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Trial registered on ANZCTR


Registration number
ACTRN12616000229471
Ethics application status
Approved
Date submitted
11/02/2016
Date registered
19/02/2016
Date last updated
19/06/2019
Date data sharing statement initially provided
6/02/2019
Date results information initially provided
6/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Management to Optimise Diabetes and mEtabolic syndrome Risk reduction via Nurse-led intervention (MODERN) Study
Scientific title
The Management to Optimise Diabetes and mEtabolic syndrome Risk reduction via Nurse-led intervention (MODERN) Study
Secondary ID [1] 288522 0
National Health and Medical Research Council (NHMRC) Project Grant 1069043
Universal Trial Number (UTN)
Trial acronym
The MODERN Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Syndrome 297604 0
Diabetes 297605 0
Cardiovascular disease (CVD) risk factors 297606 0
Health disparities in regional communities 297607 0
Condition category
Condition code
Public Health 297797 297797 0 0
Health service research
Metabolic and Endocrine 297798 297798 0 0
Metabolic disorders
Metabolic and Endocrine 297799 297799 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A total of 300 individuals with clinically diagnosed metabolic syndrome (MetS) and/or type 2 diabetes mellitus (T2DM) will be randomised to Usual Care (UC, n=150) or the MODERN intervention (n=150). During the 24-month management program:
1. UC participants will visit the clinic and undergo non-invasive clinical assessments, finger prick blood samples to monitor their MetS risk factors and progression, complete research questionnaires about health behaviours’ and overall health status on 3 occasions (baseline, 12 and 24 months) that take approximately 60 minutes.
2. MODERN intervention participants will have between 1 and 4 extra clinic visits lasting approximately 60 minutes each over 24 months (in addition to the baseline, 12 and 24 months clinic visits). The exact number of visits will depend on the amount of assistance required to manage an individual’s level of risk based on the adaptation of the intensity of management according to risk and need using the GARDIAN (Green Amber Red Delineation of rIsk And Need) system. The GARDIAN system [*] is a traffic-light system developed to systematically categorise individual risk and need. Based on the initial comprehensive baseline profiling, each participant in the MODERN intervention group will be designated a traffic light colour RED (high), AMBER (intermediate) or GREEN (low), to describe the level of care provided by one of three management levels (+ additional visits): Green: 18 month contact; Amber: 6 and 18 month clinic visits; Red: 3, 6, 15 and 18 month clinic visits. These visits include non-invasive clinical assessments and finger prick blood samples to monitor their MetS risk factors and progression.
The research nurse will provide an individual care plan according to identified risk factors (with input from nurse diabetes educators, the participant and their family/carers, and any other health care team members) and provide education and advice in order to minimise risk based on the 5As model. The 5As model consists of behavioural counselling to help individuals to change multiple health behaviours. The objective is to help participants to develop a personal action plan by systematically applying a series of five interrelated behaviour change principles. An outline of the sequence of support activities is as follows:
Step 1 ASSESS
i. biomedical, behavioural, socio-demographic and familial risk factor results in contrast to recommended levels from published guidelines and reports.
ii. self-efficacy – beliefs (importance, confidence, intentions) in the participants ability to succeed in a particular situation (i.e. in their ability to complete tasks, change behaviours and reach goals).
Step 2 ADVISE:
i. health risks of the many risk factors linked to CVD and diabetes.
ii. benefits of changing one or more behaviours.
iii. recommend (based on published guidelines and reports) the appropriate amount, intensity and frequency of behaviour needed to help reduce the risk for CVD and diabetes.
Step 3 AGREE:
i. list and collaboratively set specific goals (in behavioural terms) based on the participant’s interest and confidence to perform the behaviour, which are mutually negotiated and achievable.
ii. develop an agreed personal action plan (what, when, where, how).
Step 4 ASSIST:
i. list any real or anticipated personal barriers to achieving the identified goals and document strategies to overcome these barriers.
ii. identify and aid in connecting with potential community programs or opportunities for lifestyle improvement and social support.
iii. provide educational brochures to be used as a resource and reminder for behaviour change.
Step 5 ARRANGE:
i. specify a plan for follow-up visits, telephone calls, email reminders according to the GARDIAN system (see above).
ii. recommend referral to a medical or allied health professional (e.g. dietician), including utilisation of video conferencing (Tele Health) for treatment or improved pharmacological management.
iii. make use of self-monitoring and completion of a health passport to record behavioural and lifestyle changes for tracking progress and providing feedback.

The clinic manager will be responsible for scheduling all clinic appointments based on a centralised database/calendar. All MODERN intervention participants will also be provided with a ‘MODERN Study Health Passport” with all scheduled appointments and all clinical results. This booklet also contains relevant health information and a comprehensive list of latest evidence-based guidelines and recommendations on metabolic syndrome and CVD risk factors.

