People with both diabetes and visual impairment have high risk for serious, disabling, and potentially deadly foot problems. Foot self-examination is usually taught as a visual procedure, making it inaccessible to persons with visual impairment. The recommendation for usual care from both the American Diabetes Association (ADA) and the International Diabetes Federation (IDF) is that visually impaired people seek sighted assistance for daily foot examination. However, a simple, novel, low-technology intervention, Multiple Senses and Foot Evaluation (Multi-SAFE) uses nonvisual senses (touch and smell) to make foot self-examination accessible to people with visual impairment. This mixed-methods pilot study will compare the efficacy, acceptability, and feasibility of Multi-SAFE with usual care. The study aims are to: (1) compare frequency of foot examination between persons receiving the Multi-SAFE intervention and those receiving usual care, (2) assess the initial efficacy of the Multi-SAFE intervention for detection of new foot problems at home, (3) evaluate the feasibility of the Multi-SAFE intervention compared to usual care in terms of instructional time and classroom resources for teaching the Multi-SAFE intervention, (4) estimate effect size for sample size determination for a future, larger clinical trial, and (5) assess acceptability of Multi-SAFE compared to usual care. The proposed research will enroll 60 persons with diabetes and visual impairment, and use a 2-group randomized clinical trial comparing the Multi-SAFE intervention with usual care. All participants will receive comprehensive diabetes self-management education adapted for persons with visual impairment, including instruction in foot care. The experimental group will receive instruction in the Multi-SAFE intervention. The comparison group will receive usual care instructions for foot examination, which is having a sighted person examine their feet. Participants will be followed for 6 months in a podiatry clinic, with comprehensive podiatry examinations at baseline, at 3 and 6 months, and additional podiatry examinations if a new foot problem is discovered at home. Focus groups will be conducted with each class group after 6 months in the study. Outcome variables include frequency of foot examination at home, the percent of new foot problems developing during the study that were discovered at home, and instructional time and classroom resources. In addition, focus groups held following 6 months in the study will provide information from users about the acceptability of the Multi-SAFE intervention. If evidence supports the efficacy of the Multi-SAFE intervention, the short-term impact could be empowerment of persons with visual impairment to perform regular foot self-examination, resulting in improved detection and treatment of foot problems and substantial decreases in incidence of foot ulcers and amputations. The potential downstream impact is reduced costs of care for diabetes complications on the population level. For every 1% reduction in diabetic foot complications, costs would be reduced by $137 million.
In this pilot study we will compare the effects of teaching two different methods of foot examination to people who have diabetes and visual impairment: Multi-SAFE, a method for nonvisual foot examination that uses the senses of touch and smell, and usual care, which is to have a sighted person look at the feet. We will compare how often people actually examine their feet using each method;whether each method helps people to discover foot problems in early stages, when the problems are easier to treat;and how people feel about each method of examining their feet.
