NCT03656341

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 4, 2018

Completed
23 days until next milestone

Study Start

First participant enrolled

September 27, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2019

Completed
Last Updated

October 25, 2019

Status Verified

October 1, 2019

Enrollment Period

10 months

First QC Date

August 30, 2018

Last Update Submit

October 23, 2019

Conditions

Foot

Keywords

foot careolder adultssenior centerself-managementself-care

Outcome Measures

Primary Outcomes (4)

  • Foot Self-Care Knowledge Questionnaire

    0-11 scale with higher numbers indicating more knowledge

    Baseline, one month, three months, six months

  • Foot Care Confidence Scale

    12-60 scale with greater scores indicating greater self-efficacy

    Baseline, one month, three months, six months

  • 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

  • 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 Outcomes (1)

  • Foot Health Score

    Baseline, one month, three months, six months

Study Arms (3)

2 Feet 4 Life

EXPERIMENTAL

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

True control group

NO INTERVENTION

Will complete the same four assessment visits as the intervention group.

Bias control group

NO INTERVENTION

Will complete outcome assessments at baseline and the final assessment.

Interventions

2 Feet 4 LifeBEHAVIORAL

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.

2 Feet 4 Life

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • years of age or older
  • legally competent to sign informed consent
  • willing to participate in the study

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Broken Arrow Seniors

Broken Arrow, Oklahoma, 74012, United States

Location

Owasso Community Center

Owasso, Oklahoma, 74055, United States

Location

Related 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.

    PMID: 24929632BACKGROUND

  • 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. doi: 10.1080/09638280500030506.

    PMID: 16096244BACKGROUND

  • 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.

    PMID: 20538970BACKGROUND

  • 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. doi: 10.1016/s0304-3959(99)00263-8.

    PMID: 10692609BACKGROUND

  • 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(Suppl 1):S144-53. doi: 10.2337/dc14-S144. No abstract available.

    PMID: 24357210BACKGROUND

  • 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.

    PMID: 22034121BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 22522517BACKGROUND

  • 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.

    PMID: 22835017BACKGROUND

  • 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. doi: 10.1016/s0895-4356(03)00197-5.

    PMID: 14615000BACKGROUND

Study Officials

  • Jennifer O'Connor

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

August 30, 2018

First Posted

September 4, 2018

Study Start

September 27, 2018

Primary Completion

July 15, 2019

Study Completion

September 17, 2019

Last Updated

October 25, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)