*Carrington MJ, Kok S, Jansen K, Stewart S. The Green, Amber, Red Delineation of Risk and Need (GARDIAN) management system: a pragmatic approach to optimizing heart health from primary prevention to chronic disease management. Eur J Cardiovasc Nurs 2013; 12(4):337-345.
Intervention code [1] 293886 0
Prevention
Intervention code [2] 293887 0
Lifestyle
Intervention code [3] 293888 0
Behaviour
Comparator / control treatment
Usual care
Control group
Active

Outcomes
Primary outcome [1] 297322 0
Achievement of 3 or more targets (based on the clinical diagnosis of MetS) or clinically meaningful changes in contributory risk factors. Blood pressure (BP) Target: systolic BP less than or equal to 130 mmHg and/or diastolic BP less than or equal to 85 mmHg. Clinical change: to reduce BP by more than or equal to 7/3 mmHg (in men) and more than or equal to 8/4 mmHg (in women). Triglyceride Target: less than or equal to 1.7 mmol/L. Clinical change: to reduce triglyceride levels by more than or equal to 0.6 mmol/L (in men) and more than or equal to 0.5 mmol/L (in women). HDL-C Target: more than 1.03 mmol/L (in men) and more than 1.29 mmol/L (in women) Clinical change: to increase HDL-C by more than or equal to 0.15 mmol/L (in men) and more than or equal to 0.18 mmol/L (in women). Waist circumference Target: less than 94 cm (in men) and less than 80 cm (in women). Clinical change: to reduce waist circumference by more than or equal to 5 cm (in men) and more than or equal to 6 cm (in women). Glucose Target: HbA1c less than or equal to 5.6%. Clinical change: to reduce HbA1c by more than or equal to 0.4% (in men) or more than or equal to 0.5% (in women).
Timepoint [1] 297322 0
At study completion (24 months after randomisation).
Secondary outcome [1] 320728 0
Biomedical risk – any changes indicative of improvement in risk profile including individual MetS risk factors; absolute CVD risk [1]; adiposity (body mass index: kg/m^2 and body weight); lipids (total cholesterol, LDL-cholesterol: point of care device and blood pathology testing); renal function (estimated glomerular filtration rate [eGFR]); vascular health (ankle brachial index and arterial stiffness [2]); biomarkers of CVD risk (high sensitive C-reactive protein: blood pathology testing [3]) and pharmacological treatments (face to face interview).

1National Vascular Disease Prevention Alliance. Guidelines for the assessment of absolute cardiovascular disease risk: National Heart Foundation of Australia; 2009.
2Shirai K, Hiruta N, Song M, Kurosu T, Suzuki J, Tomaru T, Miyashita Y, Saiki A, Takahashi M, Suzuki K, Takata M. Cardio-ankle vascular index (CAVI) as a novel indicator of arterial stiffness: theory, evidence and perspectives. J Atheroscler Thromb 2011; 18(11):924-938.
3Ridker PM. Clinical application of C-reactive protein for cardiovascular disease detection and prevention. Circulation 2003; 107(3):363-369.

Timepoint [1] 320728 0
At study completion (24 months after randomisation).
Secondary outcome [2] 320729 0
Lifestyle behaviours - any changes indicative of improvement in risk profile including smoking cessation (face to face interview); physical activity and sedentary behavior (IPAQ [1] and actigraphy [2]) and diet (Dietary Questionnaire for Epidemiological Studies Version 2 [DQES v2]) [3].

1Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc 2003; 35(8):1381-1395.
2Trost SG, McIver KL, Pate RR. Conducting accelerometer-based activity assessments in field-based research. Med Sci Sports Exerc 2005; 37(11 Suppl):S531-543.
3Hodge A, Patterson AJ, Brown WJ, Ireland P, Giles G. The Anti Cancer Council of Victoria FFQ: relative validity of nutrient intakes compared with weighed food records in young to middle-aged women in a study of iron supplementation. Aust N Z J Public Health 2000; 24(6):576-583.
Timepoint [2] 320729 0
At study completion (24 months after randomisation).
Secondary outcome [3] 320791 0
Mental health related quality of life - assessed by a validated self-administered questionnaire: AQol-8D [1]

1Richardson J, Elsworth G, Iezzi A, Khan M, Mihalopoulos C, Schweitzer I, Herrman H. Increasing the sensitivity of the AQoL inventory for the evaluation of interventions affecting mental health: Centre for Health Economics, Monash University, Melbourne.; 2011.
Timepoint [3] 320791 0
At study completion (24 months after randomisation)
Secondary outcome [4] 320792 0
Health psychology self-evaluation - assessed by a modified behaviour specific self-efficacy questionnaire designed specifically for this study [1].

