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Trial registered on ANZCTR


Registration number
ACTRN12619000892112
Ethics application status
Approved
Date submitted
7/06/2019
Date registered
26/06/2019
Date last updated
21/08/2019
Date data sharing statement initially provided
26/06/2019
Date results information initially provided
26/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Shared Medical Appointments for Type 2 Diabetes
Scientific title
Shared Medical Appointments for Type 2 Diabetes - a randomised controlled feasibility study
Secondary ID [1] 298440 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 313174 0
Condition category
Condition code
Metabolic and Endocrine 311634 311634 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a programmed Shared Medical Appointment program (pSMAs) with mindfulness.The intervention involves six 2 hour pSMAs, delivered at Western Sydney Integrative Health by a GP, facilitator (allied health professional), documenter and a meditation teacher. The overall duration and frequency of the program is six fortnightly pSMAs. Educational content will include:
• Overall management of diabetes and importance of lifestyle modifications;
• Healthy eating for diabetes and weight loss;
• Physical activity;
• Exploring and overcoming barriers to lifestyle changes; and
• Supporting psychological wellbeing.

Participants are encouraged to set their own lifestyle goals based on the RACGP handbook on General Practice Management of Type 2 Diabetes. Key goals will include weight loss of 5%, as improvements in weight have a significant impact on glycaemic control. The mindfulness component will be delivered by an experienced meditation teacher and will consist of 15-20 minutes of guided mindfulness meditation and informed by previous RCTs on mindfulness for weight loss. The pSMAs will be complemented by a workbook for reference and recording goals, and home mindfulness practice exercises.

Typically, SMAs involve 10-12 participants per group. The schedule for pSMAs follows:
Introduction and warm-up (facilitator only):5-10 minutes; Structured educational session (facilitator and allied health professional): 30 minutes; Mindfulness component: 15-20 minutes
Individual GP consultations: 50-60 minutes. 10-12 individual GP consultations will be conducted over 50-60 minutes with about 5 minutes consultation per participant, in a group setting.Participants ask questions of the GP that they would ask of any GP during a medical consultation about their diabetes. This may include: interpretation of blood test results and physical examination findings; questions about medications; lifestyle advice; management of stress.
For the home mindfulness practice, there is no prescribed time but participants are sent a weekly reminder and are encouraged to meditate as per their preference. A daily meditation is suggested but the duration is up to the participant.
Intervention code [1] 314684 0
Behaviour
Intervention code [2] 314743 0
Lifestyle
Comparator / control treatment
Participants referred to the control group will receive usual care only, defined as care as provided by their usual GP. They will also be encouraged to register for the GetHealthyNSW program, which is a free telephone-based lifestyle coaching service, and to use the free Smiling Mind mindfulness meditation app regularly.
Control group
Active

Outcomes
Primary outcome [1] 320334 0
Recruitment rate measured as number of participants recruited over the duration of the recruitment period, and it will include a conversion rate (number of enrolments/number of enquiries) from data from recruitment database..
Timepoint [1] 320334 0
at the close of recruitment
Primary outcome [2] 320420 0
Retention rates calculated as the number of patients who complete all study procedures/number of participants who enrolled,
Timepoint [2] 320420 0
at the close of the study (after all study follow-up has been completed)
Primary outcome [3] 320421 0
Acceptability of trial procedures measured through a custom-designed exit survey which is administered through Redcap.
Timepoint [3] 320421 0
after the completion of all study procedures
Secondary outcome [1] 371270 0
Difference between groups for glycemic control by HbA1c. HbA1c is assessed by blood draw.
Timepoint [1] 371270 0
baseline and 3 months post intervention commencement.
Secondary outcome [2] 371515 0
Difference between groups for fasting lipids by pathology test (assessed by blood draw)
Timepoint [2] 371515 0
baseline and 3 months post intervention commencement.
Secondary outcome [3] 371516 0
Difference between groups for quality of life by Problem Areas in Diabetes ( PAID).
Timepoint [3] 371516 0
baseline and 3 months post intervention commencement.
Secondary outcome [4] 371517 0
Difference between groups for patient activation by Patient activation measure questionnaire
Timepoint [4] 371517 0
baseline and 3 months post intervention commencement.
Secondary outcome [5] 371518 0
Difference between groups for psychological levels by State Trait Anxiety Index
Timepoint [5] 371518 0
baseline and 3 months post intervention commencement.
Secondary outcome [6] 371519 0
Difference between groups for self-reported diet using 3 questions from the NSW Population Health Survey Questionnaire 2017: Nut 1b, Nut2b, and Nut13b (Vegetable intake, fruit intake, and takeaway food intake)
Timepoint [6] 371519 0
baseline and 3 months post intervention commencement.
Secondary outcome [7] 371520 0
Difference between groups for physical activity levels by using accelerometers. Physical activity includes step count, number of and minutes of physical activity per day.
Timepoint [7] 371520 0
baseline and 3 months post intervention commencement.
Secondary outcome [8] 371529 0
Difference between groups for adverse events. We use an adverse event case report form which can be self reported or completed by an investigator upon receiving a report of an adverse events. Adverse events may include pain or itching related to the glucose monitor.
Timepoint [8] 371529 0
throughout the study and also at 3 months post intervention commencement.
Secondary outcome [9] 371714 0
Difference between groups for glycemic control by continuous glucose level. Continuous glucose monitoring by the Abbott Libre Pro 14 day continuous glucose monitor.
Timepoint [9] 371714 0
baseline and 3 months post intervention commencement.
Secondary outcome [10] 371717 0
Difference between groups for lipids by anthropometric measures (weight). Body weight using medical grade electronic weighing scales
Timepoint [10] 371717 0
baseline and 3 months post intervention commencement.
Secondary outcome [11] 371718 0
Difference between groups for lipids by anthropometric measures (waist circumference,) .Waist circumference using medical grade measuring tape
Timepoint [11] 371718 0
baseline and 3 months post intervention commencement.
Secondary outcome [12] 371720 0
Difference between groups for quality of life by Patient-Reported Outcomes Measurement Information System (PROMIS - 29) questionnaire
Timepoint [12] 371720 0
baseline and 3 months post intervention commencement.
Secondary outcome [13] 371721 0
Difference between groups for psychological levels by Beck Depression Inventory
Timepoint [13] 371721 0
baseline and 3 months post intervention commencement.
Secondary outcome [14] 371722 0
Difference between groups for lipids by anthropometric measures (hip circumference) .Hip circumference using medical grade measuring tape.
Timepoint [14] 371722 0
baseline and 3 months post intervention commencement.
Secondary outcome [15] 371723 0
Difference between groups for lipids by BMI index. BMI is calculated using weight/(height squared). Weight is measured using medical grade electronic weighing scales, with the patient in light clothing. Height is measured using a fixed stadiometer.
Timepoint [15] 371723 0
baseline and 3 months post intervention commencement.
Secondary outcome [16] 371724 0
Adherence rates by the number of SMAs attended per participant/number of participants in the SMA group from data from recruitment database and the exit survey which is administered through Redcap.(This is an additional primary outcome).
Timepoint [16] 371724 0
At the close of the study intervention period

