Open Access Highly Accessed Study protocol

The INSPIRED study: a randomised controlled trial of the Whole Person Model of disease self-management for people with type 2 diabetes

David M Clarke1*, Donita E Baird1, Dinali N Perera1, Virginia L Hagger2 and Helena J Teede3

Author Affiliations

1 Department of Psychological Medicine, Monash University and Monash Health, Level 3, P Block, Monash Medical Centre, 246 Clayton Rd, Clayton, 3168 Melbourne, VIC, Australia

2 Diabetes Australia Victoria, Melbourne, Australia

3 Monash Centre for Health Research and Implementation, School of Public Health and Preventative Medicine, Monash University and Diabetes Unit, Monash Health, Melbourne, Australia

For all author emails, please log on.

BMC Public Health 2014, 14:134  doi:10.1186/1471-2458-14-134

Published: 8 February 2014

Abstract

Background

The prevalence of type 2 diabetes has increased dramatically in the last decade, and is continuing to rise. It is a chronic condition, often related to obesity, diet and sedentary lifestyles, and can lead to significant health complications, disability and early death. Diabetes is commonly associated with depression, which can impact significantly on a person’s ability to manage their illness and, consequently, on disease outcomes. Disease self-management is fundamental in diabetes and requires support from multiple health professionals and the active participation of the person, including in maintaining a healthy lifestyle. The Whole Person Model was developed in order to integrate emotional and behavioural aspects into a self-management program for people with type 2 diabetes. Here we describe a study designed to test the efficacy of the Whole Person Model of disease self-management in type 2 diabetes.

Methods/Design

In a parallel-group randomised trial, 180 people with type 2 diabetes of between 2–10 years duration will be recruited via invitation through the Australian National Diabetes Services Scheme. Participants will undergo baseline assessment, followed by randomisation to either intervention or control condition. Control participants will receive fact sheets containing key information about diabetes self-management. The intervention group will receive the INSPIRED (Individual Support & Resources for Diabetes) Manual and be assigned a Health Coach. The INSPIRED Manual consists of six modules that provide key information about diabetes and disease management using the Whole Person Model. Engagement is facilitated by interactive tasks and contact with a Health Coach over seven weeks – an introductory face-to-face session, and six subsequent contacts by phone following each module. Follow-up assessments occur at 13 weeks (post-intervention) and 26 weeks. Primary outcomes include blood glucose management (HbA1c), weight and mood. Secondary outcomes include level of exercise, confidence to manage diabetes, and psychosocial well-being.

Discussion

The Whole Person Model is designed to enable health professionals to address mood disturbance without pathologizing any disorders and, in the context of the chronic illness, empowering behavior change and self-management. If proven effective, this model will strengthen capacity of the healthcare workforce to foster and support effective diabetes self-management.

Trial registration

Australia and New Zealand Clinical Trials Register, ACTRN12613000391774

Keywords:
Type 2 diabetes mellitus; Diabetes; Self-management; Depression; Support; Resources