1Schwarzer R, Jerusalem M. Generalized Self-Efficacy scale. In: Weinman J, Wright S, Johnston M, eds. Measures in health psychology: A user's portfolio Causal and control beliefs. Windsor, UK: NFER-NELSON; 1995. p. 35-37.
Timepoint [4] 320792 0
At study completion (24 months after randomisation)
Secondary outcome [5] 320793 0
A composite endpoint of participant satisfaction with preferences and willingness-to-pay for overall health care delivery and intervention - assessed by a modified participants' preference questionnaire designed specifically for this study [1].

1Poulton BC. Use of the consultation satisfaction questionnaire to examine patients' satisfaction with general practitioners and community nurses: reliability, replicability and discriminant validity. The British journal of general practice : the journal of the Royal College of General Practitioners 1996; 46(402):26-31.


Timepoint [5] 320793 0
At study completion (24 months after randomisation)
Secondary outcome [6] 320827 0
A composite endpoint of health care system utilisation and cost of community/ specialist care and treatments (including prescription data) via access to Medicare claims data (submission to Medicare).

Timepoint [6] 320827 0
At Study completion (24 months after randomisation)
Secondary outcome [7] 320930 0
Detailed health economic analyses on the cost of applying the MODERN intervention (including staff salaries, consumable and infrastructure costs, referral to other allied-health professionals and services [non-Medicare] and participant out of pocket cost) - assessed by review of study cost records measured during the MODERN program.

Timepoint [7] 320930 0
At study completion (24 months after randomisation)

Eligibility
Key inclusion criteria
1. aged between 40-70 years at the time of recruitment.
2. have a confirmed diagnosis of MetS +/- T2DM.
3. reside in Colac or Shepparton (or surrounding suburbs).
4. be capable of attending clinic visits.
5. be able to provide informed consent.
Minimum age
40 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. any clinically diagnosed form of CVD and/or renal disease.
2. a significant neurological/cognitive impairment or unable to provide written informed consent.
3. any other life-threatening comorbid disease or medical condition that results in the belief (deemed by the CIs) that it is not appropriate for an individual to participate.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible participants will be randomised on a 1:1 basis (150 MODERN intervention:150 UC) following consent and generated via a blinded automated computer program applied by the Data Management Unit. In the unlikely event that two (or more) eligible participants are recruited from the same household, we will ensure that they are randomised to the same study group to reduce intervention contamination.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block (per community) stratified +/- type II diabetes randomisation.
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
N/A
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
We estimate that endpoint data from a minimum of 125 individuals per group will provide 95% study power (assuming a two-sided alpha of 0.05) to detect an absolute 15% difference (20% endpoint achieved in the MODERN intervention group and 5% in the UC group) in the primary endpoint at 24 months. With potential loss to follow-up of 15% (10% in the first year and 5% thereafter) a target of 150 individuals in each group will ensure that sufficient endpoint data will be available to retain estimated study power. Under the same assumptions, this sample size will provide 90% power to detect a 1% absolute difference in absolute cardiovascular risk (from baseline to 24 months) in favour of the MODERN intervention group (conservative mean change 2 +/- 3.8%) compared to the UC group (1 +/- 3.8%).
All analyses will be performed on an intention-to-treat basis. Data from each community will be pooled and summarised with respect to demographic and clinical characteristics. Comparison of baseline and end-point data will involve x^2 analysis (odds ratios and 95% confidence intervals) for discrete variables, Students t-test and Mann-Whitney tests where appropriate. Secondary end-point data analyses will compare change between intervention and usual care subjects using linear regression to correct for between-group differences and obtain the effect size of MODERN relative to other likely determinants of risk factor modification. Multiple logistic regressions will determine independent correlates of achieving the primary endpoint at 24 months.

Recruitment
Recruitment status
Completed
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)
VIC
Recruitment postcode(s) [1] 12749 0
3250 - Colac
Recruitment postcode(s) [2] 12750 0
3630 - Shepparton

