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Trial registered on ANZCTR


Registration number
ACTRN12614001232628
Ethics application status
Approved
Date submitted
12/11/2014
Date registered
25/11/2014
Date last updated
11/02/2021
Date data sharing statement initially provided
9/05/2019
Date results information initially provided
9/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Diabetes text message self management support
Scientific title
A randomized controlled trial to determine the efficacy of a text message based diabetes self management support program to improve glycaemic control, compared with usual care, in New Zealand adults with poorly controlled diabetes
Secondary ID [1] 285603 0
Health Research Council 14/724
Universal Trial Number (UTN)
U1111-1162-7072
Trial acronym
SMS4BG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 293448 0
Condition category
Condition code
Metabolic and Endocrine 293723 293723 0 0
Diabetes
Public Health 293724 293724 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a m-health diabetes self-management support program. Participants will receive an individually tailored package of text messages via their mobile phone to increase diabetes self-management. The dose and duration of messaging is tailored to the patients preferences ranging from 3 months to 9 months and from 2 messages per week to multiple messages per day.

The text messages are informational and motivational messages on a range of topics relevant to diabetes self-management. Topics include: General diabetes information, diabetes management tips, nutrition/diet, exercise, young adults with diabetes, stress and mood management, smoking, foot care as well as optional blood glucose monitoring reminders.

Participants who choose to respond to messages with their blood glucose test results will be able to view a graph of these results either by logging into a website or by opting to have their graph mailed to them.

The messages are tailored based on participant demographics (e.g. ethnicity and age), preferences (e.g. timing of messages, module choice, frequency of reminders) personal characteristics (e.g. motivations) and clinical characteristics (e.g. foot risk category, treatment). Tailoring information is obtained from those participants randomized to the intervention group during the baseline phone interview with a research assistant (approximately 20-30minutes).
Intervention code [1] 290555 0
Behaviour
Intervention code [2] 290657 0
Treatment: Other
Comparator / control treatment
The control group will receive usual care. Usual care, for the purposes of this study, includes the standard diabetes care provided in primary care settings including (e.g. GP and nurse visits, HbA1c tests) and where needed the care provided by secondary care services. In addition usual care includes where appropriate access to current diabetes resources and services.
Control group
Active

Outcomes
Primary outcome [1] 293534 0
Change in HbA1c as measured by blood test
Timepoint [1] 293534 0
Baseline and 9 months
Secondary outcome [1] 311276 0
Self-efficacy as measured by the Stanford Diabetes Self-Efficacy Scale
Timepoint [1] 311276 0
Baseline and 9 months
Secondary outcome [2] 311277 0
Diabetes self-care behaviors as measure by the Summary of Diabetes Self-Care Activities Measure
Timepoint [2] 311277 0
Baseline and 9 months
Secondary outcome [3] 311278 0
Diabetes distress as measured by the Diabetes Distress Screening Scale
Timepoint [3] 311278 0
Baseline and 9 months
Secondary outcome [4] 311279 0
Perceptions and beliefs about diabetes as measured by the Brief Illness Perceptions Questionnaire
Timepoint [4] 311279 0
Baseline and 9 months
Secondary outcome [5] 311280 0
Healthcare utilization via data collected from patient medical records
Timepoint [5] 311280 0
Baseline and 9 months
Secondary outcome [6] 311281 0
Intervention engagement (intervention group only) via system recorded data
Timepoint [6] 311281 0
Follow up (9 months)
Secondary outcome [7] 311282 0
Cost-effectiveness of the intervention using cost information, including cost of programme, and direct medical costs (including cost of treatment, primary care, secondary care) and Quality Adjusted Life Year (QALY).
Timepoint [7] 311282 0
9 months
Secondary outcome [8] 311283 0
Exit interview (intervention group only): satisfaction with the programme, including ease of use, issues arising, satisfaction with the text messages, salience and usefulness of the messages, and suggestions for improvement
Timepoint [8] 311283 0
9 months
Secondary outcome [9] 311284 0
HbA1c as measured by blood test
Timepoint [9] 311284 0
3 months and 6 months
Secondary outcome [10] 311614 0
Health related quality of life as measure by the EQ-5D
Timepoint [10] 311614 0
Baseline and 9 months
Secondary outcome [11] 313427 0
Perceived support for diabetes management via 4 items developed specifically for use in this study
Timepoint [11] 313427 0
Baseline and 9 months
Secondary outcome [12] 370258 0
Change in HbA1c as measured by blood test at 2 years
Timepoint [12] 370258 0
2 years

Eligibility
Key inclusion criteria
1. Aged 16 years or older
2. Have type 1 or type 2 diabetes
3. Have an HbA1c>65mmol/mol within the preceding 9 months
4. Have a mobile phone that can be used for this program
5. Provides informed consent
6. Able to read English
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Not available for the duration of the programme
2. Unable to use a mobile phone due to physical disabilities affecting eyesight or dexterity and do not have a carer who wishes to use the mobile tools on their behalf.

