Type 2 Diabetes: Risk Perceptions and Self-management Behaviour

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Type 2 Diabetes: Risk Perceptions and Self-management Behaviour

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03840850
• Other study ID #: 17/NW/0267
• Status: Completed
• Phase: N/A
• Start date: September 15, 2017
• Est. completion date: February 9, 2018

Study information

• Verified date: January 2019
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 9, 2018
• Est. primary completion date: February 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	27 Beaumont Street Surgery Practice	Oxford	Oxfordshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	NIHR Collaboration for Leadership in Applied Health Research and Care (Oxford)

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Consent rate	Rate of eligible subjects consenting to participate in the study (%)	3 months
Other	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
Other	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
Other	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
Other	Retention rate	Rate of participants who stay enrolled in the study until it ends (%)	3 months
Other	Rate of missing data	Rate of missing data in participants' self-reported questionnaires (%)	3 months
Primary	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	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
Secondary	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
Secondary	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