Nonvisual Foot Inspection for People With Visual Imapirment

This study has been completed.
Sponsor:
Collaborator:
Kent State University
Information provided by (Responsible Party):
Ann S. Williams, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT01822717
First received: March 28, 2013
Last updated: NA
Last verified: March 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Diabetes
Visual Impairment
Behavioral: Nonvisual foot inspection
Behavioral: Usual Care

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Nonvisual Foot Inspection for People With Visual Impairment

Resource links provided by NLM:


Further study details as provided by Case Western Reserve University:

Primary Outcome Measures:
  • Days per week participants performed foot inspection [ Time Frame: every 2 months for 1 year ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: every 3 months for 1 year ] [ Designated as safety issue: Yes ]
    Number of foot problems discovered by podiatrists or at home by participants


Other Outcome Measures:
  • Acceptability [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Qualitative information from focus groups


Enrollment: 30
Study Start Date: September 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nonvisual foot inspection
Instruction for nonvisual foot inspection included in comprehensive diabetes self-management education
Behavioral: 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
Other Name: Multi-SAFE (Multiple Senses And Foot Examination)
Active Comparator: Usual Care for foot inspection
Usual instruction for foot care included in comprehensive diabetes self-management education
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
Other Name: Standard foot care instructions

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01822717

Locations
United States, Ohio
Cleveland Foot and Ankle Institute
Cleveland, Ohio, United States, 44103
Sponsors and Collaborators
Case Western Reserve University
Kent State University
Investigators
Principal Investigator: Ann S Williams, PhD Case Western Reserve University
  More Information

No publications provided

Responsible Party: Ann S. Williams, Research Associate Professor, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01822717     History of Changes
Other Study ID Numbers: BRIDGES- ST09 49
Study First Received: March 28, 2013
Last Updated: March 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Case Western Reserve University:
Diabetes
Visual Impairment
Blindness
Foot Care
Self-Management

Additional relevant MeSH terms:
Diabetes Mellitus
Vision, Low
Vision Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014