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Trial registered on ANZCTR


Registration number
ACTRN12624000957594
Ethics application status
Approved
Date submitted
24/01/2023
Date registered
7/08/2024
Date last updated
1/11/2024
Date data sharing statement initially provided
7/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Wearables Integrated Technology to support healthy behaviours in people with Type 2 Diabetes (Wear- IT): Study protocol for a cluster randomised controlled trial
Scientific title
Effect of Wearables Integrated Technology on HbA1c level in people with Type 2 Diabetes (Wear- IT): Study protocol for a cluster randomised controlled trial
Secondary ID [1] 308587 0
Nil
Universal Trial Number (UTN)
Trial acronym
Wear-IT (Wearables Integrated Technology)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 328450 0
Condition category
Condition code
Metabolic and Endocrine 325483 325483 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in this group will receive usual care, plus the Wear-IT intervention. Those attending the usual care practices will receive standard care. An 8-week self-management care plan, incorporating wearable devices, will be provided to patients in the intervention group. Outcomes will be assessed 6- and 12-months post-randomisation.

The program will include:

Initial Consultation (Care plan and goal setting through CareMonitor). Practice nurses will invite consenting patients to attend a face-to-face 45 minute consultation following practice randomisation and intervention training. Patients will work with their care team to develop a care plan using CareMonitor, including individualised target ranges for diet, exercise, Body Mass Index, Cigarette consumption, alcohol consumption, HbA1c, lipids and blood pressure. This will enable patients to monitor their own targets and behaviours through their wearable devices. The following will be tracked using wearable devices:
• Physical activity and exercise: Individual patient activity goals may include reducing sedentary behaviour and increasing anaerobic or resistance exercise, in line with best-evidence guidelines. Patients will be able to access daily and weekly summaries of their physical activity and exercise goal progress.
• Dietary intake: Over a two-week period, the flash glucometer will provide real-time feedback to patients on their blood glucose levels including post-prandial elevation. Patients will be prompted to consider the dietary cause of the variation to their blood glucose and provided with strategies to reduce the likelihood of this occurring again. Blood glucose can be monitored via daily or weekly summaries and as time in target blood glucose range.
• Blood pressure: Periodic monitoring of blood pressure will enable the care team to assess blood pressure control and response leading up to an appointment or after a change in therapy. Patients with elevated blood pressure during periodic monitoring will be prompted to consult their care plan within CareMonitor and ensure they are adhering to their therapeutic and medication recommendations.

The practice nurse will guide patients in downloading and using the CareMonitor app via their smartphone, tablet or smart device. Patients will be supported by the practice nurse to link the CareMonitor app with the wearables provided for the study and demonstrate their use. Provided wearables will include: (i) a physical activity monitor to track physical activity; (ii) a glucose monitor to periodically track blood glucose levels; and (iii) a blood pressure monitor to periodically track blood pressure. While some patients may already use a physical activity monitor, they will be encouraged to wear the study-provided monitor to standardise data. The practice nurse will help the patient set evidence-based individual activity and treatment goals, which will be reviewed and endorsed by the GP.

Weeks 1-4 (Remote patient intervention). The intervention wearable devices will be used in combination to deliver a comprehensive assessment of health behaviour and diabetes control over a period of 4 weeks.
• Patients will be asked to commence wearing their physical activity monitor immediately and throughout the 4-week period. Patients will be encouraged to monitor physical activity continuously over the intervention period and will access daily and/or weekly summaries to assess if they are meeting their goals.
• Patients will be asked to commence blood pressure monitoring on day 5 of the intervention period and be asked to record it in the morning and evening for 7 continuous days as per Heart Foundation advice on home blood pressure monitoring
• Patients will be asked to commence their continuous blood glucose monitoring at the start of week 3 for a 2-week period. The blood glucose device sits on top of the skin and continuously monitors glucose levels. These devices are disposable, expiring after 2 weeks of use.
• Patients will be periodically prompted to watch brief educational videos about managing their diabetes (e.g., “Importance of blood pressure and diabetes”). These videos were designed by Western Sydney Diabetes (study partners) and repurposed for the study. They are not a readily available resource.

