Type 2 Diabetes: Risk Perceptions and Self-management Behaviour

NCT ID: NCT03840850

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-15
• Study Completion Date: 2018-02-09

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Intervention and usual care

Risk communication intervention and usual care including personalized lifestyle advice

Group Type: EXPERIMENTAL

Personalized Risk Communication for People with Type 2 Diabetes

Intervention Type: OTHER

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.

Usual care only

Usual care including personalized lifestyle advice

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Personalized Risk Communication for People with Type 2 Diabetes

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NIHR Collaboration for Leadership in Applied Health Research and Care (Oxford)

UNKNOWN

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

27 Beaumont Street Surgery Practice

Oxford, Oxfordshire, United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

17/NW/0267

Identifier Type: -

Identifier Source: org_study_id