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Trial registered on ANZCTR


Registration number
ACTRN12613000793718
Ethics application status
Approved
Date submitted
18/06/2013
Date registered
16/07/2013
Date last updated
26/08/2019
Date data sharing statement initially provided
26/08/2019
Date results information initially provided
26/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
TEXT messages to improve MEDication adherence & Secondary prevention - TEXTMEDS
Scientific title
TEXT messages to improve MEDication adherence & Secondary prevention in patients with acute coronary syndrome - TEXTMEDS
Secondary ID [1] 282691 0
Nil
Universal Trial Number (UTN)
U1111-1144-6043
Trial acronym
TEXTMEDS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
coronary heart disease 289404 0
Condition category
Condition code
Cardiovascular 289727 289727 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive secondary prevention support program delivered via mobile phone text message and an opportunity to communicate with a health counsellor over a 12 month period. The messages will provide education, support, motivation and reminders with respect to medications and lifestyle. As the focus is medication adherence at least 1 message per week will be about medications. Messages will be delivered on average 4 times per week. Participants can respond to their daily text message to ask advice from their health counsellor. All responses from participants to text messages will be reviewed and responded to by the health counsellor. Once a month participants will be asked if they would like more information or support, if they reply ‘yes’ – they will be contacted by a health counsellor.
Intervention code [1] 287351 0
Behaviour
Comparator / control treatment
Usual care - The control group will receive standard care for their cardiovascular health including pharmacotherapy and lifestyle counselling as determined by their usual doctors.
Control group
Active

Outcomes
Primary outcome [1] 289821 0
The proportion of patients regularly taking appropriate secondary prevention medications
Timepoint [1] 289821 0
1 year
Secondary outcome [1] 303314 0
Objective measures of cardiovascular risk factors - mean total cholesterol, mean LDL cholesterol, mean systolic blood pressure at 12 months. Total cholesterol and LDL cholesterol will be measures on venous blood samples obtained from participants at the 12 month follow-up. Blood pressure will be measured using a digital blood pressure monitor.
Timepoint [1] 303314 0
1 year
Secondary outcome [2] 303315 0
Proportion regularly using each medication class. This will be self-reported using a standardised questionnaire.
Timepoint [2] 303315 0
1 year
Secondary outcome [3] 303316 0
Behavioural risk factors - Smoking, physical activity and fruit and vegetable intake. Smoking will be assessed using a standardised questionaire. Physical activity will be measured using the Active Australia Questionnaire and diet measured using a sub-sample of questions on fruit and vegetable intake from the WHO steps instrument.
Timepoint [3] 303316 0
1 year
Secondary outcome [4] 303317 0
Major vascular event (CV death, non-fatal AMI, stroke or hospital admission with unstable angina or congestive heart failure), coronary revascularisation (coronary artery bypass graft surgery or percutaneous coronary intervention), Death, hospital readmission. This will be measured at 12 months using self-report and additional supporting documentation will be collected by study staff for central adjudication.
Timepoint [4] 303317 0
1 year
Secondary outcome [5] 303318 0
psychosocial factors including anxiety and depressive symptoms will be assessed using the GAD7 and PHQ-9 questionnaires.
Timepoint [5] 303318 0
1 year

Eligibility
Key inclusion criteria
Acute coronary syndrome, a planned return to the community, ability to provide informed consent, own an operational mobile telephone and sufficient skill in English language to read and send text messages.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients that do not have inclusion criteria

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)
Patients with acute coronary syndrome will be screened in hospital for inclusion criteria, informed consent obtained , baseline data required to personalise the intervention program will be collected and patients will be enrolled into the study. Centre study staff will enter data into an electronic case report form. Allocation to intervention or control will be done centrally and concealed from study personnel until the completion of the trial. Study personnel taking follow-up assessments will also be blinded to parallel group assignments.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur using a centralised, computerised randomisation program. The random allocation sequence will be in a uniform 1:1.
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
We will follow the intention to treat principle and analyse patients in the treatment group to which they are allocated. Characteristics will be compared between the two groups using independent ttests or chi-square tests as is appropriate. We will analyse the primary outcome at the end of followup
with the chi-square test. The primary analysis will be unadjusted. We will compare the mean level or proportion using chi-square or t-test as relevant for each of the secondary outcome measures as well as calculate the relative risks, 95% confidence intervals and two-sided p-values.
We will also calculate the number needed to treat (NNT) and its 95% CI for the primary outcome. We will investigate the possible effects of baseline effect modifiers or confounders using logistic regression analysis. We will analyse effects across subgroups using logistic regression models with
and without interaction terms between treatment allocation and sub-group defining variables using the likelihood-ratio test. The criterion for statistical significance will be set at 0.05.
We considered a 10% improvement in the proportion taking appropriate secondary prevention to be a clinically meaningful increase as such results have been associated with a 10% decrease in short-term mortality. To test for a 10% improvement in the primary outcome (RR of 1.10) in the treatment compared to the control arm (assuming about 70% of patients are taking appropriate secondary prevention in control arm, based on the CONCORDANCE registry, and this would rise to 77% in the intervention arm) with 80% power (type I error = 5%, two-sided test) we would require a total sample size of 1256, rising to about 1385 accounting for about 10% loss to follow up. This sample size of 1256 would enable us to also detect with 80% power a minimum detectable difference in secondary outcomes of i) 1.5 mmol in total cholesterol assuming a standard deviation (SD) of 0.96mmol/L, ii) 2.7 mmHg in systolic blood pressure, assuming a SD of 17mmHg and a minimum detectable relative risk of 0.69 in CV events assuming a major CV event rate of 19% based on data from CONCORDANCE.

