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Trial registered on ANZCTR


Registration number
ACTRN12616000397415
Ethics application status
Approved
Date submitted
21/03/2016
Date registered
29/03/2016
Date last updated
29/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can a primary health care intervention prevent diabetes in people with depression?
Scientific title
Can collaborative care (including lifestyle intervention) prevent progression from pre-diabetes to Type 2 diabetes in people with comorbid depression in primary health care?
Secondary ID [1] 288810 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Incident Type 2 Diabetes 298078 0
Depression 298079 0
Condition category
Condition code
Metabolic and Endocrine 298241 298241 0 0
Diabetes
Mental Health 298242 298242 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Collaborative care
Collaborative care includes the use of both the Chronic Disease Management items (for pre-diabetes) and the GP Mental Health Treatment items (for depression) to prepare two separate but integrated, concurrent care plans.
1. GP Mental Health Treatment Plan for Depression
The MBS (Medicare Benefits Schedule) items provide a structured framework for GPs to undertake early intervention, assessment and management of patients with mental disorders, as well as providing referral pathways to clinical psychologists, registered psychologists, and appropriately trained social workers and occupational therapists.
*Psychological Services
Eligible participants may be offered referrals for up to 10 individual services per calendar year. These will be used to assess and treat depression, and to identify and modify maladaptive behaviours (healthy behaviour modification counselling). Patients refusing to see the clinical psychologist will be offered counselling by the study GP as per usual care. The GP will complete the Mental Health Care Plan and refer the patient to the psychologist. The psychologist is required to send a report to the GP to document progress after 6 sessions and then the GP will write another referral for a further 4 sessions if deemed necessary.
2. Chronic Disease Management items for Pre-diabetes
There are four relevant Chronic Disease Management items that provide rebates for study GPs to manage the ‘pre-diabetes’ by preparing, coordinating, reviewing or contributing to Chronic Disease Management plans.
*Allied Health Services (Exercise Physiologists)
A Medicare rebate is available for a maximum of 5 individual services per calendar year. Accredited exercise physiologists have the ability to combine general nutritional principles with exercise advice to increase the effectiveness of their health and wellbeing interventions, especially for weight loss.

Participants will be encouraged to achieve a 5% reduction in weight per calendar year, and be advised to monitor and record their own weight weekly to promote weight-loss by the study GP. The GP will communicate this goal to the exercise physiologist, who is required to send a report to the GP to document progress after 5 sessions. Participants who smoke will be encouraged to discuss smoking cessation program options with the GP, given the excess risk of diabetes associated with active smoking.
Intervention code [1] 294263 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297734 0
Incident type 2 diabetes assessed by fasting plasma glucose greater than or equal to 7.0mmol/L and/or HbA1c greater than or equal to 6.5%
Timepoint [1] 297734 0
Approximately 12 weeks post intervention start
Secondary outcome [1] 322062 0
Feasibility of conducting a large, full-scale study assessed by quantitative data (screening, recruitment, retention rates) and qualitative data (semi-structured interviews approach lasting 30 to 45 minutes)
Timepoint [1] 322062 0
Approximately 12 weeks post intervention start

Eligibility
Key inclusion criteria
We will include participants meeting all of the following criteria:
1. Give freely written informed consent
2. Aged 40 to 74 years; the arbitrary lower age limit was chosen because of the sharp rise in the prevalence and incidence of diabetes in middle-aged Australians. The arbitrary upper age limit of 74 years was chosen because of the sharp rise in deaths in Australians aged 75 years or older
3. At least overweight defined by body mass index greater than or equal to 25 kg/m2 computed from measured height and weight
4. Confirmed pre-diabetes defined by impaired fasting glucose (IFG) (FPG levels plasma glucose levels 5.6–6.9mmol/L), or impaired glucose tolerance (IGT) (2-h PG Oral Glucose Tolerance Test [OGTT] levels of 7.8–11.0mmol/L), or HbA1c levels 5.7–6.4% according to the American Diabetes Association (ADA) criteria; pre-diabetes patients treated with Metformin are eligible
5. Clinically significant depression (using scores greater than or equal to 10 for moderate to severe symptoms) with the Patient Health Questionnaire-9 (PHQ-9)
6. Be at either (1) pre-contemplation, (2) contemplation, or (3) preparation stage of readiness to lose weight using the following question and response options based on the Prochaska Stage of Behavior Change model
Minimum age
40 Years
Maximum age
74 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Diabetes (type 1 or monogenic or type 2 or gestational diabetes) determined by self-report (doctor diagnosis or prescriptions for anti-diabetes medications)
2. Current or previous psychotic symptoms by standard medical history/self-report
3. Currently receiving treatment for breast, liver cancer or other malignancy, which could affect compliance with the protocol or interpretation of study results. Non-melanoma skin cancer(s) treated with curative intent are eligible
4. Unable to communicate effectively in English judged by the Investigator during face-to-face or telephone contact to screen for study eligibility
5. Current or planned pregnancy

