Clinical trial NCT03656341: Foot Self-care in Older Adults
Official title: Foot Self-care in Older Adults Without Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Foot
Keywords: foot care
older adults
senior center
self-management
self-care
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2018-09-04
Enrollment: 32
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Foot Self-Care Knowledge Questionnaire
timeFrame: Baseline, one month, three months, six months
measure: Foot Care Confidence Scale
timeFrame: Baseline, one month, three months, six months
measure: Nottingham Assessment of Functional Foot Care
timeFrame: Baseline, one month, three months, six months
measure: Manchester Foot Pain and Disability INdex
timeFrame: Baseline, one month, three months, six months
Secondary outcomes:
measure: Foot Health Score
timeFrame: Baseline, one month, three months, six months
Other outcomes:
Locations:
city: Broken Arrow
country: United States
facility: Broken Arrow Seniors
state: Oklahoma
city: Owasso
country: United States
facility: Owasso Community Center
state: Oklahoma
Study officials:
affiliation: University of Missouri-Columbia
name: Jennifer O'Connor
role: PRINCIPAL_INVESTIGATOR
References:
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