Funding & Sponsors
Funding source category [1] 292871 0
Government body
Name [1] 292871 0
NHMRC Project grant
Address [1] 292871 0
GPO Box 1421, Canberra ACT 2601
Country [1] 292871 0
Australia
Primary sponsor type
University
Name
Mary MacKillop Institute for Health Research, Australian Catholic University
Address
Level 5, 215 Spring Street, Melbourne, VIC 3000
Country
Australia
Secondary sponsor category [1] 291615 0
None
Name [1] 291615 0
Address [1] 291615 0
Country [1] 291615 0
Other collaborator category [1] 278814 0
Other Collaborative groups
Name [1] 278814 0
Baker Heart and Diabetes Institute
Address [1] 278814 0
75 Commercial Road, Melbourne, VIC 3004
Country [1] 278814 0
Australia
Other collaborator category [2] 278815 0
University
Name [2] 278815 0
Department of General Practice, Melbourne University
Address [2] 278815 0
200 Berkeley Street, Carlton, VIC 3053
Country [2] 278815 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294373 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 294373 0
The Alfred Hospital, 55 Commercial Rd, Prahran VIC 3181
Ethics committee country [1] 294373 0
Australia
Date submitted for ethics approval [1] 294373 0
01/04/2014
Approval date [1] 294373 0
13/05/2014
Ethics approval number [1] 294373 0
HREC Number: 145/14
Ethics committee name [2] 294374 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [2] 294374 0
Australian Catholic University Melbourne Campus
Locked Bag 4115
FITZROY VIC 3065
Ethics committee country [2] 294374 0
Australia
Date submitted for ethics approval [2] 294374 0
08/08/2014
Approval date [2] 294374 0
09/09/2014
Ethics approval number [2] 294374 0
HREC Number: 2014 244V
Ethics committee name [3] 302580 0
Department of Health Human Research Ethics Committee
Ethics committee address [3] 302580 0
PO Box 7788, Canberra BC, ACT 2610
Ethics committee country [3] 302580 0
Australia
Date submitted for ethics approval [3] 302580 0
27/08/2014
Approval date [3] 302580 0
26/09/2014
Ethics approval number [3] 302580 0
38/2014

Summary
Brief summary
People can have many risk factors, but when a combination group together at the same time, including high blood pressure, obesity, blood glucose (sugar) and lipids (cholesterol and triglyceride), it forms what is called the “metabolic syndrome” and exposes individuals to diabetes and cardiovascular disease. People living in regional areas have higher levels of these risk factors than people living in metropolitan areas. One reason for this is less access to health care. Therefore, a health and lifestyle intervention program led by nurses for participants with metabolic syndrome may be beneficial for preventing these diseases. The aim of this study is to develop a regional health care program that reduces the risk of developing diabetes or cardiovascular disease (such as a heart attack or stroke) by managing risk factors that cause these diseases better.
Trial website
http://www.cre2rihd.org.au/modern.html
Trial related presentations / publications
Nil
Public notes
Attachments [1] 3198 3198 0 0

Contacts
Principal investigator
Name 63478 0
A/Prof Melinda Carrington
Address 63478 0
Baker Heart and Diabetes Institute, 75 Commercial Rd, Melbourne, VIC 3004
Country 63478 0
Australia
Phone 63478 0
+61 3 8532 1638
Fax 63478 0
+61 3 8532 1100
Email 63478 0
melinda.carrington@baker.edu.au
Contact person for public queries
Name 63479 0
A/Prof Melinda Carrington
Address 63479 0
Baker Heart and Diabetes Institute, 75 Commercial Rd, Melbourne, VIC 3004
Country 63479 0
Australia
Phone 63479 0
+61 3 8532 1638
Fax 63479 0
+61 3 8532 1100
Email 63479 0
melinda.carrington@baker.edu.au
Contact person for scientific queries
Name 63480 0
A/Prof Melinda Carrington
Address 63480 0
Baker Heart and Diabetes Institute, 75 Commercial Rd, Melbourne, VIC 3004
Country 63480 0
Australia
Phone 63480 0
+61 3 8532 1638
Fax 63480 0
+61 3 8532 1100
Email 63480 0
melinda.carrington@baker.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
Personal health information about an individual participant will not be shared; only group results will be presented in publications and presentations arising from these data.
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 – plain English summary
A multi-centre trial in regional Victoria was conducted for people aged 40-70 years with MetS and no evidence of CVD or other chronic disease. Presence of 3 or more risk factors including central obesity, low HDL or high triglycerides or high blood pressure (BP) and dysglycaemia were randomized to intervention or control groups. The primary endpoint of achievement of target risk factor thresholds or clinically significant minimum changes for at least 3 MetS risk factors was not met and achieved by 77% of people in the intervention group and 71% of people in the usual care group. MetS was resolved in 57% (intervention) and 48% (controls) of individuals. Change in risk factors were compared and greater improvements were seen in blood pressure, body weight, lipids and blood glucose. Overall cardiovascular risk scores in participants exposed to nurse-led intervention were also significantly lower compared to standard care (-0.9% difference). These findings indicate that an annual heart health check with routine follow up and education is sufficient to achieve risk factor change and revert MetS status. The role of changing medical management is to be assessed but in spite of this, independent community nurse clinics can be effective in reducing the aggregate severity of cardio-metabolic risk factors.