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Nonvisual Foot Inspection for People With Visual Imapirment

Primary Purpose

Diabetes, Visual Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nonvisual foot inspection
Usual Care
Sponsored by
Case Western Reserve University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes focused on measuring Diabetes, Visual Impairment, Blindness, Foot Care, Self-Management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Foot and Ankle Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nonvisual foot inspection

Usual Care for foot inspection

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Number of foot problems discovered
Number of foot problems discovered by podiatrists or at home by participants

Full Information

First Posted
March 28, 2013
Last Updated
March 28, 2013
Sponsor
Case Western Reserve University
Collaborators
Kent State University
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1. Study Identification

Unique Protocol Identification Number
NCT01822717
Brief Title
Nonvisual Foot Inspection for People With Visual Imapirment
Official Title
Nonvisual Foot Inspection for People With Visual Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Case Western Reserve University
Collaborators
Kent State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

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, Blindness, Foot Care, Self-Management

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nonvisual foot inspection
Arm Type
Experimental
Arm Description
Instruction for nonvisual foot inspection included in comprehensive diabetes self-management education
Arm Title
Usual Care for foot inspection
Arm Type
Active Comparator
Arm Description
Usual instruction for foot care included in comprehensive diabetes self-management education
Intervention Type
Behavioral
Intervention Name(s)
Nonvisual foot inspection
Other Intervention Name(s)
Multi-SAFE (Multiple Senses And Foot Examination)
Intervention Description
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
Intervention Name(s)
Usual Care
Other Intervention Name(s)
Standard foot care instructions
Intervention Description
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
Primary Outcome Measure Information:
Title
Days per week participants performed foot inspection
Description
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)
Time Frame
every 2 months for 1 year
Secondary Outcome Measure Information:
Title
Number of foot problems discovered
Description
Number of foot problems discovered by podiatrists or at home by participants
Time Frame
every 3 months for 1 year
Other Pre-specified Outcome Measures:
Title
Acceptability
Description
Qualitative information from focus groups
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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
Cleveland Foot and Ankle Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44103
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
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Nonvisual Foot Inspection for People With Visual Imapirment

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