Motivational Interviewing for The Prevention of Diabetes-Related Foot Ulceration in People Exposed to Multiple Deprivation: A Pilot Trial

Study team

Lead Investigator: Dr Ruth Barn

Associate Investigators: Dr Gordon Hendry (Co-Lead Investigator & Trials Expert); Dr Jodi Binning (MI Expert and Podiatrist); Dr Nicola Irvine (Health Economist); Prof Brian Kennon (Diabetologist); Prof Graham Leese (Diabetologist); Prof Helen Mason (Health Economist); Prof Alex McConnachie (Senior Statistician); Kaye McIntyre (Diabetes Podiatrist); Bethany Stanley (Statistician)

Trial Project Manager: Diann Taggart

Research Associate: Mehrad Tafreshi

Funder: Scottish Government’s Chief Scientist Office (CSO)

Webpage: www.miditrial.com

Background

Diabetes-related foot ulceration (DFU) is a serious complication associated with high morbidity, mortality, and healthcare costs. Despite existing guidelines, recurrence rates remain high, particularly among individuals exposed to social deprivation, which has been linked to increased risk of amputation and death. Traditional patient education has shown limited effectiveness in preventing DFU, as behaviour change is influenced by complex personal, social, and environmental factors. Motivational Interviewing (MI) is a personalised approach that has demonstrated success in enhancing adherence and behaviour change across various health contexts. Our feasibility study on MI for DFU prevention showed promising results, indicating acceptability and effective delivery by podiatrists. This pilot trial will further refine and evaluate our MI intervention, specifically for individuals exposed to multiple deprivations, determining its feasibility for a larger trial in line with Scottish Government healthcare priorities.

Aims

To pilot test the proposed trial components and address uncertainties associated with conducting a future full-scale, definitive, randomised, controlled trial of motivational interviewing to prevent diabetes-related foot ulceration in people exposed to multiple deprivations.

Objectives

This study aims to evaluate the feasibility of recruiting and retaining participants, including their willingness to be randomised. It will also assess the acceptability of the intervention and whether it can be delivered as intended. A key consideration is determining whether ulcer event rate is a viable primary outcome measure for future research. Additionally, the study seeks to identify barriers to participation and explore whether data on resource use and costs can be effectively collected for economic evaluation.

Study design

Scotland-wide, multi-centre, pilot 2-arm randomised controlled trial with embedded economic evaluation and qualitative study.