The efficacy and feasibility of the use of motivational interviewing to improve adherence to wearing prescribed footwear in diabetic foot patients

Foot ulceration is a severe complication of diabetes that is an important
precursor to infection and amputation. Therefore, prevention of ulceration is
of paramount importance in this patient group. Treatment often includes the use
of prescribed orthopaedic footwear. To be effective in prevention, prescribed
footwear should be worn by the patient, in particular when being ambulant.
However, adherence to wearing prescription footwear is known to be low in
diabetic patients with foot complications. Furthermore, ulcer recurrence is
prevalent in this patient group. Therefore, ways should be found to improve
adherence in order to improve clinical outcome. Motivational interviewing has
been shown to be an effective evidence-based patient education method to change
behaviour of patients, including those with diabetes. The technique is a
directive, client-centred counselling style for eliciting behavioural change by
helping clients to explore and resolve ambivalence. We hypothesize that
motivational interviewing is also effective in changing behaviour of diabetic
foot patients to wear prescribed footwear since these patients are generally
reluctant to change or are ambivalent about changing their behaviour, two
domains where motivational interviewing is being considered as particularly
useful.

The primary objective of this study is to assess the efficacy of the use of
motivational interviewing to improve adherence to wearing prescribed footwear
in diabetic foot patients. Secondary objectives are to assess the feasibility
of applying motivational interviewing to improve adherence in patients with a
diabetic foot, to assess normal variability in adherence over time, to explore
causes of non-adherence in wearing prescribed footwear in diabetic patients,
and to assess in-shoe plantar pressures in the footwear that patients wear
while they are at home.

A pilot RCT and an observational study of a cohort

The control group receives usual care, while the intervention group
additionally receives 2 sessions of motivational interviewing.

The risks associated with this study are negligible. A small sensor is placed
in the patients* shoe, and a step activity monitor is worn around the ankle,
both causing no adverse events in the many measurements that we have performed
to date. Both will be worn for 7 consecutive days. Depending on the study
group, patients require 3 to 6 extra visits to the outpatient clinic. A benefit
may be that adherence increases as a result of the intervention. Previous
research from our group has shown that if adherence can be assured in
combination with adequate pressure relief in the shoe, risk for ulceration can
be substantially reduced.