Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000686000
Ethics application status
Approved
Date submitted
7/08/2010
Date registered
19/08/2010
Date last updated
19/08/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of a Behavioural Program to Improve Diabetes Care and Health Outcomes in Young Adults with Type 1 Diabetes
Scientific title
Improving Treatment Adherence and Physical and Psychological Health Outcomes in Young Adults with Type 1 Diabetes: Behavioural Self-management Training vs. Stress-management Training
Secondary ID [1] 252376 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 257888 0
Condition category
Condition code
Metabolic and Endocrine 258049 258049 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1. Usual clinical care plus 9 sessions of behavioural self-management training using an applied behaviour analytic approach. Behavioural self-management training will involve daily self-monitoring of target behaviours, individual objective goal-setting, performance feedback, and behavioural consultation and problem-solving based on functional assessments. 1 x 30 min session per week for 9 weeks, administered one-on-one by a therapist with doctoral-level qualifications in psychology.

Arm 2. Usual clinical care plus 9 sessions of stress management training. Stress management training will involve daily self-monitoring of target behaviours (identical to Arm 1) and cover relaxation and stress reduction skills including diaphragmatic breathing, progressive muscle relaxation and mindfulness. 1 x 30 min session per week for 9 weeks, administered one-on-one by a therapist with doctoral-level qualifications in psychology.
Intervention code [1] 256939 0
Treatment: Other
Intervention code [2] 256940 0
Behaviour
Intervention code [3] 256941 0
Rehabilitation
Comparator / control treatment
Usual clinical care
Control group
Active

Outcomes
Primary outcome [1] 258910 0
Self-reported adherence to diabetes care regimens
Timepoint [1] 258910 0
Baseline, 3 months, 6 months, 9 months, 12 months
Primary outcome [2] 258911 0
Mental Health Inventory scores
Timepoint [2] 258911 0
Baseline, 3 months, 6 months, 9 months, 12 months
Primary outcome [3] 258912 0
Glycated haemoglobin (HbA1c), assessed using immunoassay
Timepoint [3] 258912 0
Baseline, 3 months, 6 months, 9 months, 12 months
Secondary outcome [1] 265069 0
Frequency and severity of hypoglycaemic episodes, assessed using patient self-report questionnaire
Timepoint [1] 265069 0
Baseline, 3 months, 6 months, 9 months, 12 months
Secondary outcome [2] 265070 0
Frequency of sick days, hospitalisations for diabetes-related complications (e.g., diabetic ketoacidosis) assessed via self-report and using medical records.
Timepoint [2] 265070 0
Baseline, 3 months, 6 months, 9 months, 12 months
Secondary outcome [3] 265071 0
Fasted blood lipid levels
Timepoint [3] 265071 0
Baseline, 3 months, 6 months, 9 months, 12 months
Secondary outcome [4] 265072 0
Creatinine levels, assessed by blood analysis
Timepoint [4] 265072 0
Baseline, 3 months, 6 months, 9 months, 12 months
Secondary outcome [5] 265073 0
Albumin levels, assessed by blood analysis
Timepoint [5] 265073 0
Baseline, 3 months, 6 months, 9 months, 12 months
Secondary outcome [6] 265074 0
Weight and Body Mass Index
Timepoint [6] 265074 0
Baseline, 3 months, 6 months, 9 months, 12 months

Eligibility
Key inclusion criteria
Have had a diagnosis of Type 1 diabetes for at least 12 months

Have been receiving multidisciplinary care for Type 1 diabetes for at least 12 months

Currently attending the Fremantle Hospital Young Adult Diabetes Clinic
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant;

Current participation in other clinical trials of behavioural, psychological or medical interventions for diabetes;

Current psychiatric diagnosis;

Intellectual disability

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)
Sealed opaque envelopes will be used to conceal treatment allocation prior to participants’ enrolment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised random order generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257390 0
Charities/Societies/Foundations
Name [1] 257390 0
Australian Diabetes Society
Country [1] 257390 0
Australia
Funding source category [2] 257391 0
Charities/Societies/Foundations
Name [2] 257391 0
Fremantle Hospital Medical Research Foundation
Country [2] 257391 0
Australia
Primary sponsor type
Individual
Name
Dr Melanie Burkhardt
Address
Diabetes Education Unit,
A Block, Fremantle Hospital,
Alma Street, Fremantle, WA, 6959
Country
Australia
Secondary sponsor category [1] 256645 0
Individual
Name [1] 256645 0
Professor Bu Yeap
Address [1] 256645 0
Level 2, T Block, Fremantle Hospital,
Alma Street, Fremantle, WA, 6160
Country [1] 256645 0
Australia
Other collaborator category [1] 251420 0
Individual
Name [1] 251420 0
Dr Gerry Fegan
Address [1] 251420 0
Diabetes Education Unit,
A Block, Fremantle Hospital,
Alma Street, Fremantle, WA, 6959
Country [1] 251420 0
Australia
Other collaborator category [2] 251421 0
Individual
Name [2] 251421 0
Pixie Barrie
Address [2] 251421 0
Diabetes Education Unit,
A Block, Fremantle Hospital,
Alma Street, Fremantle, WA, 6959
Country [2] 251421 0
Australia

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 31472 0
Address 31472 0
Country 31472 0
Phone 31472 0
Fax 31472 0
Email 31472 0
Contact person for public queries
Name 14719 0
Dr Melanie Burkhardt
Address 14719 0
Diabetes Education Unit
A Block, Fremantle Hospital
Alma Street, Fremantle, Western Australia, 6959

School of Nursing and Midwifery
Curtin University
Kent Street, Bentley, Western Australia, 6102
Country 14719 0
Australia
Phone 14719 0
+61 8 92662097
Fax 14719 0
+61 8 92662959
Email 14719 0
[email protected]
Contact person for scientific queries
Name 5647 0
Dr Melanie Burkhardt
Address 5647 0
Diabetes Education Unit
A Block, Fremantle Hospital
Alma Street, Fremantle, Western Australia, 6959

School of Nursing and Midwifery
Curtin University
Kent Street, Bentley, Western Australia, 6102
Country 5647 0
Australia
Phone 5647 0
+61 8 92662097
Fax 5647 0
+61 8 92662959
Email 5647 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.