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Trial registered on ANZCTR


Registration number
ACTRN12616001689460
Ethics application status
Approved
Date submitted
26/11/2016
Date registered
8/12/2016
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
SupportMe: Text messaging support for patients with chronic disease
Scientific title
A pragmatic, multicentre, single-blinded, parallel-group, randomised controlled trial to determine the effect of mobile phone text messaging intervention on blood pressure for patients with diabetes and cardiovascular diseases.-SupportMe
Secondary ID [1] 290455 0
None
Universal Trial Number (UTN)
Trial acronym
SupportMe
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Diseases 300819 0
Diabetes 301168 0
Heart Diseases 301169 0
Condition category
Condition code
Cardiovascular 300643 300643 0 0
Coronary heart disease
Metabolic and Endocrine 300644 300644 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The SupportMe intervention is a simple patient-centered text messaging intervention designed to provide semi-personalized support in clinical and behavioral management and link patients with providers and health services (hospital, community and GP). Messages will provide advice, motivation, information and support on their disease condition and tips to engage in healthy behaviours. The intervention will be individualised based on baseline information and clinical context, for example, non-smokers will not receive text messages on smoking. The 6 months intervention with 4 text messages per week will be sent to participant’s mobile phone. The message delivery software will monitor delivery of message i.e whether messages are delivered to participants. This will be followed by a 6 months maintenance phase where participants will receive 3-4 text messages per month.
Intervention code [1] 296304 0
Lifestyle
Intervention code [2] 296530 0
Treatment: Other
Intervention code [3] 296531 0
Behaviour
Comparator / control treatment
Control group will be patients with coronary heart disease or diabetes receiving standard-of-care. Patients in the control group will continue to receive usual care from their usual clinicians.
Control group
Active

Outcomes
Primary outcome [1] 300051 0
The primary outcome will be mean systolic blood pressure (SBP) at 6 months

SBP will be measured by study staff following the recommendations of the Australian National Heart Foundation (NHF). Patients will be rested in the seated position for 5 minutes, an appropriate cuff size will be selected, and 3 measurements of BP will be recorded, 5 minutes apart using an Omron or equivalent validated automated digital BP monitor. Principles of automated office BP measurements should be applied as practicable, whereby the patient is in a quiet room during BP recording. The primary outcome will be the mean of the 2nd and 3rd BP measurements.
Timepoint [1] 300051 0
6 months
Secondary outcome [1] 328922 0
Diastolic Blood pressure (DBP)

DBP will be measured by study staff using an Omron or equivalent validated automated digital BP monitor following the recommendations of the Australian National Heart Foundation (NHF).
Timepoint [1] 328922 0
6 Months
Secondary outcome [2] 328923 0
Low density lipoprotein (LDL) cholesterol

Serum LDL will be measured by serum assay.
Timepoint [2] 328923 0
6 Months
Secondary outcome [3] 328924 0
Body mass index (BMI)
Timepoint [3] 328924 0
6 Months
Secondary outcome [4] 329054 0
Smoking rate, quitting attempts

Self report
Timepoint [4] 329054 0
6 months
Secondary outcome [5] 329055 0
Physical activity- change in METS and sedentary time

By self-report using the Global Physical Activity Questionnaire (GPAQv2).
Timepoint [5] 329055 0
6 months
Secondary outcome [6] 329056 0
Fasting glucose

Fasting glucose will be measured by serum assay.
Timepoint [6] 329056 0
6 months
Secondary outcome [7] 329057 0
HbA1c in patients with diabetes

HbA1C will be measured by serum assay
Timepoint [7] 329057 0
6 months
Secondary outcome [8] 329058 0
Medical adherence –Self-report of use over last 30 days
Timepoint [8] 329058 0
6 months
Secondary outcome [9] 329059 0
Self-reported knowledge and behaviour change

