Type 2 Diabetes Mellitus Clinical Trial
Official title:
Type 2 Diabetes: Risk Perceptions and Self-management Behaviour
This pilot randomised controlled trial (RCT) aims to assess the feasibility of using a new
type of risk communication intervention for people with Type 2 diabetes mellitus (T2DM) in
primary care and to evaluate its potential impact on risk perceptions and self-management
behaviour.
The study comprises 40 participants with T2DM randomly allocated to usual care supported by
the risk communication intervention or usual care only.
Diabetes self-management, which includes self-care behaviours such as healthy eating and
physical exercise, has become the cornerstone for treating type-2 diabetes mellitus (T2DM).
However, although self-management education (SME) is necessary to equip patients with the
knowledge, skills and attitudes required to manage their diabetes care, the most effective
method to do so is still unclear.
Recent studies have shown that people with T2DM underestimated their risks of developing
complications. Although behavioural processes are complex, wrong risk perceptions are a major
impediment to the adoption of self-care behaviours and, as a result, an additional risk for
the occurrence of adverse outcomes.
Existing risk communication interventions have shown mixed results, with many participants
barely understanding the explanations of health professionals about risks and having poor
recall of risk information. In this context, there is a need for better risk communication
interventions.
Based on the results of recent studies investigating the risk perceptions and risk attitudes
of people with T2DM, we have developed a new, tailored risk communication intervention. The
objectives of this intervention are:
- To increase the awareness of risks for complications associated with type 2 diabetes.
- To encourage the adoption of recommended self-care behaviours.
The intervention has been developed in collaboration with both health professionals and
patients. We have designed a pilot study to assess the feasibility of using the intervention
in primary care and to evaluate its potential impact on patients' risk perceptions and
self-management behaviour, in order to inform the design of a largest study (RCT to be
conducted in the future)
The intervention lasts 5 minutes on average, conducted by the general practitioner (GP)
during patients' routine primary care consultation. The study involves 40 participants with
T2DM randomly allocated to usual care supported by the risk communication intervention or
usual care only.
The research is supported by the National Institute for Health Research (NIHR) Collaboration
for Leadership in Applied Health Research and Care Oxford at Oxford Health NHS Foundation
Trust.
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