Nonvisual Foot Examination for People With Diabetes and Visual Impairment

NCT02102958 | Completed DMC

• 1 other identifier: R21NR012513
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Diabetes; Visual Impairment

Keywords

diabetes; visual impairment; foot care; diabetes self-management education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• New foot problems discovered at home

  6 months

Other Outcomes (1)

• Total new foot problems

  6 months

Study Arms (2)

Experimental

EXPERIMENTAL

DSME with Nonvisual Foot Examination

Behavioral: DSME with Nonvisual Foot Examination

Comparison

ACTIVE COMPARATOR

DSME with Usual Foot Examination Instruction

Behavioral: DSME with Usual Foot Examination Instruction

Interventions

DSME with Nonvisual Foot Examination BEHAVIORAL

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.

Experimental

DSME with Usual Foot Examination Instruction BEHAVIORAL

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.

Comparison

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• over age 18
• diagnosed with either type 1 or type 2 diabetes
• stated they had visual impairment

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Western Reserve University: lead

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Vision Disorders

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ann S Williams, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2014
• First Posted: April 3, 2014
• Study Start: July 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 14, 2023

Record last verified: 2014-03

Locations

US (1)