Type 2 Diabetes: Risk Perceptions and Self-management Behaviour

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Other: Personalized Risk Communication for People with Type 2 Diabetes

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX1 2NR
      • 27 Beaumont Street Surgery Practice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention and usual care; Risk communication intervention and usual care including personalized lifestyle advice	Other: 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.
No Intervention: Usual care only; Usual care including personalized lifestyle advice

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recall of personalised risk information	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.	3 months
Intentions to make lifestyle changes	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.	3 months
Change in self-management behaviour	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.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consent rate	Rate of eligible subjects consenting to participate in the study (%)	3 months
Acceptability of the intervention	Participants' acceptability of the intervention is measured using adapted questions from the COMRADE (Combined Outcome Measure for Risk communication And treatment Decision-making Effectiveness) scale, which was validated for use in the UK. This scale consists of 10 questions on a 5-point scale ranging from 0 (strongly disagree) to 5 (strongly agree) and is used immediately after the intervention. The scores of each question are combined to compute an average score. Higher average scores represent a better outcome.	Immediately after the intervention
Anxiety due to the intervention	Following Welschen et al. (2012), a question adapted from Claassen et al. (2010) is used to assess how anxious participants are about their personalised risk information (7-point Likert scale ranging from 0 (not anxious at all) to 7 (very much anxious). Higher scores represent a worse outcome.	Immediately after the inervention
Worry due to the intervention	Following Welschen et al. (2012), a question adapted from Claassen et al. (2010) is used to assess how worried participants are about their personalised risk information (7-point Likert scale ranging from 0 (not worried at all) to 7 (very much worried). Higher scores represent a worse outcome.	Immediately after the intervention
Retention rate	Rate of participants who stay enrolled in the study until it ends (%)	3 months
Rate of missing data	Rate of missing data in participants' self-reported questionnaires (%)	3 months

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: NIHR Collaboration for Leadership in Applied Health Research and Care (Oxford)

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2017
• Primary Completion (Actual): February 9, 2018
• Study Completion (Actual): February 9, 2018

Study Registration Dates

• First Submitted: January 18, 2019
• First Submitted That Met QC Criteria: February 12, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 12, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Type 2 diabetes mellitus
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 17/NW/0267

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No