Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000277549
Ethics application status
Approved
Date submitted
6/06/2013
Date registered
24/03/2015
Date last updated
24/03/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Non-randomised pilot study of a text message self-management support programme for people with diabetes
Scientific title
Non-randomised pilot study on the acceptability and efficacy of a text message self-management support programme for people with diabetes
Secondary ID [1] 282631 0
nil
Universal Trial Number (UTN)
Trial acronym
SMS4BG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetes 289325 0
Condition category
Condition code
Metabolic and Endocrine 289667 289667 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An automated tailored text messaging programme with self-selected modules. A core programme of motivational support messages (2/week) in Maori or non-Maori versions; add-on modules include blood glucose monitoring reminders at a selected frequency (from 1/week to 4/day); insulin information (1/week); adolescent messages (1/week); self-selected goals around healthy eating, physical activity or stress/mood management (start at 4/week and reduce in frequency). The three month programme aims to support and enhance self-management of diabetes and other wellness goals between clinic visits
Intervention code [1] 287298 0
Behaviour
Comparator / control treatment
NA - This is a single group study control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289748 0
HbA1c laboratory tests in the past 12 months at baseline and HbA1c laboratory tests after the programme
Timepoint [1] 289748 0
At baseline and at the end of the text message programme (3 months)
Secondary outcome [1] 303181 0
Participant satisfaction - via open ended questions developed specifically for this study
Timepoint [1] 303181 0
at 3 months after the start of the programme
Secondary outcome [2] 303337 0
Sense of control - via open ended question designed for this study
Timepoint [2] 303337 0
3 months after the start of the programme
Secondary outcome [3] 303338 0
Blood glucose monitoring - self-reported via open ended question
Timepoint [3] 303338 0
over the course of the 3 month programme
Secondary outcome [4] 303339 0
clinician satisfaction - a satisfaction questionnaire will be developed by researchers
Timepoint [4] 303339 0
at 3 months after the start of the programme

Eligibility
Key inclusion criteria
type 1 or type 2 diabetes
16-65 years
on insulin
HbA1c greater than 70
have a mobile phone
Minimum age
16 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not available for the duration of the programme

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will receive a participant information sheet explaining the study purpose and procedures from the 
Doctor or nurse in charge of their diabetes care. They will be given the opportunity to ask questions and time to 
discuss participation with their family/whanau. They will be given the opportunity to contact the research team for 
further information. Consent to receive the text messages will be given via text 'I consent'. A researcher will contact 
the participant to discuss participation in the evaluation component, questions will be answered and the participant 
will be given time to consider. Verbal consent will be obtained and a copy of the consent form posted to the 
participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
no randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to describe the change in HbA1c over 3 months. Qualitative feedback will be reported using a general thematic analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/07/2013
Actual
22/07/2013
Date of last participant enrolment
Anticipated
31/08/2013
Actual
26/08/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 5129 0
New Zealand
State/province [1] 5129 0
Auckland

Funding & Sponsors
Funding source category [1] 287410 0
Hospital
Name [1] 287410 0
Waitemata District Health Board
Country [1] 287410 0
New Zealand
Primary sponsor type
Hospital
Name
Waitemata District Health Board
Address
15 Shea Terrace
Takapuna
Auckland 0622
Country
New Zealand
Secondary sponsor category [1] 286155 0
University
Name [1] 286155 0
National Institute for Health Innovation
Address [1] 286155 0
School of Population Health Tamaki Campus University of Auckland Private Bag 92019 Auckland 1142
Country [1] 286155 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289385 0
University of Auckland Human Subjects Ethics Committee
Ethics committee address [1] 289385 0
University of Auckland
Private Bag 92019
Auckland 1142
Ethics committee country [1] 289385 0
New Zealand
Date submitted for ethics approval [1] 289385 0
Approval date [1] 289385 0
07/05/2013
Ethics approval number [1] 289385 0
13/NTA/55

Summary
Brief summary
This pilot study will assess the acceptability and efficacy of a text message theory-based self-management support programme that aims to enhance control of diabetes.
Trial website
Trial related presentations / publications
Dobson, R., Carter, K., Cutfield, R., Hulme, A., Hulme, R., McNamara, C., Maddison, R., Murphy, R., Shepherd, M., Strydom, J., & Whittaker, R. Diabetes Text-Message Self-Management Support Program (SMS4BG): A Pilot Study. JMIR mHeatlh and uHealth (in press)
Public notes

Contacts
Principal investigator
Name 40582 0
Dr Robyn Whittaker
Address 40582 0
National Institute for Health Innovation
University of Auckland
Private Bag 92019
Auckland 1142
Country 40582 0
New Zealand
Phone 40582 0
+6499234766
Fax 40582 0
Email 40582 0
[email protected]
Contact person for public queries
Name 40583 0
Dr Robyn Whittaker
Address 40583 0
National Institute for Health Innovation
University of Auckland
Private Bag 92019
Auckland 1142
Country 40583 0
New Zealand
Phone 40583 0
+6499234766
Fax 40583 0
Email 40583 0
[email protected]
Contact person for scientific queries
Name 40584 0
Dr Robyn Whittaker
Address 40584 0
National Institute for Health Innovation
University of Auckland
Private Bag 92019
Auckland 1142
Country 40584 0
New Zealand
Phone 40584 0
+6499234766
Fax 40584 0
Email 40584 0
[email protected]

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
No additional documents have been identified.