Nonvisual Foot Examination for People With Diabetes and Visual Impairment
Primary Purpose
Diabetes, Visual Impairment
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DSME with Nonvisual Foot Examination
DSME with Usual Foot Examination Instruction
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes focused on measuring diabetes, visual impairment, foot care, diabetes self-management education
Eligibility Criteria
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
Sites / Locations
- Case Western Reserve University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental
Comparison
Arm Description
DSME with Nonvisual Foot Examination
DSME with Usual Foot Examination Instruction
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02102958
First Posted
March 31, 2014
Last Updated
March 31, 2014
Sponsor
Case Western Reserve University
1. Study Identification
Unique Protocol Identification Number
NCT02102958
Brief Title
Nonvisual Foot Examination for People With Diabetes and Visual Impairment
Official Title
Nonvisual Foot Examination for People With Diabetes and Visual Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Case Western Reserve University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Visual Impairment
Keywords
diabetes, visual impairment, foot care, diabetes self-management education
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
DSME with Nonvisual Foot Examination
Arm Title
Comparison
Arm Type
Active Comparator
Arm Description
DSME with Usual Foot Examination Instruction
Intervention Type
Behavioral
Intervention Name(s)
DSME with Nonvisual Foot Examination
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
DSME with Usual Foot Examination Instruction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of foot examination at home
Description
number of times that the enrolled participant or someone else examined the person's feet at home during the study period
Time Frame
6 months
Secondary Outcome Measure Information:
Title
New foot problems discovered at home
Description
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
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Total new foot problems
Description
total number of foot problems documented by the podiatrist at podiatry visit
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann S Williams, PhD
Organizational Affiliation
Case Western Reserve University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
12. IPD Sharing Statement
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Nonvisual Foot Examination for People With Diabetes and Visual Impairment
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