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Completed

NCT Number: NCT03656341

Foot Self-care in Older Adults

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.

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Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Broken Arrow Seniors, Broken Arrow, Oklahoma, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

2 Feet 4 Life

Behavioral

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.

Primary outcomes

  1. Foot Self-Care Knowledge Questionnaire

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

    0-11 scale with higher numbers indicating more knowledge

  2. Foot Care Confidence Scale

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

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

  3. 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

  4. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Official study title

Foot Self-care in Older Adults Without Diabetes

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 4, 2018
Registry last updated
Oct 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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