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Trial registered on ANZCTR


Registration number
ACTRN12623000978662p
Ethics application status
Submitted, not yet approved
Date submitted
2/06/2023
Date registered
8/09/2023
Date last updated
8/09/2023
Date data sharing statement initially provided
8/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of an interactive, SMS-based diabetes distress support program for Type 1 Diabetes patients
Scientific title
Feasibility of an interactive, SMS-based diabetes distress support program for Type 1 Diabetes patients
Secondary ID [1] 309820 0
None
Universal Trial Number (UTN)
Trial acronym
T1DDS
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Diabetes
 330236 0
Distress 330237 0
Condition category
Condition code
Metabolic and Endocrine 327107 327107 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A pilot, randomised controlled trial designed to test the feasibility of an interactive, SMS-based diabetes distress support program over a 6-month period against standard of care at the Royal Prince Alfred Hospital) RPAH Diabetes Centre. The pilot RCT will assess current clinic standard of care (Strategy A) against clinic standard of care plus SMS support (Strategy B). All participants will complete the T1-DDS score, PAID-5 score, DES-SF score, DSAS-1 score on two occasions, at baseline and at six-months.

All participants will complete the T1-DDS score, PAID-5 score, DES-SF score, DSAS-1 score on two occasions, at baseline and at six-months.

Strategy A – Current standard of care (Quarterly - once every 3 months)
• Quarterly in-person clinic appointments at the Diabetes Centre or via telehealth (with Endocrinologist and Diabetes Educator) for review of glycaemia, routine pathology test results, complication screening and treatment adjustment
• Dietary review/education with the Diabetes Centre Dietitian (as required)
• Provision of a personal blood glucose monitor (or an alternative monitoring modality – Continuous Glucose Monitoring (CGM) or flash glucose monitoring) for self-monitoring of glycaemia at home

Strategy B – Standard of care PLUS SMS support (SMS4T1D)
• Current standard of care PLUS
• A semi-personalised (male/female, name), twice weekly SMS relating to diabetes management (including general diabetes information [healthy eating, hypo support] and reminders about diabetes-specific self-care measures)
• An option to engage with staff of the RPAH Diabetes Centre between routine clinic visits by sending diabetes-related questions via an SMS portal and receive a reply within one business day.
Intervention code [1] 326253 0
Treatment: Other
Comparator / control treatment
All participants will complete the T1-DDS score, PAID-5 score, DES-SF score, DSAS-1 score at baseline to six-months.

Strategy A – Current standard of care (Quarterly - once every 3 months)
• Quarterly in-person clinic appointments at the Diabetes Centre or via telehealth (with Endocrinologist and Diabetes Educator) for review of glycaemia, routine pathology test results, complication screening and treatment adjustment
• Dietary review/education with the Diabetes Centre Dietitian (as required)
• Provision of a personal blood glucose monitor (or an alternative monitoring modality – CGM or flash glucose monitoring) for self-monitoring of glycaemia at home
Control group
Active

Outcomes
Primary outcome [1] 334971 0
Feasibility of interactive, SMS-support based program in T1DM clinic population defined bu retention to the program assessed by study specific questionnaires.
Timepoint [1] 334971 0
Comparison of questionnaires from Randomisation to Six months completion visit, assessed at randomisation and at 6 months post randomisation.
Secondary outcome [1] 422597 0
Comparative assessment of change in Type 1 Diabetes Distress Score (T1-DDS) score in those who received the interactive, SMS-support based program vs those who received standard of care after 6 months of follow-up. Change in powerlessness scores will be compared.
Timepoint [1] 422597 0
Initial (pre-intervention)
Six months (End of intervention)
Secondary outcome [2] 425765 0
Comparative assessment of change in PAID-5 score, in those who received the interactive, SMS-support based program vs those who received standard of care after 6 months of follow-up. Change in possible diabetes-related emotional distress will be compared.
Timepoint [2] 425765 0
Initial (pre-intervention)
Six months (End of intervention)
Secondary outcome [3] 425766 0
Comparative assessment of change in Diabetes Empowerment Scale-Short Form (DES-SF) score in those who received the interactive, SMS-support based program vs those who received standard of care after 6 months of follow-up. Change in psychosocial self-efficacy will be compared.
Timepoint [3] 425766 0
Initial (pre-intervention)
Six months (End of intervention)
Secondary outcome [4] 425767 0
Comparative assessment of change in Type 1 Diabetes Stigma Assessment Scale (DSAS-1 ) score in those who received the interactive, SMS-support based program vs those who received standard of care after 6 months of follow-up. Change in perceived treatment concerns will be compared.
Timepoint [4] 425767 0
Initial (pre-intervention)
Six months (End of intervention)
Secondary outcome [5] 426258 0
Comparative assessment of change in Type 1 Diabetes Distress Score (T1-DDS) score in those who received the interactive, SMS-support based program vs those who received standard of care after 6 months of follow-up. Change in management distress scores will be compared.
Timepoint [5] 426258 0
.Initial (pre-intervention)
Six months (End of intervention)
Secondary outcome [6] 426259 0
Comparative assessment of change in Type 1 Diabetes Distress Score (T1-DDS) score in those who received the interactive, SMS-support based program vs those who received standard of care after 6 months of follow-up. Change in hypoglycaemia distress scores will be compared.
Timepoint [6] 426259 0
Initial (pre-intervention)
Six months (End of intervention)
Secondary outcome [7] 426260 0
Comparative assessment of change in Type 1 Diabetes Distress Score (T1-DDS) score in those who received the interactive, SMS-support based program vs those who received standard of care after 6 months of follow-up. Change in negative social perceptions scores will be compared.
Timepoint [7] 426260 0
Initial (pre-intervention)
Six months (End of intervention)
Secondary outcome [8] 426262 0
Comparative assessment of change in Type 1 Diabetes Distress Score (T1-DDS) score in those who received the interactive, SMS-support based program vs those who received standard of care after 6 months of follow-up. Change in eating distress scores will be compared.
Timepoint [8] 426262 0
Initial (pre-intervention)
Six months (End of intervention)
Secondary outcome [9] 426263 0
Comparative assessment of change in Type 1 Diabetes Distress Score (T1-DDS) score in those who received the interactive, SMS-support based program vs those who received standard of care after 6 months of follow-up. Change in physician distress scores will be compared.
Timepoint [9] 426263 0
Initial (pre-intervention)
Six months (End of intervention)
Secondary outcome [10] 426264 0
Comparative assessment of change in Type 1 Diabetes Distress Score (T1-DDS) score in those who received the interactive, SMS-support based program vs those who received standard of care after 6 months of follow-up. Change in friend/family distress scores will be compared.
Timepoint [10] 426264 0
Initial (pre-intervention)
Six months (End of intervention)
Secondary outcome [11] 426265 0
Comparative assessment of change in Type 1 Diabetes Stigma Assessment Scale (DSAS-1 ) score in those who received the interactive, SMS-support based program vs those who received standard of care after 6 months of follow-up. Change in perceived treatment concerns will be compared.
Timepoint [11] 426265 0
Initial (pre-intervention)
Six months (End of intervention)
Secondary outcome [12] 426266 0
Comparative assessment of change in Type 1 Diabetes Stigma Assessment Scale (DSAS-1 ) score in those who received the interactive, SMS-support based program vs those who received standard of care after 6 months of follow-up. Change in blame or judgement concerns will be compared.
Timepoint [12] 426266 0
Initial (pre-intervention)
Six months (End of intervention)
Secondary outcome [13] 426267 0
Comparative assessment of change in Type 1 Diabetes Stigma Assessment Scale (DSAS-1 ) score in those who received the interactive, SMS-support based program vs those who received standard of care after 6 months of follow-up. Change in identity concerns will be compared.
Timepoint [13] 426267 0
Initial (pre-intervention)
Six months (End of intervention)

