The Management to Optimise Diabetes and mEtabolic syndrome Risk reduction via Nurse-led intervention (MODERN) Study

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Diabetes; Cardiovascular disease (CVD) risk factors; Health disparities in regional communities; Public Health - Health service research; Metabolic and Endocrine - Metabolic disorders; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12616000229471
• Lead Sponsor: Mary MacKillop Institute for Health Research, Australian Catholic University

Brief 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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-19
• Study Completion: 2018-02-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 276

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.

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

• Study Type: Interventional
• Study Design: Not specified