Type 2 Diabetes: Risk Perceptions and Self-management Behaviour
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Personalized Risk Communication for People with Type 2 Diabetes
Intervention type(s): Other
Intervention description(s): The risk communication intervention consists of communicating the impact of being poorly controlled on two types of outcome: (1) absolute 10-year risk of experiencing a cardiovascular event, i.e. heart attack or stroke (10-year CV risk); (2) life expectancy. These personalized risk estimates are calculated based on the UKPDS outcomes model (version 2), which is a prognostic model of reference in the area of Type 2 diabetes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Type 2 diabetes mellitus