Clinical trial NCT03840850: Type 2 Diabetes: Risk Perceptions and Self-management Behaviour
Official title: Type 2 Diabetes: Risk Perceptions and Self-management Behaviour
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: NIHR Collaboration for Leadership in Applied Health Research and Care (Oxford)
First posted: 2019-02-15
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Feasibility of implementing the intervention in primary care: Binary outcome (feasible / not feasible), as judged by the investigators
timeFrame: 3 months
Secondary outcomes:
measure: Recall of personalised risk information
timeFrame: 3 months
measure: Intentions to make lifestyle changes
timeFrame: 3 months
measure: Change in self-management behaviour
timeFrame: 3 months
Other outcomes:
measure: Consent rate
timeFrame: 3 months
measure: Acceptability of the intervention
timeFrame: Immediately after the intervention
measure: Anxiety due to the intervention
timeFrame: Immediately after the inervention
measure: Worry due to the intervention
timeFrame: Immediately after the intervention
measure: Retention rate
timeFrame: 3 months
measure: Rate of missing data
timeFrame: 3 months
Locations:
city: Oxford
country: United Kingdom
facility: 27 Beaumont Street Surgery Practice
state: Oxfordshire
Study officials:
References: