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Clinical Trials/NCT03656341
NCT03656341
Completed
Not Applicable

Foot Self-care in Older Adults Without Diabetes

University of Missouri-Columbia2 sites in 1 country32 target enrollmentSeptember 27, 2018
ConditionsFoot

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Foot
Sponsor
University of Missouri-Columbia
Enrollment
32
Locations
2
Primary Endpoint
Nottingham Assessment of Functional Foot Care
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

This pilot study will make a preliminary evaluation of the efficacy of 2 Feet 4 Life, a foot care self-management program, on foot care knowledge, foot care self-efficacy, foot care behaviors, and foot pain in community dwelling older adults without diabetes mellitus.

Detailed Description

One in three older adults have foot problems such as bunions, corns, calluses, foot pain, or nail disorders, but those problems are often ignored or overlooked until they threaten mobility or quality of life. With proper self-management, skin and nail problems can be addressed before they become severe; however, older adults without diabetes are not routinely informed of self-management techniques unless they consult a specialist. Targeting a foot care self-management program to community-dwelling older adults without diabetes may not only enhance foot function and preserve independence but also reach older adults with limited healthcare access. Study participants will be 24 nondiabetic older adults recruited from two Midwestern community senior centers. One community center will be randomized to receive the intervention, 2 Feet 4 Life, the other will be a true control group receiving no intervention. The 2 Feet 4 Life foot care self-management program is based on Social Cognitive Theory and will be delivered in four weekly, one-hour group sessions. The program includes self-management teaching, interactive lecture, and group activities, including instruction, demonstration, and practice of routine foot care. In addition to usual lecture and handouts, 2 Feet 4 Life will rely on group interaction, practice opportunities, and the provision of foot care supplies so participants can perform foot care at home. Program topics include appropriate foot hygiene and footwear, identification and treatment of common foot problems, demonstration of proper foot care with opportunities for practice and instructor feedback, and guidance in obtaining appropriate footwear. Outcome measures will be assessed pre-intervention, immediately post-intervention, three months post-intervention, and six months post-intervention. This will be the first study to test a nurse run, community-based, foot care self-management program for non-diabetic older adults.

Registry
clinicaltrials.gov
Start Date
September 27, 2018
End Date
September 17, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jennifer O'Connor

PhD student

University of Missouri-Columbia

Eligibility Criteria

Inclusion Criteria

  • 65 years of age or older
  • legally competent to sign informed consent
  • willing to participate in the study

Exclusion Criteria

  • self-reports of diabetes
  • non-traumatic amputation
  • legal blindness.
  • demonstrated inability to see and remove dot stickers on the feet
  • active ingrown toenails
  • absent pedal pulses
  • poor sensation as defined by the inability to feel more than 3 of 10 foot sites touched with a microfilament
  • regular visits to a healthcare professional for foot care
  • score of \<2 on the mental status screener.

Outcomes

Primary Outcomes

Nottingham Assessment of Functional Foot Care

Time Frame: Baseline, one month, three months, six months

Scale of 0-87 with higher scores revealing more appropriate foot self-care

Manchester Foot Pain and Disability INdex

Time Frame: Baseline, one month, three months, six months

0-34 scale with higher scores indicating more pain and disability

Foot Self-Care Knowledge Questionnaire

Time Frame: Baseline, one month, three months, six months

0-11 scale with higher numbers indicating more knowledge

Foot Care Confidence Scale

Time Frame: Baseline, one month, three months, six months

12-60 scale with greater scores indicating greater self-efficacy

Secondary Outcomes

  • Foot Health Score(Baseline, one month, three months, six months)

Study Sites (2)

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