Self-care and misplaced confidence: a randomised controlled trial of provision of VibraTip for patients with diabetes at high risk of complications

The aims of this study were to assess the feasibility of a randomised controlled trial of foot care using patients recruited from the retinal imaging clinic, and to determine whether in addition to standard care and advice, giving patients with diabetes a VibraTip would enhance confidence in foot self-care.
Sixty subjects recruited in retinal imaging clinics were randomised to receive a standard foot care leaflet, or leaflet plus VibraTip with a demonstration of its use. VibraTip recipients were encouraged to take it home but given no further instructions. Participants were asked to complete a ‘confidence in self-care’ questionnaire at enrolment and follow up, six months later. Recruitment was completed in three, all-day clinics. Follow-up rates were also high with only one subject lost from each group. Confidence in the ability to check feet for sores or blisters rose in the control group from 90.4% to 96.6% and fell from 90% to 88.6% in the VibraTip group.
The feasibility results indicate that large randomised controlled trials in this patient group would be achievable for short educational interventions. Although only a feasibility trial, the study suggested that, if anything, providing VibraTip might actually cast doubt in the minds of patients with diabetes who had been very confident that they could look after their feet. Self-confidence may be more likely to foster complacency than behaviours likely to minimise risk of harm.