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)
Participants will be recruited through Primary Health Organizations (PHOs) and District Health Boards (DHBs). Healthcare professionals will identify potential participants according to the eligibility criteria. Contact details for those eligible and interested in participating will be forwarded to the research team, who will make contact to consent them and complete baseline measures over the phone. Alternatively participants will self-refer to the study and following confirmation of their eligibility they will complete consent and baseline measures over the phone.

Following baseline data collection, eligible participants will be randomised to either intervention or control group in a 1:1 ratio and stratified by diabetes type (1 or 2) and ethnicity (Maori & Pacific, or non-Maori & non-Pacific). The randomisation sequence will be generated by computer program and allocation concealed in consecutively numbered sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be generated by computer program and allocation concealed in consecutively numbered sealed envelopes.
Masking / blinding
Open (masking not 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
1/04/2015
Actual
16/06/2015
Date of last participant enrolment
Anticipated
Actual
7/11/2016
Date of last data collection
Anticipated
Actual
30/11/2018
Sample size
Target
1000
Accrual to date
Final
366
Recruitment outside Australia
Country [1] 6455 0
New Zealand
State/province [1] 6455 0

Funding & Sponsors
Funding source category [1] 290201 0
Government body
Name [1] 290201 0
Health Research Council
Country [1] 290201 0
New Zealand
Funding source category [2] 290884 0
Government body
Name [2] 290884 0
Ministry of Health
Country [2] 290884 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
National Institute for Health Innovation
School of Population Health
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 288913 0
Hospital
Name [1] 288913 0
Waitemata District Health Board (North Shore Hospital)
Address [1] 288913 0
North Shore Hospital
Private Bag 93 503
Takapuna
North Shore City 0740
Country [1] 288913 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291912 0
Health and Disability Ethics Committee
Ethics committee address [1] 291912 0
PO Box 5013
Wellington, 6145
New Zealand
Ethics committee country [1] 291912 0
New Zealand
Date submitted for ethics approval [1] 291912 0
Approval date [1] 291912 0
05/11/2014
Ethics approval number [1] 291912 0
14/STH/162

Summary
Brief summary
Diabetes is a national health priority due to its increasing prevalence and the costly consequences of poor control, particularly for Maori. Better diabetes control results in fewer long-term complications such as blindness, amputations, and heart disease. Mobile phone-based interventions have potential to support people to self-manage their diabetes and improve their communications with their healthcare team. This study will look at the benefits of a text message-based program (SMS4BG) developed by the National Institute for Health Innovation and Waitemata DHB for people with poorly-controlled diabetes. One thousand volunteers will be randomly assigned to receive either usual care alone or usual care plus the mHealth program to use for up to 9 months. The primary outcome will be change in HbA1c level from baseline to 9 months. This research will allow DHBs to make informed decisions on the use of technology-based support for self-management.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52534 0
Dr Robyn Whittaker
Address 52534 0
National Institute for Health Innovation
School of Population Health
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
Country 52534 0
New Zealand
Phone 52534 0
+64 9 3737599 ext. 84766
Fax 52534 0
Email 52534 0
r.whittaker@auckland.ac.nz
Contact person for public queries
Name 52535 0
Ms Rosie Dobson
Address 52535 0
National Institute for Health Innovation
School of Population Health
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
Country 52535 0
New Zealand
Phone 52535 0
+64 9 3737599 ext. 84766
Fax 52535 0
Email 52535 0
r.dobson@auckland.ac.nz
Contact person for scientific queries
Name 52536 0
Ms Rosie Dobson
Address 52536 0
National Institute for Health Innovation
School of Population Health
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
Country 52536 0
New Zealand
Phone 52536 0
+64 9 3737599 ext. 84766
Fax 52536 0
Email 52536 0
r.dobson@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The research team will consider reasonable requests for sharing of deidentified patient level data. Consent for data sharing was not obtained but the presented data are anonymised and risk of identification is low.
When will data be available (start and end dates)?
current to 31/10/2024
Available to whom?
Case by case basis at the discretion of the Principal Investigator.
Available for what types of analyses?
Only analyses related to the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by Principal Investigator and completion of a data access agreement.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1862Study protocol    Dobson, R. Whittaker, R. Jiang, Y. Shepherd, M. Ma... [More Details] 367369-(Uploaded-12-04-2019-10-37-03)-Study-related document.pdf
10610Statistical analysis plan  r.dobson@auckland.ac.nz Available from Principal Investigator on email req... [More Details]
10611Informed consent form  r.dobson@auckland.ac.nz Available from Principal Investigator via email re... [More Details]
10612Ethical approval  r.dobson@auckland.ac.nz Approval letter available from Principal Investiga... [More Details]



Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffectiveness of text message based, diabetes self management support programme (SMS4BG): Two arm, parallel randomised controlled trial.2018https://dx.doi.org/10.1136/bmj.k1959
EmbaseLong-term follow-up of a randomized controlled trial of a text-message diabetes self-management support programme, SMS4BG.2020https://dx.doi.org/10.1111/dme.14182
N.B. These documents automatically identified may not have been verified by the study sponsor.