Foot Self-care in Older Adults

Study Overview
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Brief Summary
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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
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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.

Official Title
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Foot Self-care in Older Adults Without Diabetes

Conditions
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Foot

Intervention / Treatment
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* Behavioral: 2 Feet 4 Life


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2 Feet 4 Life<br>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<br>* 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.<br>|
| No Intervention: True control group<br>Will complete the same four assessment visits as the intervention group. | |
| No Intervention: Bias control group<br>Will complete outcome assessments at baseline and the final assessment. | |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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foot care, older adults, senior center, self-management, self-care