Eligibility
Key inclusion criteria
1. Patients with type 1 diabetes.
2. Over 18 years of age.
3. Willingness to provide informed consent and willingness to participate and comply with the study requirements.
4. Access to a mobile telephone to participate in the SMS-based program.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Insufficient proficiency in English to participate in the interactive, SMS-based support program.
2. Participants with a history of a psychological illness or other conditions which may interfere with their ability to understand the study requirements.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/09/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24856 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 40503 0
2050 - Camperdown
Recruitment postcode(s) [2] 40504 0
2050 - Missenden Road

Funding & Sponsors
Funding source category [1] 314006 0
Government body
Name [1] 314006 0
Sydney Local Health District
Country [1] 314006 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Diabetes Centre
Royal Prince Alfred Hospital
Level 6 West Wing
Missenden Road
Camperdown
NSW 2050
Country
Australia
Secondary sponsor category [1] 315891 0
None
Name [1] 315891 0
None
Address [1] 315891 0
Country [1] 315891 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313143 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 313143 0
Research and Governance Office
Royal Prince Alfred Hospital
RPA Medical Centre
Suite 306
Missenden Road
Camperdown
NSW 2050
Ethics committee country [1] 313143 0
Australia
Date submitted for ethics approval [1] 313143 0
06/06/2023
Approval date [1] 313143 0
Ethics approval number [1] 313143 0

Summary
Brief summary
A six-month study comparing usual clinical care (face to face appointments every 3 months) to usual care plus an SMS-based diabetes support program.

HYPOTHESIS:
We hypothesize that an SMS-based support program (SMS4T1D) will be feasible in the RPAH Diabetes Centre type 1 diabetes population and that this SMS-based program will facilitate a greater decrease in diabetes distress than standard clinical care over a six-month period.

AIM:
The primary aim of this study is to assess the feasibility of an SMS-based, diabetes distress support program in the RPAH Diabetes Centre type 1 diabetes population. The secondary aim is to estimate the likely magnitude of change in diabetes distress associated with the SMS4T1D program. This data could then be used to inform power calculations for future studies involving the SMS-based support program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127138 0
Dr Timothy Middleton
Address 127138 0
Diabetes CentreRoyal Prince Alfred HospitalLevel 6 West WingMissenden RoadCamperdownNSW 2050
Country 127138 0
Australia
Phone 127138 0
+61 0295155884
Fax 127138 0
Email 127138 0
timothy.middleton@health.nsw.gov.au
Contact person for public queries
Name 127139 0
Ms Amanda Gauld
Address 127139 0
Diabetes CentreRoyal Prince Alfred HospitalLevel 6 West WingMissenden RoadCamperdownNSW 2050
Country 127139 0
Australia
Phone 127139 0
+61 0295155888
Fax 127139 0
Email 127139 0
amanda.gauld@health.nsw.gov.au
Contact person for scientific queries
Name 127140 0
Dr Timothy Middleton
Address 127140 0
Diabetes CentreRoyal Prince Alfred HospitalLevel 6 West WingMissenden RoadCamperdownNSW 2050
Country 127140 0
Australia
Phone 127140 0
+61 0295155888
Fax 127140 0
Email 127140 0
timothy.middleton@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
In line with HREC conditions


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.