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Foot Self-care in Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03656341
Recruitment Status : Completed
First Posted : September 4, 2018
Last Update Posted : October 25, 2019
Sponsor:
Information provided by (Responsible Party):
Jennifer O'Connor, University of Missouri-Columbia

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.

Condition or disease Intervention/treatment Phase
Foot Behavioral: 2 Feet 4 Life Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Foot Self-Care Knowledge Questionnaire [ Time Frame: Baseline, one month, three months, six months ]
    0-11 scale with higher numbers indicating more knowledge

  2. Foot Care Confidence Scale [ Time Frame: Baseline, one month, three months, six months ]
    12-60 scale with greater scores indicating greater self-efficacy

  3. 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

  4. 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


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Locations
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United States, Oklahoma
Broken Arrow Seniors
Broken Arrow, Oklahoma, United States, 74012
Owasso Community Center
Owasso, Oklahoma, United States, 74055
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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Principal Investigator: Jennifer O'Connor University of Missouri-Columbia
  Study Documents (Full-Text)

Documents provided by Jennifer O'Connor, University of Missouri-Columbia:
Informed Consent Form  [PDF] September 25, 2018

Additional Information:
Publications:
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

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Responsible Party: Jennifer O'Connor, PhD student, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT03656341    
Other Study ID Numbers: 2011705
First Posted: September 4, 2018    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jennifer O'Connor, University of Missouri-Columbia:
foot care
older adults
senior center
self-management
self-care