Foot Self-care in Older Adults

October 23, 2019 updated by: Jennifer O'Connor, University of Missouri-Columbia

Foot Self-care in Older Adults Without Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Broken Arrow, Oklahoma, United States, 74012
        • Broken Arrow Seniors
      • Owasso, Oklahoma, United States, 74055
        • Owasso Community Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2 Feet 4 Life
Intervention group will receive one hour intervention weekly for four consecutive weeks. Outcomes will be measured at baseline (before the intervention), immediately after the intervention (1 month), three months post-intervention, and six months post-intervention
Behavioral: 2 Feet 4 Life
2 Feet 4 Life consists of four weekly group intervention sessions of one hour each. 2 Feet 4 Life includes self-management teaching, interactive lecture, and group activities, including instruction and demonstration of routine foot care. The program includes education regarding appropriate footwear and how to find it, evidenced based practices on hygiene, skin care and self-care of the lower extremities, nail trimming and filing, and care of common foot problems.
No Intervention: True control group
Will complete the same four assessment visits as the intervention group.
No Intervention: Bias control group
Will complete outcome assessments at baseline and the final assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Foot Self-Care Knowledge Questionnaire
Time Frame: Baseline, one month, three months, six months
0-11 scale with higher numbers indicating more knowledge
Baseline, one month, three months, six months
Foot Care Confidence Scale
Time Frame: Baseline, one month, three months, six months
12-60 scale with greater scores indicating greater self-efficacy
Baseline, one month, three months, six months
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
Baseline, one month, three months, six months
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
Baseline, one month, three months, six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Foot Health Score
Time Frame: Baseline, one month, three months, six months
Scale 0-90 provider assessment of foot problems. Higher score indicate more severe foot problems and greater severity.
Baseline, one month, three months, six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri-Columbia

Investigators

  • Principal Investigator: Jennifer O'Connor, University of Missouri-Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2018

Primary Completion (Actual)

July 15, 2019

Study Completion (Actual)

September 17, 2019

Study Registration Dates

First Submitted

August 30, 2018

First Submitted That Met QC Criteria

August 30, 2018

First Posted (Actual)

September 4, 2018

Study Record Updates

Last Update Posted (Actual)

October 25, 2019

Last Update Submitted That Met QC Criteria

October 23, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2011705

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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