Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000479202
Ethics application status
Approved
Date submitted
5/03/2018
Date registered
3/04/2018
Date last updated
21/02/2020
Date data sharing statement initially provided
6/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving Engagement in Patients with Young Adult Onset Type 2 Diabetes (Text2U)
Scientific title
Improving Engagement in Patients with Young Adult Onset Type 2 Diabetes through implementation of an SMS intervention (Text2U)
Secondary ID [1] 292792 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Young Adult Onset Type 2 Diabetes 304601 0
Condition category
Condition code
Metabolic and Endocrine 303926 303926 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised using a computerised system in a ratio of 1:1 into one of two intervention strategies described below (Intervention Strategy A and Intervention Strategy B). Participants will progress through the twelve month study period and undergo quarterly study assessments.

Treatment Strategies

Intervention Strategy B – SMS-based

• Current Standard of Care System PLUS
• An initial eight-week, twice weekly SMS relating to diabetes management (including general diabetes information and reminders about diabetes-specific self-care measures)
• Monthly “check-in” text messages from the study team after the initial eight-week SMS program. Similarly to the initial eight-week, twice weekly SMS component of the program these "check-in" text messages will include general diabetes information and reminders about diabetes-specific self-care measures.
• An option for patients to send a question via SMS to a study co-ordinator between clinic visits and receive a reply within 72 h
• A personalised appointment reminder SMS before the next appointment
Intervention code [1] 299032 0
Treatment: Other
Comparator / control treatment
Intervention Strategy A – Current standard of care

• Quarterly in-person clinic appointments at the Diabetes Centre (with Endocrinologist and Diabetes Educator)
• Automated SMS reminder at a pre-defined time prior to next appointment (SMS generated by an automated system for RPAH Outpatients)
• Dietary education provided by the Diabetes Centre Dietitian
• Provision of a personal blood glucose monitor for self-monitoring at home
• Quarterly glycaemic control assessment via HbA1c (and other routine pathology tests)
• An annual Diabetes Complications Assessment (performed during one of the quarterly in-person clinic appointments)
Control group
Active

Outcomes
Primary outcome [1] 303262 0
Determine the efficacy of an enhanced SMS-based message strategy at improving clinic attendance. The enhanced SMS strategy will be tested against the current standard of care. The proportion of clinic appointments attended by a participant will be assessed by review of attendance records.
Timepoint [1] 303262 0
12 months
Secondary outcome [1] 338663 0
Availability of pathology results at the time of follow-up clinic appointments. This will be assessed by review of medical records at the time of each follow up appointment.
Timepoint [1] 338663 0
At each quarterly follow up appointment for 12 months after intervention commencement.
Secondary outcome [2] 338664 0
Adherence to blood glucose monitoring (via assessment of blood glucose monitor uploads)
Timepoint [2] 338664 0
At each quarterly follow up appointment for 12 months after intervention commencement.
Secondary outcome [3] 338665 0
Problem Areas in Diabetes (PAID-5) Questionnaire Score
Timepoint [3] 338665 0
At baseline, after six months on study and at study completion (12 months)
Secondary outcome [4] 338666 0
Diabetes Empowerment Scale-Short Form Score
Timepoint [4] 338666 0
At baseline, after six months on study and at study completion (12 months)
Secondary outcome [5] 344952 0
Health Literacy Questionnaire (Orphelia) Score
Timepoint [5] 344952 0
At baseline, after six months on study and at study completion (12 months)
Secondary outcome [6] 344953 0
Diabetes Stigma Assessment Scale-2 Score
Timepoint [6] 344953 0
At baseline, after 6 months on study and at study completion (12 months)
Secondary outcome [7] 344954 0
HbA1c
Timepoint [7] 344954 0
At each quarterly visit for 12 months after intervention commencement
Secondary outcome [8] 344955 0
Blood pressure
Timepoint [8] 344955 0
At each quarterly visit for 12 months after intervention commencement
Secondary outcome [9] 344956 0
Weight
Timepoint [9] 344956 0
At each quarterly visit for 12 months after intervention commencement
Secondary outcome [10] 344957 0
Cholesterol level
Timepoint [10] 344957 0
At baseline and at study completion (12 months)
Secondary outcome [11] 344958 0
Spot urine albumin to creatinine ratio
Timepoint [11] 344958 0
At baseline and at study completion (12 months)

Eligibility
Key inclusion criteria
1. Type 2 diabetes (HbA1c >6.5% or positive oral glucose tolerance test)
2. 18-40 years of age at time of study entry
3. Access to a mobile telephone

Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Type 1 diabetes
2. Age >40 years

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed via the use of a central computer program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer software.
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
An audit of attendance at the RPAH Diabetes Centre has demonstrated that the median time to clinic drop-out in the YT2DM cohort enrolled in our current standard of care system is approximately 4 months. External studies which have compared the effect of a text messaging intervention and a control intervention on attendance at follow up appointments have found Odds Ratios in the range of 1.7-4.3 in favour of the text messaging intervention (Lin H & Wu X. Intervention Strategies for Improving Patient Adherence to Follow-Up in the Era of Mobile Information Technology: A Systematic Review and Meta-Analysis. PLOS ONE. 2014; 9(8): e104266). Using this information, we estimate that application of an enhanced text messaging system will improve the median time to clinic drop-out in our YT2DM cohort from 4 months to 12 months. If the true median drop-out times in the current and the enhanced text messaging systems are 4 and 12 months respectively, we will need to study 20 subjects using the current system and 20 subjects using the enhanced text messaging system to be able to reject the null hypothesis (that there is no difference between the current and enhanced systems) with 80% power (a=0.05).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/03/2018
Date of last participant enrolment
Anticipated
1/06/2018
Actual
21/08/2018
Date of last data collection
Anticipated
30/09/2019
Actual
26/09/2019
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8970 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 17467 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 297424 0
Hospital
Name [1] 297424 0
Royal Prince Alfred Hospital, Department of Endocrinology
Country [1] 297424 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Level 6 West Wing, Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 296417 0
None
Name [1] 296417 0
Address [1] 296417 0
Country [1] 296417 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298530 0
SLHD Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 298530 0
Ethics committee country [1] 298530 0
Australia
Date submitted for ethics approval [1] 298530 0
24/08/2017
Approval date [1] 298530 0
01/09/2017
Ethics approval number [1] 298530 0
X17-0270 & HREC /17/RPAH/401

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77374 0
Dr Timothy Middleton
Address 77374 0
Diabetes Centre, Level 6 West Wing
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 77374 0
Australia
Phone 77374 0
+61 2 9515 5888
Fax 77374 0
+61 2 9515 5820
Email 77374 0
[email protected]
Contact person for public queries
Name 77375 0
Timothy Middleton
Address 77375 0
Diabetes Centre, Level 6 West Wing
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 77375 0
Australia
Phone 77375 0
+61 2 9515 5888
Fax 77375 0
+61 2 9515 5820
Email 77375 0
[email protected]
Contact person for scientific queries
Name 77376 0
Timothy Middleton
Address 77376 0
Diabetes Centre, Level 6 West Wing
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 77376 0
Australia
Phone 77376 0
+61 2 9515 5888
Fax 77376 0
+61 2 9515 5820
Email 77376 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethical approval was not sought for sharing of individual participant data


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.