Foot Self-care in Older Adults

Foot Clinical Trial

Official title:

Foot Self-care in Older Adults Without Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03656341
• Other study ID #: 2011705
• Status: Completed
• Phase: N/A
• Start date: September 27, 2018
• Est. completion date: September 17, 2019

Study information

• Verified date: October 2019
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 17, 2019
• Est. primary completion date: July 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Foot

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.

Locations

Country	Name	City	State
United States	Broken Arrow Seniors	Broken Arrow	Oklahoma
United States	Owasso Community Center	Owasso	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

References & Publications (10)

Baba M, Duff J, Foley L, Davis WA, Davis TM. A comparison of two methods of foot health education: the Fremantle Diabetes Study Phase II. Prim Care Diabetes. 2015 Apr;9(2):155-62. doi: 10.1016/j.pcd.2014.05.004. Epub 2014 Jun 12. — View Citation

Barr EL, Browning C, Lord SR, Menz HB, Kendig H. Foot and leg problems are important determinants of functional status in community dwelling older people. Disabil Rehabil. 2005 Aug 19;27(16):917-23. — View Citation

Castillo A, Giachello A, Bates R, Concha J, Ramirez V, Sanchez C, Pinsker E, Arrom J. Community-based Diabetes Education for Latinos: The Diabetes Empowerment Education Program. Diabetes Educ. 2010 Jul-Aug;36(4):586-94. doi: 10.1177/0145721710371524. Epub 2010 Jun 10. — View Citation

Garrow AP, Papageorgiou AC, Silman AJ, Thomas E, Jayson MI, Macfarlane GJ. Development and validation of a questionnaire to assess disabling foot pain. Pain. 2000 Mar;85(1-2):107-13. — View Citation

Haas L, Maryniuk M, Beck J, Cox CE, Duker P, Edwards L, Fisher EB, Hanson L, Kent D, Kolb L, McLaughlin S, Orzeck E, Piette JD, Rhinehart AS, Rothman R, Sklaroff S, Tomky D, Youssef G; 2012 Standards Revision Task Force. National standards for diabetes self-management education and support. Diabetes Care. 2014 Jan;37 Suppl 1:S144-53. doi: 10.2337/dc14-S144. — View Citation

Mickle KJ, Munro BJ, Lord SR, Menz HB, Steele JR. Cross-sectional analysis of foot function, functional ability, and health-related quality of life in older people with disabling foot pain. Arthritis Care Res (Hoboken). 2011 Nov;63(11):1592-8. doi: 10.1002/acr.20578. — View Citation

Senussi, M., Lincoln, N., & Jeffcoate, W. (2011). Psychometric properties of the Nottingham Assessment of Functional Footcare (NAFF). International Journal of Therapy and Rehabilitation, 18(6), 330-334. https://doi.org/10.12968/ijtr.2011.18.6.330

Snider KT, Seffinger MA, Ferrill HP, Gish EE. Trainer-to-student ratios for teaching psychomotor skills in health care fields, as applied to osteopathic manipulative medicine. J Am Osteopath Assoc. 2012 Apr;112(4):182-7. Review. Erratum in: J Am Osteopath Assoc. 2012 Jun;112(6):385. — View Citation

Stolt M, Suhonen R, Puukka P, Viitanen M, Voutilainen P, Leino-Kilpi H. Foot health and self-care activities of older people in home care. J Clin Nurs. 2012 Nov;21(21-22):3082-95. doi: 10.1111/j.1365-2702.2012.04223.x. Epub 2012 Jul 27. — View Citation

Waxman R, Woodburn H, Powell M, Woodburn J, Blackburn S, Helliwell P. FOOTSTEP: a randomized controlled trial investigating the clinical and cost effectiveness of a patient self-management program for basic foot care in the elderly. J Clin Epidemiol. 2003 Nov;56(11):1092-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Foot Self-Care Knowledge Questionnaire	0-11 scale with higher numbers indicating more knowledge	Baseline, one month, three months, six months
Primary	Foot Care Confidence Scale	12-60 scale with greater scores indicating greater self-efficacy	Baseline, one month, three months, six months
Primary	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
Primary	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	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

External Links

•   National Diabetes Statistics report