Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001353189
Ethics application status
Approved
Date submitted
22/08/2019
Date registered
3/10/2019
Date last updated
3/10/2019
Date data sharing statement initially provided
3/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prevention of Diabetes Progression in Primary Care through Shared Medical Appointments
Scientific title
Preventing progression in Type 2 Diabetes through Shared Medical Appointments with pre-diabetes patients in Primary Care: A controlled trial in translation research.
Secondary ID [1] 299084 0
Nil known
Universal Trial Number (UTN)
U1111-1238-9589
Trial acronym
PreDiSMA (PREvention of DIabetes through Shared Medical Appointments)
Linked study record
Egger G, Stevens J, Voler N, Egger S. Programmed Shared Medical Appointments (pSMAs) for weight management in primary care: An exploratory study in translational research. Australian Journal of General Practice (October 2019 - in press).

Health condition
Health condition(s) or problem(s) studied:
Diabetes 314122 0
Pre-diabetes 314124 0
Condition category
Condition code
Metabolic and Endocrine 312501 312501 0 0
Diabetes
Public Health 312902 312902 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants (120 or 12 groups x 10 per group) and controls (120) from 6 Primary Care Centres in Western Sydney will attend 6 x Shared Medical Appointments with a trained Facilitator and General Practitioner over 3 months in an experiential learning model aiming to prevent the progression of, or reverse early-stage Type 2 diabetes. Participants (8-12 per group) will be provided materials on physical activity, nutrition, stress management and sleep. A pre-prepared audio-visual presentation (12-15 minutes) will precede an interactive question and answer learning session with a trained Facilitator (Practice Nurse appropriate or Allied Health Professional (AHP)) followed by individual consultations by the GP with all present contributing. Materials supplied (Participant Handbook; Eating Plan; Patient Handouts) to participants and Facilitators have been prepared in conjunction with the Australian Society of Lifestyle Medicine (ASLM). Sessions last for approximately 100 minutes with the medical consultations taking 1 hour. Sessions will be conducted fortnightly over three months. Session topics (6) include 1 introduction (explaining Pre-diabetes), 2 on physical activity; weeks 2 and 4 - aerobic exercise and strength exercise; 2 on nutrition (physical and psychological components of nutrition and 1 on Stress and Sleep. Materials have been designed especially for this study but based on our previous study of weight control and the PREVIEW study on diabetes reversal. Adherence to strategies will be checked by questionnaire at the (immediate) end of the study.
Intervention code [1] 315355 0
Prevention
Intervention code [2] 315356 0
Lifestyle
Comparator / control treatment
Controls will be randomly selected from participants within the inclusion/exclusion group who have been invited to be involved in the study. Randomisation will be carried out by Facilitators with the Project co-ordinator blinded to selection. Controls will be given usual care with their doctor (eg. regular check-ups; visits as requested etc) over the process of the trial with the offer of involvement at the end of the trial.
Control group
Active

Outcomes
Primary outcome [1] 321149 0
Changes in HbA1c levels as measured by serum assay; compared with controls
Timepoint [1] 321149 0
Immediately before and at the end of the intervention (3 months) and again 12 months post intervention commencement (primary timepoint)
Primary outcome [2] 321150 0
Body weight using standard digital scales pre and post intervention testing and again at 12 months post intervention commencement
Timepoint [2] 321150 0
Immediately before and at the end of the intervention (3 months) and again 12 months post intervention commencement (primary timepoint)
Secondary outcome [1] 374128 0
Patient satisfaction with process as measured by likert scales
Timepoint [1] 374128 0
3 months post the start of the intervention where the start is defined as date of first session.
Secondary outcome [2] 374129 0
Provider satisfaction with process as measured by likert scales
Timepoint [2] 374129 0
3 months post the start of the intervention where the start is defined as date of first session.