Follow-up Consultation (Review and update of care plan if needed). The patient will be invited to return for a 30 minute with the practice nurse, and review by their GP. This consultation will involve reviewing the patient’s data from their wearable devices and assess whether they have been meeting their care goals. Goals will be updated as needed to assist patients in achieving these. The care team will discuss potential ways to improve their physical activity, glucose levels and blood pressure. This may include a medication review if considered necessary by their GP.

Weeks 5-8 (Remote patient intervention). The patient will repeat the intervention as per weeks 1-4, with the implemented changes as discussed in their follow-up consultation. Patients will be able to see how these changes impact their wearable outputs. Patients will be informed they can book a 30 minute follow-up appointment with their care team if they have further questions about the changes to their care plan.
Intervention code [1] 325030 0
Behaviour
Intervention code [2] 325031 0
Lifestyle
Intervention code [3] 328968 0
Treatment: Devices
Comparator / control treatment
The usual care group will receive standard care with involvement from primary care providers, which may include medication prescription, medication review and advice about diet and exercise during consultations.
Control group
Active

Outcomes
Primary outcome [1] 333331 0
HbA1c: Mean % HbA1c level, for all patients, will be collected via pathology testing.
Timepoint [1] 333331 0
Baseline and at 6- (primary timepoint) and 12-months follow-ups.
Secondary outcome [1] 416664 0
Low-density lipoprotein cholesterol (LDL-C)
- Data will determine the proportion of patients with a LDL-C< 2.0mmol/L. Low-density lipoprotein cholesterol (LDL-C) will be assessed via pathology testing.
Timepoint [1] 416664 0
Baseline and at 6- and 12-months follow-ups
Secondary outcome [2] 416702 0
Cost-effectiveness
- Hospital usage, the frequency and mode of consultations and Medicare Benefit Scheme (MBS) data will be extracted from medical records. Valuation of health care services and items will be based on published data such as that available through MBS item numbers and the Independent Hospital Pricing Authority. Resources (including time) used to implement the intervention will also be collected throughout the trial. Resources such as software will be valued at appropriate market or labour rates. Quality-adjusted life years (QALY) will be the primary outcome used in the cost-effectiveness analysis, derived from the SF-6D utility index score obtained from the SF-36 using standard methods.
Timepoint [2] 416702 0
Baseline and at 6- and 12-months follow-ups
Secondary outcome [3] 437115 0
Smoking
- Patients will be asked about their smoking status in the patient survey. This item has been previously used in the New South Wales Health Survey [1].

1. Centre for Epidemiology and Research. 2010 Report on Adult Health from the
New South Wales Population Health Survey. Sydney: NSW Department of Health, 2011.
Timepoint [3] 437115 0
Baseline and at 6- and 12-months follow-ups
Secondary outcome [4] 437116 0
Diabetes Self-Management
- The 16-item Diabetes Self-Management Questionnaire (DSMQ) will assess patients diabetes-related self-care over the past 8 weeks.
Timepoint [4] 437116 0
Baseline and at 6- and 12-months follow-ups
Secondary outcome [5] 437117 0
Patient Activation
- The 13-item Patient Activation Measure (PAM) is a validated patient-reported outcome measure that assesses a patient's knowledge, skills, and confidence in self-managing their own health.
Timepoint [5] 437117 0
Baseline and at 6- and 12-months follow-ups
Secondary outcome [6] 437983 0
Blood Pressure
- Data on blood pressure reading of less than or equal to 140/90 mmHg (130/80 mmHg if albuminuria/ proteinuria present).