Recruitment
Recruitment status
Completed
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,NT,QLD,SA,WA
Recruitment hospital [1] 14625 0
Westmead Hospital - Westmead
Recruitment hospital [2] 14626 0
Concord Repatriation Hospital - Concord
Recruitment hospital [3] 14627 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [4] 14628 0
Liverpool Hospital - Liverpool
Recruitment hospital [5] 14629 0
Nepean Hospital - Kingswood
Recruitment hospital [6] 14630 0
Wollongong Hospital - Wollongong
Recruitment hospital [7] 14631 0
Shoalhaven Hospital - Nowra
Recruitment hospital [8] 14632 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment hospital [9] 14633 0
Coffs Harbour Base Hospital - Coffs Harbour
Recruitment hospital [10] 14634 0
Nambour General Hospital - Nambour
Recruitment hospital [11] 14635 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [12] 14636 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [13] 14637 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [14] 14638 0
Royal Perth Hospital - Perth
Recruitment hospital [15] 14639 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [16] 14640 0
Alice Springs Hospital - Alice Springs
Recruitment hospital [17] 14641 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [18] 14642 0
The Townsville Hospital - Douglas
Recruitment hospital [19] 14643 0
The Prince Charles Hospital - Chermside
Recruitment hospital [20] 14644 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [21] 14645 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 27649 0
0870 - Alice Springs
Recruitment postcode(s) [2] 27650 0
6150 - Murdoch
Recruitment postcode(s) [3] 27651 0
4814 - Douglas
Recruitment postcode(s) [4] 27652 0
4032 - Chermside
Recruitment postcode(s) [5] 27653 0
2065 - St Leonards
Recruitment postcode(s) [6] 27654 0
2050 - Camperdown
Recruitment postcode(s) [7] 27655 0
2145 - Westmead
Recruitment postcode(s) [8] 27656 0
2137 - Concord
Recruitment postcode(s) [9] 27657 0
2450 - Coffs Harbour
Recruitment postcode(s) [10] 27658 0
2200 - Bankstown
Recruitment postcode(s) [11] 27659 0
2170 - Liverpool
Recruitment postcode(s) [12] 27660 0
2340 - Kingswood
Recruitment postcode(s) [13] 27661 0
2500 - Wollongong
Recruitment postcode(s) [14] 27662 0
2541 - Nowra
Recruitment postcode(s) [15] 27663 0
2305 - New Lambton
Recruitment postcode(s) [16] 27664 0
4560 - Nambour
Recruitment postcode(s) [17] 27665 0
4029 - Royal Brisbane Hospital
Recruitment postcode(s) [18] 27666 0
5042 - Bedford Park
Recruitment postcode(s) [19] 27667 0
6009 - Nedlands
Recruitment postcode(s) [20] 27668 0
6000 - Perth
Recruitment postcode(s) [21] 27669 0
0810 - Tiwi

Funding & Sponsors
Funding source category [1] 287463 0
Government body
Name [1] 287463 0
National Health and Medical Research Council (NHMRC)
Address [1] 287463 0
National Health and Medical Research Council
GPO Box 1421
Canberra City ACT 2601
Country [1] 287463 0
Australia
Primary sponsor type
University
Name
The George Institute for Global Health, University of Sydney
Address
PO Box M201
Missenden Rd
NSW 2050 Australia
Country
Australia
Secondary sponsor category [1] 286207 0
Hospital
Name [1] 286207 0
Westmead Hospital
Address [1] 286207 0
Darcy road
Westmead
NSW 2145
Country [1] 286207 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289442 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 289442 0
Research Office, Room 1072, Level 1, Education Block
Westmead Hospital, Hawkesbury & Darcy Roads, Westmead NSW 2145
Ethics committee country [1] 289442 0
Australia
Date submitted for ethics approval [1] 289442 0
Approval date [1] 289442 0
13/03/2013
Ethics approval number [1] 289442 0
HREC2012/12/4.1 (3648) AU RED HREC/13/WMEAD/15

Summary
Brief summary
TEXTMEDS is a randomised controlled trial of 1400 patients with acute coronary syndrome (ACS) that will evaluate an innovative secondary prevention support program delivered via mobile phone text message. TEXTMEDS aims to improve medication adherence and control of cardiovascular risk factors in patients with ACS.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40850 0
A/Prof Clara Chow
Address 40850 0
The George Institute for Global Health, University of Sydney
PO Box M201
Missenden Road
NSW 2050
Country 40850 0
Australia
Phone 40850 0
61299934500
Fax 40850 0
61299934502
Email 40850 0
cchow@georgeinstitute.org.au
Contact person for public queries
Name 40851 0
Ms Sandra Bahamad
Address 40851 0
The George Institute or Global Health
PO Box M201
Missenden Road
NSW 2050
Country 40851 0
Australia
Phone 40851 0
61299934565
Fax 40851 0
Email 40851 0
sbahamad@georgeinstitute.org.au
Contact person for scientific queries
Name 40852 0
A/Prof Clara Chow
Address 40852 0
The George Institute for Global Health
PO Box M201
Missenden Road
NSW 2050
Country 40852 0
Australia
Phone 40852 0
+61299934500
Fax 40852 0
Email 40852 0
cchow@georgeinstitute.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary