Nonvisual Foot Inspection for People With Visual Impairment

NCT ID: NCT01822717

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-09-30

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

Conditions

Diabetes; Visual Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Nonvisual foot inspection

Instruction for nonvisual foot inspection included in comprehensive diabetes self-management education

Group Type: EXPERIMENTAL

Nonvisual foot inspection

Intervention Type: BEHAVIORAL

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

Usual Care for foot inspection

Usual instruction for foot care included in comprehensive diabetes self-management education

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: BEHAVIORAL

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

Interventions

Nonvisual foot inspection

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

Intervention Type: BEHAVIORAL

Usual Care

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Multi-SAFE (Multiple Senses And Foot Examination); Standard foot care instructions

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kent State University

OTHER

Sponsor Role: collaborator

Case Western Reserve University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ann S Williams, PhD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Locations

Cleveland Foot and Ankle Institute

Cleveland, Ohio, United States

Countries

United States

References

Williams A. Appraising the Multi-SAFE approach to low vision and diabetes: a simple technique for saving feet. Diabetes Voice 56(Special Issue 1):14-17, 2011

Reference Type: BACKGROUND

Other Identifiers

BRIDGES- ST09 49

Identifier Type: -

Identifier Source: org_study_id