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 293171 0
Self funded/Unfunded
Name [1] 293171 0
Not applicable
Address [1] 293171 0
Not applicable
Country [1] 293171 0
Primary sponsor type
University
Name
Western Sydney University
Address
Western Sydney University
Locked Bag 1797 Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 291965 0
None
Name [1] 291965 0
Address [1] 291965 0
Country [1] 291965 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294660 0
Human Research Ethics Committee at Western Sydney University
Ethics committee address [1] 294660 0
Ethics committee country [1] 294660 0
Australia
Date submitted for ethics approval [1] 294660 0
15/09/2015
Approval date [1] 294660 0
14/10/2015
Ethics approval number [1] 294660 0
H11321

Summary
Brief summary
Approval # H11321
Approved by the Human Research Ethics Committee at Western Sydney University

Type 2 diabetes (T2D) is an increasing health and economic burden in Australia that is frequently associated with depression and psychological distress. The annual incidence of T2D in Australia could be higher than 10% for adults with depression who have impaired glucose regulation (‘pre-diabetes’). Lifestyle programs aimed at achieving and maintaining a healthy weight are recommended for the primary prevention of T2D, especially for people with pre-diabetes. Lifestyle guidelines, based on findings of several large-scale clinical trials that excluded people with prevalent psychopathology, cannot be generalised to people with depression, who are least likely to engage in or adhere to healthy lifestyle recommendations and may be taking diabetogenic medications (e.g. some anti-depressants). Depression presents a major barrier to effective and sustained healthy lifestyle changes (especially exercise) that needs to be addressed to prevent T2D in this high-risk population group. While both collaborative, multidisciplinary care (‘team-based care’) and lifestyle programs are known to be effective interventions for depression treatment and diabetes prevention, respectively, there is a lack of information on how to effectively prevent T2D in community-based patients with co-morbid depression and pre-diabetes in the Australian primary health care system.

Specific aims
1.To provide preliminary evidence on the effectiveness of collaborative, multidisciplinary health services covered by the Medicare Benefits Schedule (MBS) for preventing T2D in community-based patients with co-morbid depression and pre-diabetes (DPD care) compared with usual general practitioner (GP) care
2.To assess the feasibility of conducting a large, full-scale study
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64538 0
Dr Evan Atlantis
Address 64538 0
Western Sydney University
Locked Bag 1797 Penrith NSW 2751 Australia
Country 64538 0
Australia
Phone 64538 0
+61 2 4620 3263
Fax 64538 0
Email 64538 0
E.Atlantis@westernsydney.edu.au
Contact person for public queries
Name 64539 0
Dr Evan Atlantis
Address 64539 0
Western Sydney University
Locked Bag 1797 Penrith NSW 2751 Australia
Country 64539 0
Australia
Phone 64539 0
+61 2 4620 3263
Fax 64539 0
Email 64539 0
E.Atlantis@westernsydney.edu.au
Contact person for scientific queries
Name 64540 0
Dr Evan Atlantis
Address 64540 0
Western Sydney University
Locked Bag 1797 Penrith NSW 2751 Australia
Country 64540 0
Australia
Phone 64540 0
+61 2 4620 3263
Fax 64540 0
Email 64540 0
E.Atlantis@westernsydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary