Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000977673p
Ethics application status
Submitted, not yet approved
Date submitted
22/08/2023
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
Type 1 Diabetes Distress Questionnaire, observational study for people living with type 1 diabetes.
Scientific title
Detection and understanding of diabetes related distress in people living with type 1 diabetes
Secondary ID [1] 310431 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 331203 0
Distress 331204 0
Condition category
Condition code
Metabolic and Endocrine 327974 327974 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
An observational, cross-sectional study of diabetes distress, conducted at the Royal Prince Alfred Hospital (RPAH) Diabetes Centre. The study population comprises the subgroup of patients with a diagnosis of type 1 diabetes mellitus.

Participants complete the T1-DDS 28-item online questionnaire one-time in the week prior to their scheduled Diabetes Centre clinic appointment.

Participants will complete their routine clinic appointment with their diabetes educator and endocrinologist. At the end of that consultation, on this one occasion:
1. The participant will complete the three item post-consultation patient questionnaire.
2. The diabetes educator will complete the three item-post-consultation educator questionnaire and
3. The treating endocrinologist will complete the single item-post consultation endocrinologist questionnaire.
Intervention code [1] 326832 0
Early Detection / Screening
Comparator / control treatment
Participants will complete their routine clinic appointment with their diabetes educator and endocrinologist. At the end of that consultation:
1. The diabetes educator will complete the three item-post-consultation educator questionnaire and
2. The treating endocrinologist will complete the single item-post consultation endocrinologist questionnaire.
There will be no specific control group of people with type 1 diabetes that do not undertake the T1-DDS 28-item questionnaire or the post-consultation patient questionnaire.
Control group
Active

Outcomes
Primary outcome [1] 335828 0
Prevalence of Diabetes Distress within the RPAH Diabetes Centre according to the T1-DDS
Timepoint [1] 335828 0
Assessed at the conclusion of the study.
Secondary outcome [1] 425823 0
Correlation between participant reported diabetes distress and clinician (diabetes educator / endocrinologist) assessment of participant distress at time of consultation.
Timepoint [1] 425823 0
Assessed at the conclusion of the study.

Eligibility
Key inclusion criteria
Key inclusion
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.
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 complete the T1-DDS instrument and post-clinic questionnaire.
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
Screening
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
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
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25428 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 41170 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 314638 0
Government body
Name [1] 314638 0
Sydney Local Health District
Country [1] 314638 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] 316602 0
None
Name [1] 316602 0
Address [1] 316602 0
Country [1] 316602 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313659 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 313659 0
Research and Governance Office
Royal Prince Alfred Hospital
RPAH Medical Centre
Suite 306
Missenden Road
Camperdown
NSW 2050
Ethics committee country [1] 313659 0
Australia
Date submitted for ethics approval [1] 313659 0
06/06/2023
Approval date [1] 313659 0
Ethics approval number [1] 313659 0

Summary
Brief summary
Patients complete a validated questionnaire prior to a scheduled clinic appointment followed by another questionnaire after their appointment. The diabetes educator and endocrinologist will also complete a questionnaire after the appointment.

HYPOTHESIS:
As a piece of observational research, our goals are to:
(i) determine the prevalence of diabetes distress within the type 1 diabetes population of the RPAH Diabetes Centre and,
(ii) to establish whether there is a correlation between diabetes distress (measured using the T1 DDS questionnaire) and level of glycaemic control (HbA1c) in our patients.

AIM:
The primary aim of this study is to determine the prevalence of diabetes distress (as measured by the T1-DDS) in a representative sample of the type 1 diabetes population within the RPAH Diabetes Centre. We also wish to establish whether there is a correlation between diabetes distress and level of glycaemic control.

Secondary aims of this study include assessing diabetes distress within specific subgroups of patients including:
(i) those aged 18-40 years vs those aged >40 years,
(ii) those with recently diagnosed diabetes vs those with longstanding diabetes,
(iii) those treated with insulin pump (CSII) vs those treated with multiple daily injections of insulin (MDI), and
(iv) those of normal weight vs those who are overweight/obese.
Additionally, we wish to assess the ability of health professionals (namely, diabetes educators and endocrinologists) to ascertain levels of diabetes distress in patients during routine consultation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128914 0
Dr Timothy Middelton
Address 128914 0
Diabetes CentreRoyal Prince Alfred HospitalLevel 6 West WingMissenden RoadCamperdownNSW 2050
Country 128914 0
Australia
Phone 128914 0
+61 0295155884
Fax 128914 0
Email 128914 0
[email protected]
Contact person for public queries
Name 128915 0
Ms Amanda Gauld
Address 128915 0
Diabetes CentreRoyal Prince Alfred HospitalLevel 6 West WingMissenden RoadCamperdownNSW 2050
Country 128915 0
Australia
Phone 128915 0
+61 0295155888
Fax 128915 0
Email 128915 0
[email protected]
Contact person for scientific queries
Name 128916 0
Dr Timothy Middelton
Address 128916 0
Diabetes CentreRoyal Prince Alfred HospitalLevel 6 West WingMissenden RoadCamperdownNSW 2050
Country 128916 0
Australia
Phone 128916 0
+61 0295155884
Fax 128916 0
Email 128916 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
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.