A composite outcome measured using a questionnaire designed for this trial.
Timepoint [9] 329059 0
6 months
Secondary outcome [10] 329060 0
Quality of life – The 12-Item Short Form Health Survey (SF-12v2)
Timepoint [10] 329060 0
6 months
Secondary outcome [11] 329061 0
Depression- The Patient Health Questionnaire-9 (PHQ-9)
Timepoint [11] 329061 0
6 months
Secondary outcome [12] 329064 0
Composite outcome: Achieving Guideline Levels of Risk Factors: LDL-C <2 mmol/L (serum assay), Blood pressure <140/90 mm Hg (digital sphygmomanometry), Exercising regularly (Global Physical Activity Questionnaire), Nonsmoker (self-report), BMI <25 (physical measurements)
Composite outcome for diabetics: Achieving Guideline Levels of Risk Factors: LDL-C <2 mmol/L (serum assay), Blood pressure <140/90 mm Hg (digital sphygmomanometry), Exercising regularly (Global Physical Activity Questionnaire), Nonsmoker (self-report), BMI <25 (physical measurements) and HbA1c<7% (serum assay)
Timepoint [12] 329064 0
6 months
Secondary outcome [13] 329680 0
Economic evaluation: We will carry out both cost-effectiveness and cost-utility analysis of SupportMe from a health sector perspective.

By data linkage to hospital cost records and using data from PBS/MBS.

Timepoint [13] 329680 0
6 months
Secondary outcome [14] 329681 0
Process evaluation: We aim to examine the integration of the SupportMe program with existing services and initiatives including the barriers and enablers to implementation and translation using qualitative methodology (feedback questionnaires, focus group discussions and in-depth interviews) with patients and health providers.

By using study-specific questionnaires.
Timepoint [14] 329681 0
6 months
Secondary outcome [15] 329682 0
Additional outcome: Commencement of and completion of lifestyle/ behaviour modification program – linkage with Get healthy program,

A composite outcome will be measured using self-report on feedback questionnaire (Quitline, other programs).
Timepoint [15] 329682 0
6, 12 and 24 months
Secondary outcome [16] 329869 0
Additional outcome: Inpatient readmission.

Self report, hospital records and checked against linkage with NSW health hospital admission datasets, MBS and PBS.
Timepoint [16] 329869 0
6, 12 and 24 months
Secondary outcome [17] 329980 0
Additional outcome: Clinical events

Self reportSelf report, hospital records and checked against linkage with NSW health hospital admission datasets, MBS and PBS.
Timepoint [17] 329980 0
6, 12, 24 months
Secondary outcome [18] 329981 0
Additional outcome: Use of other health services (GP, specialists, hospitals, community services.

Self report, hospital records and checked against linkage with NSW health hospital admission datasets, MBS and PBS.
Timepoint [18] 329981 0
6, 12, 24 months

Eligibility
Key inclusion criteria
Patients will be 18 years or older, provide informed consent, be referred by a clinician in the WSLHD and meet all of the following:

a) At least one of the following clinical criteria:

1. Coronary heart disease (CHD) defined as 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 coronary angiography.

2. Type 2 Diabetes as diagnosed by a physician with an HbA1C greater than 7.o% and less than or equal to 11.0%

b) Own a mobile phone

c) Read text messages in English or one of the limited number of languages that we will provide in the program
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a. Unable to complete the study procedures and/or follow-up
b. Any condition that in the opinion of the responsible physician or investigator that renders the patient unsuitable for the study (e.g. severe disability or significant memory or behavioural disorder)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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
A sample size of 1000 patients will have 90% power to detect a difference of 3.5 mmHg in the primary outcome between intervention and control groups (Type 1 error 5%, 2 sided alpha, SD 17mmHg). We will recruit at least 500 patients with diabetes. We will stratify by diabetes. For each patient group (CHD or Diabetes) a sample size of 500 would have a 90% power to detect a 5mmHg difference in SBP. This translates to a 14% reduction in cardiovascular events. We expect 30% of patients with CHD to also have diabetes, so 650 patients to have diabetes in the total sample, this would give an 80% power to detect a difference of 0.26% in HbA1c (SD 1.2). This translates to a 5% reduction in diabetes complications.

