Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000983808
Ethics application status
Approved
Date submitted
11/09/2012
Date registered
12/09/2012
Date last updated
1/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Newly Diagnosed Type 1 Diabetes Ambulatory Care Service Trial
Scientific title
The effect of ambulatory care versus standard inpatient care on clinical indicators, knowledge, patient satisfaction, coping and quality of life in children and adolescents newly diagnosed with Type 1 Diabetes
Secondary ID [1] 281214 0
RMS 2031 (Princess Margaret Hospital, Western Australia)
Universal Trial Number (UTN)
Trial acronym
DACS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes Mellitus 287404 0
Condition category
Condition code
Metabolic and Endocrine 287732 287732 0 0
Diabetes
Public Health 287742 287742 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ambulatory care - patient will be discharged on day 2 following diagnosis. A nurse will visit to assist with/supervise morning and evening insulin administration for 48 hours following discharge. A diabetes educator and a dietitian will visit on two occasions and a diabetes educator and a social worker will visit on one occasion over the two week period following discharge to complete education and pyschosocial review that would normally be done during inpatient hospital stay. Each visit will be approximately 2 hours in duration. Phone support will be available 24 hours a day to all ambulatory care patients for the two week period following discharge.
Intervention code [1] 285681 0
Other interventions
Comparator / control treatment
Children and adolescents newly diagnosed with type 1 diabetes remaining in hospital for an average of 5-6 days while education and assessment are completed.
Control group
Active

Outcomes
Primary outcome [1] 287972 0
Mean HbA1c levels (blood test)
Timepoint [1] 287972 0
3, 6, 9 and 12 months post-diagnosis
Primary outcome [2] 287977 0
Incidence of moderate and severe hypoglycaemia (patient report, clinical notes in the case of hospitalisation)
Timepoint [2] 287977 0
In the 12 months following diagnosis
Primary outcome [3] 287978 0
Mean readmission rate and hospital bed days (clinical notes)
Timepoint [3] 287978 0
In the 12 months following diagnosis
Secondary outcome [1] 299163 0
Patient satisfaction score for parents (calculated from 28 question Patient Satisfaction questionnaire developed specifically for this project; uses 5-point Likert scale)
Timepoint [1] 299163 0
Immediately following discharge (controls) or completion of home-based education (intervention group)
Secondary outcome [2] 299172 0
Diabetes knowledge score for parents (calculated from validated 15 multiple choice question Diabetes Knowledge questionnaire)
Timepoint [2] 299172 0
3 and 9 months post-diagnosis
Secondary outcome [3] 299173 0
Quality of Life score for children aged 10 years and over (calculated from validated 52 question Quality of Life Questionnaire; uses 5-point rating scale)
Timepoint [3] 299173 0
3 and 9 months post-diagnosis
Secondary outcome [4] 299174 0
Adjustment and Coping score for adolescents aged 12 years and over and for parents (calculated from validated Problem Areas in Diabetes Questionnaire - there are separate versions for adolescents, parents of adolescents and parents of younger children; all use a 6-point rating scale)
Timepoint [4] 299174 0
3 and 9 months post-diagnosis

Eligibility
Key inclusion criteria
Aged 3-16 years; living within home visit boundaries for Princess Margaret Hospital in the Home service; no immediate family member with existing type 1 diabetes; do not require interpreter; medically suitable for early discharge; no hazards or risks to preclude home visits; no complex social issues or family instability
Minimum age
3 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not aged 3-16 years; living outside home visit boundaries for Princess Margaret Hospital in the Home service; immediate family member with existing type 1 diabetes; requires interpreter; medically unsuitable for early discharge; idenitifed hazards or risks that preclude home visits; complex social issues or family instability

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/09/2012
Actual
18/09/2012
Date of last participant enrolment
Anticipated
Actual
22/12/2014
Date of last data collection
Anticipated
Actual
20/01/2016
Sample size
Target
60
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 285992 0
Government body
Name [1] 285992 0
WA Department of Health
Country [1] 285992 0
Australia
Funding source category [2] 300303 0
Charities/Societies/Foundations
Name [2] 300303 0
Princess Margaret Hospital Foundation
Country [2] 300303 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Elizabeth Davis
Address
Diabetes and Endocrinology
Princess Margaret Hospital for Children
Cnr Hamilton Street & Roberts Road, SUBIACO WA 6008
Country
Australia
Secondary sponsor category [1] 284811 0
Hospital
Name [1] 284811 0
Princess Margaret Hospital for Children
Address [1] 284811 0
Cnr Hamilton Street & Roberts Road, SUBIACO WA 6008
Country [1] 284811 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288039 0
Princess Margaret Hospital for Children Ethics Committee
Ethics committee address [1] 288039 0
Ethics committee country [1] 288039 0
Australia
Date submitted for ethics approval [1] 288039 0
Approval date [1] 288039 0
05/07/2012
Ethics approval number [1] 288039 0
1990/EP

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

Contacts
Principal investigator
Name 34701 0
Prof Prof Elizabeth Davis
Address 34701 0
Princess Margaret Hospital for Children
Roberts Road
Subiaco WA 6008
Country 34701 0
Australia
Phone 34701 0
+61 8 8934 8222
Fax 34701 0
Email 34701 0
[email protected]
Contact person for public queries
Name 17948 0
Helen Clapin
Address 17948 0
Diabetes and Endocrinology
Princess Margaret Hospital for Children
Cnr Hamilton Street & Roberts Road, SUBIACO WA 6008
Country 17948 0
Australia
Phone 17948 0
+61 8 9340 3101
Fax 17948 0
Email 17948 0
[email protected]
Contact person for scientific queries
Name 8876 0
Associate Professor Elizabeth Davis
Address 8876 0
Diabetes and Endocrinology
Princess Margaret Hospital for Children
Cnr Hamilton Street & Roberts Road, SUBIACO WA 6008
Country 8876 0
Australia
Phone 8876 0
+61 8 9340 8090
Fax 8876 0
Email 8876 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.