Eligibility
Key inclusion criteria
Age 18-65
HbA1c <6.5>5.6 and no diagnosed diabetes or HbA1C <7.0 with T2D diagnosed within 3 years, but not on diabetic medication.
Body weight/BMI (<45>24 for Caucasian and >22 for Asian and Aboriginal)
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Using insulin or metformin
Weight loss of >5% in previous 6 months
Current use of anti-obesity drugs
known cancer
Known learning difficulties
pregnancy
Presence of an eating or purging disorder

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)
Numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistics book
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
23/09/2019
Date of last participant enrolment
Anticipated
30/10/2019
Actual
Date of last data collection
Anticipated
30/10/2020
Actual
Sample size
Target
240
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 27638 0
2148 - Blacktown

Funding & Sponsors
Funding source category [1] 303623 0
Government body
Name [1] 303623 0
WENTWEST Western Sydney Primary Health Network
Country [1] 303623 0
Australia
Primary sponsor type
University
Name
NICM, Health Research Institute, University of Western Sydney
Address
158-160 Hawkesbury Rd, Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 303712 0
Charities/Societies/Foundations
Name [1] 303712 0
Australasian Society of Lifestyle Medicine (ASLM)
Address [1] 303712 0
829a High St., Thornbury Vic 3071
Country [1] 303712 0
Australia
Other collaborator category [1] 280923 0
University
Name [1] 280923 0
Southern Cross University
Address [1] 280923 0
Military Rd., East Lismore,NSW, 2480
Country [1] 280923 0
Australia
Other collaborator category [2] 280924 0
Commercial sector/Industry
Name [2] 280924 0
Lifestyle Medicine Programs P/L
Address [2] 280924 0
PO Box 157, Lismore, NSW 2480
Country [2] 280924 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304149 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [1] 304149 0
Military Rd., East Lismore NSW 2480.
Ethics committee country [1] 304149 0
Australia
Date submitted for ethics approval [1] 304149 0
10/09/2018
Approval date [1] 304149 0
20/08/2019
Ethics approval number [1] 304149 0
ECN-18-181

Summary
Brief summary
12 groups of 8-12 subjects will be chosen from 6 volunteer Western Sydney Medical Centres to attend 6 x fortnightly experiential learning sessions conducted as Programmed Shared Medical Appointments (pSMAs) in diabetes risk factor management. Participants will be selected from pre-diabetes and early diagnosed (3 years) Type 2 diabetes patients who are not on diabetic medications. The intervention will include a structured audio-visual presentation (12-15 minutes) before a discussion session with a trained facilitator (usually trained nurse or allied health professional), followed individual clinical consultations with a GP with all participants contributing. End-point outcomes (HbA1C, body weight) will be compared with standard treatment controls after 12 months. Patient and provider satisfaction with the process are secondary outcomes.
Trial website
NA
Trial related presentations / publications
Public notes
Egger G, Steven J, Volker N, Egger S. Programmed Shared Medical Appointments (pSMAs) for weight management in primary care: An exploratory study in translational research. Aus J Gen Prac (Oct 2019; in press)

Contacts
Principal investigator
Name 95966 0
Prof Garry Egger
Address 95966 0
School of Health Sciences; Southern Cross University, Military Rd., East Lismore NSW 2480.
Country 95966 0
Australia
Phone 95966 0
+61 408643914
Fax 95966 0
Email 95966 0
[email protected]
Contact person for public queries
Name 95967 0
Prof Garry Egger
Address 95967 0
School of Health Sciences; Southern Cross University, Military Rd., East Lismore NSW 2480.
Country 95967 0
Australia
Phone 95967 0
+61 408643914
Fax 95967 0
Email 95967 0
[email protected]
Contact person for scientific queries
Name 95968 0
Prof Garry Egger
Address 95968 0
School of Health Sciences; Southern Cross University, Military Rd., East Lismore NSW 2480.
Country 95968 0
Australia
Phone 95968 0
+61 408643914
Fax 95968 0
Email 95968 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All
When will data be available (start and end dates)?
No end date, available for 5 years after publication
Available to whom?
All
Available for what types of analyses?
Any
How or where can data be obtained?
By emailing the principal investigator ([email protected])


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.