Eligibility
Key inclusion criteria
• Age > 21;
• Living in Western Sydney;
• Diagnosed with Type 2 diabetes (HbA1c > 6.5% OR fasting blood glucose > 7mmol/L) within the past 12 months; will need to be confirmed with a repeat test if there is no HbA1c result within the past 3 months;
• Has a smartphone compatible for the use of the FreeStyle LibreLink App (NFC enabled phones running Android 5.0 or higher, or with iPhone 7 or higher, running iOS 11, or higher);
Minimum age
21 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unable to attend for SMAs;
• Pregnant or planning pregnancy in next 3 months;
• Serious medical or psychological conditions (e.g., metastatic cancer, poorly controlled schizophrenia);
• Not fluent in English (unable to follow conversations and instructions in English and unable to read English);
• Known allergy to medical adhesives.

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)
The research assistant will allocate participants by selecting the next consecutively number sealed opaque envelope that contains the allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be created using a computer program by a researcher external to the research team. Permuted blocks of four will be used. This researcher will hold the randomisation sequence and will create a series of 24 consecutively numbered sealed opaque envelopes that will contain the ID number and allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Recruitment, retention and adherence rates are presented with descriptive statistics. Mixed model ANOVAs will be used to determine within-group differences for continuous outcomes between baseline and 3 months, and ANCOVAs for between-group differences for continuous outcomes with baseline score as a co-variate. Intention-to-treat analysis will be used.

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
Recruitment postcode(s) [1] 26735 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 302986 0
University
Name [1] 302986 0
Western Sydney University Women’s Research Fellowship 2019
Address [1] 302986 0
Locked Bag 1797, Penrith 2751, NSW
Country [1] 302986 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Locked Bag 1797, Penrith 2751, NSW
Country
Australia
Secondary sponsor category [1] 302946 0
None
Name [1] 302946 0
Address [1] 302946 0
Country [1] 302946 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303537 0
Western Sydney University
Ethics committee address [1] 303537 0
Locked Bag 1797, Penrith 2751, NSW
Ethics committee country [1] 303537 0
Australia
Date submitted for ethics approval [1] 303537 0
Approval date [1] 303537 0
16/11/2018
Ethics approval number [1] 303537 0
H12925

Summary
Brief summary
This is a randomised controlled feasibility study. The first aim of this study is to collaborate with community and local health organisations in order to co-design a preventive program for Type 2 diabetes (T2D). The second aim is to pilot the program using a small-scale clinical trial in order to determine how feasible and acceptable it is to end users. This new information will then be used to design a larger clinical trial which will provide definitive knowledge about the effectiveness of our program in preventing and managing T2D.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94006 0
Dr Carolyn Ee
Address 94006 0
NICM Health Research Institute, Western Sydney University, Locked Bag 1797, Penrith 2751, NSW
Country 94006 0
Australia
Phone 94006 0
+61 413 319 830
Fax 94006 0
Email 94006 0
c.ee@westernsydney.edu.au
Contact person for public queries
Name 94007 0
Dr Carolyn Ee
Address 94007 0
NICM Health Research Institute, Western Sydney University, Locked Bag 1797, Penrith 2751, NSW
Country 94007 0
Australia
Phone 94007 0
+61 413 319 830
Fax 94007 0
Email 94007 0
c.ee@westernsydney.edu.au
Contact person for scientific queries
Name 94008 0
Dr Carolyn Ee
Address 94008 0
NICM Health Research Institute, Western Sydney University, Locked Bag 1797, Penrith 2751, NSW


Country 94008 0
Australia
Phone 94008 0
+61 413 319 830
Fax 94008 0
Email 94008 0
c.ee@westernsydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All laboratory specimens, evaluation forms, reports, and other records must be identified in a manner designed to maintain participant confidentiality. Clinical information will not be released without the written permission of the participant, except as necessary for monitoring and auditing by the Sponsor, its designee, Regulatory Authorities, or the HREC. The Investigator and study site staff involved with this study may not disclose or use for any purpose other than performance of the study, any data, record, or other unpublished, confidential information disclosed to those individuals for the purpose of the study. Prior written agreement from the Sponsor or its designee must be obtained for the disclosure of any said confidential information to other parties.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary