Type 2 Diabetes: Risk Perceptions and Self-management Behaviour

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Other: Personalized Risk Communication for People with Type 2 Diabetes

• Registration Number: NCT03840850
• Lead Sponsor: University of Oxford

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 Timeline

• Study Start: 2017-09-15
• Primary Completion: 2018-02-09
• Study Completion: 2018-02-09
• Status Verified: 2019-01
• Study First Submitted: 2019-01-18
• Study First Submitted QC: 2019-02-12
• Last Update Submitted: 2019-02-12
• Study First Posted: 2019-02-15
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Participant is willing and able to give informed consent for participation in the study.
• Diagnosed with type-2 diabetes.

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Exclusion Criteria

• Unable to provide informed consent.
• Non-English speaker.
• Not suitable for the study according to GP.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention and usual care	Personalized Risk Communication for People with Type 2 Diabetes	Risk communication intervention and usual care including personalized lifestyle advice

Primary Outcome Measures

Name	Time	Method
Feasibility of implementing the intervention in primary care: Binary outcome (feasible / not feasible), as judged by the investigators	3 months	Binary outcome (feasible / not feasible), as judged by the investigators following analysis of study pre-specified outcome measures.

Secondary Outcome Measures

Name	Time	Method
Recall of personalised risk information	3 months	Recall of personalised risk information is measured immediately and 3 months after the intervention.; Type of question used: "The doctor has recently calculated your personalised risk information on his computer. Do you remember these numbers?; Binary outcome: information recalled or information not recalled. Recall of information represents a better outcome. Rates of information recall (%) are compared between the two groups.
Intentions to make lifestyle changes	3 months	Intentions to make lifestyle changes are measured immediately before and after the intervention using the validated Determinants of Lifestyle Behaviour Questionnaire (DLBQ). The DLBQ consists of three parts: intentions to eat healthier, to increase physical activity, and to reduce smoking consumption. Intentions are assessed by a 5-point Likert scale ranging from 0 (strongly disagree) to 5 (strongly agree). Each dimension score is assessed individually. Higher scores represent a better outcome.
Change in self-management behaviour	3 months	Change in self-management behaviour from baseline to 3 months is measured using the validated Summary of Diabetes Self-Care Activities (SDSCA) questionnaire. This instrument explores six dimensions of self-management (healthy eating, physical activity, medication adherence, self-monitoring of blood glucose, foot checks and smoking behaviour), using the self-reported frequency of completing recommended activities during the past seven days as an outcome (SDSCA score ranging from 0 to 7 for each dimension). Each dimension score is assessed individually. Higher scores represent a better outcome.

Trial Locations

Locations (1)

27 Beaumont Street Surgery Practice; 🇬🇧 Oxford, Oxfordshire, United Kingdom