Development and preliminary evaluation of a psychosocial intervention for modifying psychosocial risk factors associated with foot re-ulceration in diabetes.

Diabetic foot ulcers are a common, chronic and costly complication of Diabetes, with the greatest risk for ulceration being previous ulceration. Previous approaches to reducing re-ulceration risk have not, however, considered the psychosocial factors which may influence this risk. We reviewed the existing evidence in this area and developed a therapeutic model which informed the content, structure and format of a psychosocial intervention designed to modify the psychosocial risk factors associated with re-ulceration. The intervention was subjected to a qualitative evaluation in a feasibility study which involved a randomised controlled trial in which 10 individuals were randomised to receive the intervention and 5 individuals to usual care. Individuals in both arms participated in in-depth qualitative interviews after the first 10 weeks of the intervention and again after the final maintenance session. The intervention was perceived as acceptable and patients' reported evidence of sustained change in several of the psychosocial risks identified in the therapeutic model. These observations were supported in the descriptive findings obtained from questionnaires measuring mood, cognitions, behaviour and social support. The intervention appears to offer an acceptable and effective way of modifying the psychosocial risk factors associated with re-ulceration.

RCT Entities:   Population Interventions Outcomes