Blood pressure will be assessed using most recent data recorded in medical record at the follow-up timepoint.
Timepoint [6] 437983 0
Baseline and at 6- and 12-months follow-ups
Secondary outcome [7] 437984 0
Quality of Life scores (SF36 V2)
- The SF-36 measures how often respondents have experienced problems over the last 4 weeks, across eight domains of wellbeing. It provides two summary scores: Physical Component and Mental Component. Scores from 0 to 100 are calculated for each subscale with higher scores representing better health.
Timepoint [7] 437984 0
Baseline and at 6- and 12-months follow-ups
Secondary outcome [8] 437985 0
Alcohol consumption
- Measured using the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) in the patient survey.
Timepoint [8] 437985 0
Baseline and at 6- and 12-months follow-ups.
Secondary outcome [9] 437986 0
Level of physical activity
- The three-question (3Q) physical activity (PA) assessment tools will be used to measure physical activity.
Timepoint [9] 437986 0
Baseline and at 6- and 12-months follow-ups.
Secondary outcome [10] 437987 0
Fruit and vegetable intake
- Patients will be asked about their fruit and vegetable intake in the patient survey. These items has been previously used in the New South Wales Health Survey [1].

1. Centre for Epidemiology and Research. 2010 Report on Adult Health from the
New South Wales Population Health Survey. Sydney: NSW Department of Health, 2011.
Timepoint [10] 437987 0
Baseline and at 6- and 12-months follow-ups.

Eligibility
Key inclusion criteria
(i) active patients (i.e. visited the practice at least three times within the last two years)
(ii) diagnosed with type 2 diabetes
(iii) those with poorly controlled diabetes (i.e., most recent HbA1c > 7.5%);
(iv) aged 18-75 years; (v) able to access the online application via an iOS or Android smart device.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

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)
Allocation will be concealed. A statistician will perform randomisation using de-identified practice IDs via computer generated allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Group allocation will be created with blocks of sizes six selected randomly.
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
The analysis will follow intention to treat principles, where patients will be analysed according to the practice they were attending at randomisation, and missing data will be imputed using multiple imputation methods. The intention to treat population will include all patients with a type 2 diabetes diagnosis who were active patients in the baseline or follow-up period. Baseline characteristics will be summarised between the groups using means and standard deviations for continuous variables and frequencies/counts for categorical variables. The primary outcome variable (mean % HbA1c level) will be measured at 6- and 12-months post-randomisation. The difference between intervention arms will be assessed using linear mixed effects regression models. Regression models will incorporate random effects for practices, GPs nested within practices, patients nested within GPs (for repeated measures on the same patient), as well as fixed effects for the practice level mean baseline value of the outcome and treatment group and stratification variables. The same model will be used to assess differences in the continuous secondary outcome variables (i.e., macro-vascular risk and quality of life). A transformation will be applied if the distributional assumptions are not met.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/08/2024
Actual
23/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
375
Accrual to date
9
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 312836 0
Government body
Name [1] 312836 0
National Health and Medical Research Council, Medical Research Future Fund (MRFF)
Country [1] 312836 0
Australia
Primary sponsor type
University
Name
Bond University
Address
14 University Drive (off Cottesloe Drive) Robina QLD 4226, Australia
Country
Australia
Secondary sponsor category [1] 314491 0
University
Name [1] 314491 0
The University of Newcastle
Address [1] 314491 0
University Dr, Callaghan NSW 2308
Country [1] 314491 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312114 0
Bond University Human Ethics Committee
Ethics committee address [1] 312114 0
14 University Drive (off Cottesloe Drive) Robina QLD 4226, Australia
Ethics committee country [1] 312114 0
Australia
Date submitted for ethics approval [1] 312114 0
11/11/2022
Approval date [1] 312114 0
03/01/2023
Ethics approval number [1] 312114 0
BH00137
Ethics committee name [2] 312123 0
University of Newcastle Human Ethics Committee
Ethics committee address [2] 312123 0
University Dr, Callaghan NSW 2308
Ethics committee country [2] 312123 0
Australia
Date submitted for ethics approval [2] 312123 0
24/01/2023
Approval date [2] 312123 0
24/01/2023
Ethics approval number [2] 312123 0
H-2023-0027

Summary
Brief summary
The prevalence of diabetes is increasing in Australia. Lifestyle behaviours and patient self-management are crucial for improving diabetes control but are difficult to achieve in primary care. While an integrated digital care may be effective, there is limited research. Primary aim: The study will examine the effectiveness and cost-effectiveness of the multi-component Wear-IT intervention in achieving clinically significant reductions in HbA1c among general practice patients.

