Type 2 Diabetes: Risk Perceptions and Self-management Behaviour
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Oxford
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Feasibility of implementing the intervention in primary care: Binary outcome (feasible / not feasible), as judged by the investigators
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 30 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participant is willing and able to give informed consent for participation in the study.
- •Diagnosed with type-2 diabetes.
Exclusion Criteria
- •Unable to provide informed consent.
- •Non-English speaker.
- •Not suitable for the study according to GP.
Arms & Interventions
Intervention and usual care
Risk communication intervention and usual care including personalized lifestyle advice
Intervention: Personalized Risk Communication for People with Type 2 Diabetes (Other)
Usual care only
Usual care including personalized lifestyle advice
Outcomes
Primary Outcomes
Feasibility of implementing the intervention in primary care: Binary outcome (feasible / not feasible), as judged by the investigators
Time Frame: 3 months
Binary outcome (feasible / not feasible), as judged by the investigators following analysis of study pre-specified outcome measures.
Secondary Outcomes
- Recall of personalised risk information(3 months)
- Intentions to make lifestyle changes(3 months)
- Change in self-management behaviour(3 months)