The Diabetes Manual trial protocol - a cluster randomized controlled trial of a self-management intervention for type 2 diabetes [ISRCTN06315411].

ABSTRACT:

Background

The Diabetes Manual is a type 2 diabetes self-management programme based upon the clinically effective 'Heart Manual'. The 12 week programme is a complex intervention theoretically underpinned by self-efficacy theory. It is a one to one intervention meeting United Kingdom requirements for structured diabetes-education and is delivered within routine primary care.

Methods/design

In a two-group cluster randomized controlled trial, GP practices are allocated by computer minimisation to an intervention group or a six-month deferred intervention group. We aim to recruit 250 participants from 50 practices across central England. Eligibility criteria are adults able to undertake the programme with type 2 diabetes, not taking insulin, with HbA1c over 8% (first 12 months)

SUBMITTER: Sturt J 

PROVIDER: S-EPMC1555586 | biostudies-literature | 2006 Jul

REPOSITORIES: biostudies-literature