A cluster randomised controlled design will be used with general practice clinics randomly assigned to either intervention (n=15) or usual care (n=15). Twenty patients will be recruited from each clinic. Patients will be eligible to participate if they were aged 18-75 years; had poorly controlled diabetes (i.e., most recent HbA1c greater than 7.5%); and were able to access the online application via an iOS or Android smart device. Those attending the usual care practices will receive standard care. A new model of care consisting of patient self-management digital support (i.e., wearable device, education, and glucose monitoring) approach and clinician management digital support (delivered by the practice nurse with review and endorsement of goals by the patient's GP) will be provided to the intervention group.

Outcomes at baseline, 6- and-12-months follow- up include HbA1c (primary outcome), macro vascular risk (LDL-C less than 2.0mmol/L and a blood pressure reading of =140/90 mmHg), quality of life (36-item short form version 2)) and cost-effectiveness (quality-adjusted life years derived from SF-36). Healthcare utilization will be examined via PenCS medical report. Participants will complete a survey at 6- and 12-months, including sociodemographic characteristics, health risk behaviours, patient knowledge, skill and confidence for diabetes self-management (process measures). Intervention participants will also complete a 6-and-12 month survey about the ease of use, relevance, and quality of the intervention (feasibility and acceptability). GP and practice nurses views about their experience with utilising and delivering the intervention will be assessed by a brief survey and qualitative interviews. The primary analysis population will be the intention to treat, defined as all randomised participants. The secondary outcome variables will be compared between treatment arms using separate linear mixed effects regression models. Inductive thematic analysis will be used to analysis qualitative data.

This study has the potential to improve self-management of diabetes among those with poorly controlled type 2 diabetes. This novel integrated process will empower patients with self-care knowledge and management of diabetes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123526 0
Prof Nicholas Zwar
Address 123526 0
Bond University, 14 University Drive (off Cottesloe Drive) Robina QLD 4226, Australia
Country 123526 0
Australia
Phone 123526 0
+61 7 5595 5499
Fax 123526 0
Email 123526 0
[email protected]
Contact person for public queries
Name 123527 0
Breanne Hobden
Address 123527 0
University of Newcastle, W4, HMRI Building, University Drive Callaghan, NSW 2308
Country 123527 0
Australia
Phone 123527 0
+61 431310511
Fax 123527 0
Email 123527 0
[email protected]
Contact person for scientific queries
Name 123528 0
Breanne Hobden
Address 123528 0
University of Newcastle, W4, HMRI Building, University Drive Callaghan, NSW 2308
Country 123528 0
Australia
Phone 123528 0
+61 431310511
Fax 123528 0
Email 123528 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?
Data from this study are not publicly available because of ethical restrictions on data sharing to protect patient confidentiality. Under the terms of our approval, it is required that access to data is restricted to study personnel. Deidentified data and the statistical code for generating the results will be made available on request to the request to the research team, pending ethical approval.
When will data be available (start and end dates)?
Immediately following publication, no end date determined.
Available to whom?
Researchers who provide a sound proposal.
Available for what types of analyses?
IPD meta-analyses.
How or where can data be obtained?
Contact via [email protected]. Additional use of or access to the data requires that the research team submit a request for variation of ethics approval.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23942Study protocol  [email protected]
23943Statistical analysis plan  [email protected]
23944Informed consent form  [email protected]
23945Ethical approval  [email protected]



Results publications and other study-related documents

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