Using a Smartphone App to Aid in Functional Mobility Return Following Total Knee Arthroplasty

NCT03607461 | Unknown

• 1 other identifier: 4357
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Traditional home health care for individuals recovering from unilateral TKA is expensive and provides a higher level of service than most individuals, aged 45 to 64, require. Use of smartphone technology has the potential to drive down costs while maintaining outcomes for this patient population. The proposed randomized controlled trial would determine the efficacy and proper dose-response of a smartphone app to reduce costs and maintain outcomes for the desired patient population compared to traditional home care.

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (2)

• Total Knee Range of Motion (ROM) change

  Initial knee ROM will be taken within 48 hours of discharge home from hospital. Final knee ROM will be taken upon participant no longer being homebound and expressing readiness to begin outpatient physical therapy

  Baseline and through study completion, usually 2 to 4 weeks

• Western Ontario and McMaster Universities Osteoarthritis Index (shortened version)

  Questionnaire to be completed by participant at time of initial data collection described above. Final questionnaire also completed as described above

  Baseline and through study completion, usually 2 to 4 weeks

Secondary Outcomes (1)

• Self-Reported App Engagement

  Data collected at final assessment, usually 2 to 4 weeks

Study Arms (2)

Smartphone App Users

EXPERIMENTAL

Smartphone App Users will receive important information and prescriptive exercise via a smartphone app upon returning home from the hospital following total knee arthroplasty

Device: Smartphone App

Home Health Users

ACTIVE COMPARATOR

Home Health Users will have already undergone traditional home health physical therapy and/or skilled nursing for the purpose of comparing outcomes

Combination Product: Control Group

Interventions

Smartphone App DEVICE

Smartphone App Users will engage with the app at least daily and follow along with the prescriptive exercises as instructed.

Smartphone App Users

Control Group COMBINATION_PRODUCT

Home Health users will have received traditional home health physical therapy and skilled nursing services.

Home Health Users

Eligibility Criteria

• Age: 45 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• participants aged 45 to 64
• unilateral TKA
• subject discharged directly to home from the hospital

You may not qualify if:

• subject does not engage with the app within 24 hours of discharge from the hospital
• subject neglects to engage with the app over any 24-hour period during the study
• subject is readmitted to the hospital at any point during the home bound portion of their recovery

Sponsors & Collaborators

• Lagniappe Physical Therapy: lead

Study Sites (1)

Office

Shreveport, Louisiana, 71106, United States

RECRUITING

Related Publications (5)

• Whitehouse SL, Lingard EA, Katz JN, Learmonth ID. Development and testing of a reduced WOMAC function scale. J Bone Joint Surg Br. 2003 Jul;85(5):706-11.

  PMID: 12892194 RESULT

• Abbott JH, Hobbs C, Gwynne-Jones D; MOA Trial Team. The ShortMAC: Minimum Important Change of a Reduced Version of the Western Ontario and McMaster Universities Osteoarthritis Index. J Orthop Sports Phys Ther. 2018 Feb;48(2):81-86. doi: 10.2519/jospt.2018.7676. Epub 2017 Oct 21.

  PMID: 29056072 RESULT

• Weinstein AM, Rome BN, Reichmann WM, Collins JE, Burbine SA, Thornhill TS, Wright J, Katz JN, Losina E. Estimating the burden of total knee replacement in the United States. J Bone Joint Surg Am. 2013 Mar 6;95(5):385-92. doi: 10.2106/JBJS.L.00206.

  PMID: 23344005 RESULT

• Losina E, Thornhill TS, Rome BN, Wright J, Katz JN. The dramatic increase in total knee replacement utilization rates in the United States cannot be fully explained by growth in population size and the obesity epidemic. J Bone Joint Surg Am. 2012 Feb 1;94(3):201-7. doi: 10.2106/JBJS.J.01958.

  PMID: 22298051 RESULT

• Bleijenberg N, Smith AK, Lee SJ, Cenzer IS, Boscardin JW, Covinsky KE. Difficulty Managing Medications and Finances in Older Adults: A 10-year Cohort Study. J Am Geriatr Soc. 2017 Jul;65(7):1455-1461. doi: 10.1111/jgs.14819. Epub 2017 Apr 5.

  PMID: 28378345 RESULT

Related Links

• Mobile Fact Sheet. Pew Research Center. 2018 Feb 5.
• Louisiana Home Health State Regulations. Department of Health and Hospitals. Office of the Secretary. Bureau of Health Services Financing. Louisiana Register. Vol 27, No 12, 2001 Dec 20. Accessed online

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Eric M Rippetoe, DPT

  Owner of Lagniappe Physical Therapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric M Rippetoe, DPT

CONTACT

318-560-5726; eric@lagniappept.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Control group will consist of those who meet the inclusion criteria and have received traditional home health services following total knee arthroplasty (TKA). Intervention group participants who meet the inclusion criteria will receive a smartphone app instead of traditional home health services to aid in knee mobility recovery following TKA

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: July 31, 2018
• Study Start: July 1, 2018
• Primary Completion: August 1, 2018
• Study Completion: September 1, 2018
• Last Updated: July 31, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)