Foot Clinical Trial
Official title:
Foot Self-care in Older Adults Without Diabetes
Verified date | October 2019 |
Source | University of Missouri-Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Broken Arrow Seniors | Broken Arrow | Oklahoma |
United States | Owasso Community Center | Owasso | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
University of Missouri-Columbia |
United States,
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
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 |
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