Nonvisual Foot Inspection for People With Visual Imapirment

Not Applicable

Completed

• Conditions: Diabetes; Visual Impairment
• Interventions: Behavioral: Nonvisual foot inspection; Behavioral: Usual Care

• Registration Number: NCT01822717
• Lead Sponsor: Case Western Reserve University

Brief Summary

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

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

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-03
• Study First Submitted: 2013-03-28
• Study First Submitted QC: 2013-03-28
• Last Update Submitted: 2013-03-28
• Study First Posted: 2013-04-02
• Last Update Posted: 2013-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nonvisual foot inspection	Nonvisual foot inspection	Instruction for nonvisual foot inspection included in comprehensive diabetes self-management education
Usual Care for foot inspection	Usual Care	Usual instruction for foot care included in comprehensive diabetes self-management education

Primary Outcome Measures

Name	Time	Method
Days per week participants performed foot inspection	every 2 months for 1 year	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)

Secondary Outcome Measures

Name	Time	Method
Number of foot problems discovered	every 3 months for 1 year	Number of foot problems discovered by podiatrists or at home by participants

Trial Locations

Locations (1)

Cleveland Foot and Ankle Institute; 🇺🇸 Cleveland, Ohio, United States