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临床试验/NCT03656341
NCT03656341已完成不适用

Foot Self-care in Older Adults Without Diabetes

University of Missouri-Columbia4 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2018年9月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
4
主要终点
Nottingham Assessment of Functional Foot Care

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

2 Feet 4 Life

Experimental

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

干预措施: 2 Feet 4 Life (Behavioral)

True control group

No Intervention

Will complete the same four assessment visits as the intervention group.

Bias control group

No Intervention

Will complete outcome assessments at baseline and the final assessment.

结局指标

主要结局

Nottingham Assessment of Functional Foot Care

时间窗: 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

时间窗: Baseline, one month, three months, six months

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

Foot Self-Care Knowledge Questionnaire

时间窗: Baseline, one month, three months, six months

0-11 scale with higher numbers indicating more knowledge

Foot Care Confidence Scale

时间窗: Baseline, one month, three months, six months

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

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer O'Connor

PhD student

University of Missouri-Columbia

研究点 (4)

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