMI in coronary heart disease.2016https://dx.doi.org/10.7326/ACPJC-2016-164-2-007
EmbaseFactors influencing engagement, perceived usefulness and behavioral mechanisms associated with a text message support program.2016https://dx.doi.org/10.1371/journal.pone.0163929
EmbaseThe effects of a lifestyle-focused text-messaging intervention on adherence to dietary guideline recommendations in patients with coronary heart disease: An analysis of the TEXT ME study.2018https://dx.doi.org/10.1186/s12966-018-0677-1
N.B. These documents automatically identified may not have been verified by the study sponsor.