All analyses of study outcomes will be conducted according to the principle of intention-to-treat. Baseline characteristics will be summarised by treatment groups. Continuous endpoints will be summarised by means/medians, with intervention effects tested by Wilcoxon test that assumes skewed data. If these data are not acceptably skewed, mixed models will describe the health related QoL, health utility score over time.
Our primary analyses will use analysis of covariance (ANCOVA) with baseline variables of analyses parameters uses as covariates where appropriate. This approach is recommended for analysing randomised trials of this nature. Heterogeneity of treatment on the primary endpoint will be assessed in pre-defined subgroups of the minimisation factors of ethnicity, baseline BP levels, and background BP lowering therapy, as well as age, time since index event, and presumed medical conditions. Analyses will be specified a priori in a full published statistical analysis plan.

Recruitment
Recruitment status
Active, not 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] 6896 0
Westmead Hospital - Westmead
Recruitment hospital [2] 6897 0
Blacktown Hospital - Blacktown
Recruitment hospital [3] 14646 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 14564 0
2145 - Westmead
Recruitment postcode(s) [2] 14565 0
2148 - Blacktown
Recruitment postcode(s) [3] 27670 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 294900 0
Government body
Name [1] 294900 0
NSW Health
Address [1] 294900 0
73 Miller Street
North Sydney NSW 2060
Australia
Country [1] 294900 0
Australia
Primary sponsor type
Government body
Name
Western Sydney Local Health District
Address
Institute Road, Westmead NSW 2145, Australia
Country
Australia
Secondary sponsor category [1] 293738 0
University
Name [1] 293738 0
The George Institute, University of Sydney
Address [1] 293738 0
The George Institute for Global Health, AUSTRALIA
Level 10, King George V Building, 83-117 Missenden Rd
Camperdown NSW 2050 Australia
Postal Address: PO Box M201
Missenden Rd NSW 2050 Australia
Country [1] 293738 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296277 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 296277 0
Research Office Level 2 REN Building Westmead Hospital, Hawkesbury & Darcy Roads, Westmead NSW 2145
Ethics committee country [1] 296277 0
Australia
Date submitted for ethics approval [1] 296277 0
17/08/2016
Approval date [1] 296277 0
02/12/2016
Ethics approval number [1] 296277 0

Summary
Brief summary
The SupportME is a pragmatic, multicentre, single-blinded, parallel-group, randomised controlled trial to determine the effect of mobile phone text messaging intervention on blood pressure for patients with diabetes and cardiovascular diseases. This study was funded by NSW Translational Research Grant. It aims to recruit 1000 patients with coronary heart diseases and/or type 2 diabetes. Patients will be randomised to text messaging intervention or standard-of-care. The primary outcome is the difference between groups in systolic blood pressure at 6 months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70134 0
Prof Clara K Chow
Address 70134 0
The George Institute for Global Health AUSTRALIA Level 10, King George V Building, 83-117 Missenden Rd Camperdown NSW 2050 Australia Postal Address: PO Box M201 Missenden Rd NSW 2050 Australia
Country 70134 0
Australia
Phone 70134 0
+61 2 8052 4525
Fax 70134 0
+61 2 8052 4502
Email 70134 0
cchow@georgeinstitute.org.au
Contact person for public queries
Name 70135 0
Dr Shariful Islam
Address 70135 0
The George Institute for Global Health AUSTRALIA Level 10, King George V Building, 83-117 Missenden Rd Camperdown NSW 2050 Australia Postal Address: PO Box M201 Missenden Rd NSW 2050 Australia
Country 70135 0
Australia
Phone 70135 0
+61 2 8052 4633
Fax 70135 0
+61 2 8052 4502
Email 70135 0
sislam@georgeinstitute.org.au
Contact person for scientific queries
Name 70136 0
Prof Clara K Chow
Address 70136 0
The George Institute for Global Health AUSTRALIA Level 10, King George V Building, 83-117 Missenden Rd Camperdown NSW 2050 Australia Postal Address: PO Box M201 Missenden Rd NSW 2050 Australia
Country 70136 0
Australia
Phone 70136 0
+61 2 8052 4525
Fax 70136 0
+61 2 8052 4502
Email 70136 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?
No
Results – basic reporting
Results – plain English summary