Type 2 Diabetes: Risk Perceptions and Self-management Behaviour

NCT03840850 | Completed

• 1 other identifier: 17/NW/0267
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Recall of personalised risk information

  3 months

• Intentions to make lifestyle changes

  3 months

• Change in self-management behaviour

  3 months

Other Outcomes (6)

• Consent rate

  3 months

• Acceptability of the intervention

  Immediately after the intervention

• Anxiety due to the intervention

  Immediately after the inervention

Study Arms (2)

Intervention and usual care

EXPERIMENTAL

Risk communication intervention and usual care including personalized lifestyle advice

Other: Personalized Risk Communication for People with Type 2 Diabetes

Usual care only

NO INTERVENTION

Usual care including personalized lifestyle advice

Interventions

Personalized Risk Communication for People with Type 2 Diabetes 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.

Intervention and usual care

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

27 Beaumont Street Surgery Practice

Oxford, Oxfordshire, OX1 2NR, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: February 15, 2019
• Study Start: September 15, 2017
• Primary Completion: February 9, 2018
• Study Completion: February 9, 2018
• Last Updated: February 15, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)