Nonvisual Foot Examination for People With Diabetes and Visual Impairment

Study Overview
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Brief Summary
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Because people who have both diabetes and visual impairment have high risk for foot problems, prevention of ulcers and amputation is a high priority. Usual care in diabetes self-management education (DSME) is to teach them to seek sighted assistance for regular foot examination, yet clinical experience suggests that this advice is seldom heeded. One possible solution is to teach use of the nonvisual senses of touch and smell for a systematic, thorough foot self-examination. The purpose of this pilot study was to compare the efficacy, acceptability, and feasibility of nonvisual foot examination with usual care (examination of the visually impaired person's feet by a sighted family member or friend).

Official Title
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Nonvisual Foot Examination for People With Diabetes and Visual Impairment

Conditions
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Diabetes, Visual Impairment

Intervention / Treatment
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* Behavioral: DSME with Nonvisual Foot Examination
* Behavioral: DSME with Usual Foot Examination Instruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: over age 18 diagnosed with either type 1 or type 2 diabetes stated they had visual impairment Exclusion Criteria: unable to pass a brief decisional capacity test had a score above 80 on the near vision scale of the National Eye Institute Visual Functioning Questionnaire had bilateral lower extremity amputations by self-report were unable to sense light touch on two or more fingers or either hand

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>DSME with Nonvisual Foot Examination | Behavioral: DSME with Nonvisual Foot Examination<br>* Diabetes Self-Management Education (DSME) with Nonvisual Foot Examination included comprehensive DSME taught by Certified Diabetes Educators that included instruction in nonvisual self-examination of feet using the senses of touch and smell.<br>|
| Active Comparator: Comparison<br>DSME with Usual Foot Examination Instruction | Behavioral: DSME with Usual Foot Examination Instruction<br>* DSME with usual foot examination instruction was comprehensive diabetes self management education taught by Certified Diabetes Educators that included usual care instructions for examination for feet at home by visually impaired persons, i.e., to have a sighted person check the feet regularly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of foot examination at home | number of times that the enrolled participant or someone else examined the person's feet at home during the study period | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New foot problems discovered at home | total number of new foot problems reported to podiatrists as having been discovered at home by the participant or someone else examining the person's feet | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, visual impairment, foot care, diabetes self-management education