Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT03840850
Brief 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.
Study:
NCT03840850
Study Brief:
Protocol Section:
NCT03840850