Foot Self-care in Older Adults
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|ClinicalTrials.gov Identifier: NCT03656341|
Recruitment Status : Completed
First Posted : September 4, 2018
Last Update Posted : October 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Foot||Behavioral: 2 Feet 4 Life||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Foot Self-care in Older Adults Without Diabetes|
|Actual Study Start Date :||September 27, 2018|
|Actual Primary Completion Date :||July 15, 2019|
|Actual Study Completion Date :||September 17, 2019|
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.
- Foot Self-Care Knowledge Questionnaire [ Time Frame: Baseline, one month, three months, six months ]0-11 scale with higher numbers indicating more knowledge
- Foot Care Confidence Scale [ Time Frame: Baseline, one month, three months, six months ]12-60 scale with greater scores indicating greater self-efficacy
- 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
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03656341
|United States, Oklahoma|
|Broken Arrow Seniors|
|Broken Arrow, Oklahoma, United States, 74012|
|Owasso Community Center|
|Owasso, Oklahoma, United States, 74055|
|Principal Investigator:||Jennifer O'Connor||University of Missouri-Columbia|