Nonvisual Foot Inspection for People With Visual Imapirment

Study Overview
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Brief Summary
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The purpose of this study was to find out whether a method of nonvisual foot inspection, using the senses of touch and smell, helps people with diabetes and visual impairment to find new foot problems when they are in early, easily-treated stages. All people in the study had regular foot inspections by podiatrists. The results include how people feel about the method, whether they actually did check their feet it, and whether the method helped them to discover foot problems themselves.

Detailed Description
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Data gathered over the course of 1 year: bimonthly phone calls to ask about foot care practices at home over the last week a baseline comprehensive foot evaluation and 4 additional comprehensive evaluations every 3 months Qualitative data: - Focus groups immediately after comprehensive diabetes self-management education, and 1 year later, to determine acceptability of foot care procedures and patient perceptions about effectiveness

Official Title
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Nonvisual Foot Inspection for People With Visual Impairment

Conditions
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Diabetes, Visual Impairment

Intervention / Treatment
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* Behavioral: Nonvisual foot inspection
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over age 18 Diagnosed with diabetes (either type 1 or type 2) Having visual impairment Exclusion Criteria: Self-reported numbness in hands Inability to pass a brief screening for decisional capacity

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nonvisual foot inspection<br>Instruction for nonvisual foot inspection included in comprehensive diabetes self-management education | Behavioral: Nonvisual foot inspection<br>* Teaching use of nonvisual senses (tactile and olfactory) to empower people with diabetes and visual impairment to perform a systematic self-examination of their own feet<br>* Other names: Multi-SAFE (Multiple Senses And Foot Examination);|
| Active Comparator: Usual Care for foot inspection<br>Usual instruction for foot care included in comprehensive diabetes self-management education | Behavioral: Usual Care<br>* Standard instructions for foot care for people with visual impairment include advice to have a sighted family member or friend check the person's feet regularly<br>* Other names: Standard foot care instructions;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days per week participants performed foot inspection | Number of days in the last week each participants reported checking their feet for problems, using nonvisual methods (experimental group) or with assistance form someone else (comparison group) | every 2 months for 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of foot problems discovered | Number of foot problems discovered by podiatrists or at home by participants | every 3 months for 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Visual Impairment, Blindness, Foot Care, Self-Management