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Clinical Trials/NCT03840850
NCT03840850
Completed
Not Applicable

Type 2 Diabetes: Risk Perceptions and Self-management Behaviour

University of Oxford1 site in 1 country40 target enrollmentSeptember 15, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 2 Diabetes Mellitus
Sponsor
University of Oxford
Enrollment
40
Locations
1
Primary Endpoint
Feasibility of implementing the intervention in primary care: Binary outcome (feasible / not feasible), as judged by the investigators
Status
Completed
Last Updated
7 years ago

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. 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.

Registry
clinicaltrials.gov
Start Date
September 15, 2017
End Date
February 9, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

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)

Study Sites (1)

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