Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06113588
Registration number
NCT06113588
Ethics application status
Date submitted
21/06/2023
Date registered
2/11/2023
Date last updated
2/11/2023
Titles & IDs
Public title
Transition of Care in Type 1 Diabetes Mellitus
Query!
Scientific title
Improving Transition of Care in Type 1 Diabetes Mellitus: A Collaborative Approach
Query!
Secondary ID [1]
0
0
2022/ETH02412
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Transition
0
0
Query!
Type 1 Diabetes Mellitus
0
0
Query!
Condition category
Condition code
Metabolic and Endocrine
0
0
0
0
Query!
Diabetes
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
Description of intervention(s) / exposure
Retrospective cohort - Patients with type 1 diabetes mellitus known to Royal North Shore Hospital, who underwent transition from paediatric to adult health care from 1st January 2020-8th June 2023
Prospective cohort - Patients with type 1 diabetes mellitus known to Royal North Shore Hospital, undergoing transition from paediatric to adult health care, from 9th June 2023 onwards
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Patient self-efficacy (patient, family and staff member) relating to diabetes
Query!
Assessment method [1]
0
0
From prospective questionnaires, with higher scores indicative of higher self-efficacy
Query!
Timepoint [1]
0
0
From 9th June, 2023, ongoing for initial period of 5 years with interim sequential reviews
Query!
Primary outcome [2]
0
0
Diabetes knowledge questionnaire (patient and family member)
Query!
Assessment method [2]
0
0
From prospective questionnaires, with a single correct answer per question
Query!
Timepoint [2]
0
0
From 9th June, 2023, ongoing for initial period of 5 years with interim sequential reviews
Query!
Primary outcome [3]
0
0
Diabetes-related distress (patient and family member)
Query!
Assessment method [3]
0
0
From prospective questionnaires, with higher scores indicative of higher distress levels
Query!
Timepoint [3]
0
0
From 9th June, 2023, ongoing for initial period of 5 years with interim sequential reviews
Query!
Secondary outcome [1]
0
0
Patient medical outcomes
Query!
Assessment method [1]
0
0
HbA1c (%) over time
Query!
Timepoint [1]
0
0
From 9th June, 2023, ongoing for initial period of up to 5 years with interim sequential reviews
Query!
Secondary outcome [2]
0
0
Patient medical outcomes
Query!
Assessment method [2]
0
0
Frequency (number) of emergency department presentations
Query!
Timepoint [2]
0
0
From 9th June, 2023, ongoing for initial period of up to 5 years with interim sequential reviews
Query!
Secondary outcome [3]
0
0
Patient medical outcomes
Query!
Assessment method [3]
0
0
Percentage of patients developing diabetes complications
Query!
Timepoint [3]
0
0
From 9th June, 2023, ongoing for initial period of up to 5 years with interim sequential reviews
Query!
Eligibility
Key inclusion criteria
Adolescents who have an existing diagnosis of type 1 diabetes mellitus and who underwent
(in 2020 to 8th June, 2023) or who are undergoing (from 9th June, 2023 and subsequent
cohorts) transition from paediatric care to adult health care at Royal North Shore Hospital
and Mona Vale Community Health Centre. Adolescents with type 1 diabetes will be 16 years or
older
A family member or caregiver of the participant of the adolescent patient with type 1
diabetes mellitus
A staff member who is a member of the patient's treating diabetes team within the
paediatric diabetes service (first study visit and second study visit) and young adult
diabetes service (third study visit)
Query!
Minimum age
16
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Query!
Key exclusion criteria
There are no specific exclusion criteria
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
9/06/2023
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
9/06/2028
Query!
Actual
Query!
Sample size
Target
80
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
0
0
Royal North Shore Hospital - Sydney
Query!
Recruitment postcode(s) [1]
0
0
2065 - Sydney
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Northern Sydney and Central Coast Area Health Service
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This research project seeks to address the question of how to improve the transition of
patients with type 1 diabetes mellitus from the paediatric to the adult health service at
RNSH and Mona Vale Community Health Centre (seeking the perspectives of patients, families,
and staff)?
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT06113588
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Shihab Hameed, MBBS
Query!
Address
0
0
Royal North Shore Hospital
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06113588
Download to PDF