Internet Enhanced, Patient-Centered Orthopedic Care: A Prospective, Randomized, Controlled Pilot Trial

Knee Injuries Clinical Trial

Official title:

Phase I Study Comparing Internet Delivered Home Exercise Programs to Standard Orthopedic Care and Outpatient Physical Therapy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02025400
• Other study ID #: eRehab101
• Status: Completed
• Phase: Phase 1
• First received: December 26, 2013
• Last updated: December 31, 2013
• Start date: July 2012
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Charlotte Sports Medicine Institute, PA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The investigators have previously reported on patient utilization of an eRehab patient education web portal that utilizes streaming, clinician prescribed video instruction to motivate and inform patients in self-care of their orthopedic condition, focusing on the importance of a home exercise program. The greatest barrier to patient use of this web-based home exercise treatment plan was the initial access to the program. The purpose of this study is to compare an Internet-based patient education rehab portal (eRehab) to formal physical therapy (PT) in terms of patient costs and outcomes.

Description:

This is a prospective, randomized, controlled pilot study. Twenty-four patients who were candidates for a knee or shoulder orthopedic outpatient physical therapy referral were randomized to a 6-week treatment course of either PT or eRehab. Patients were evaluated for outcome scores (KOOS or DASH), pain NRS-11 scores, patient subjective outcomes and cost of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patient diagnosed by board certified orthopedic surgeon to be in need of formal physical therapy referral

• had the ability to access and use the Internet and email

• English-speaking

• non-pregnant adults

• had not received formal physical therapy for their current diagnosis

Exclusion Criteria:

• work-related injuries

• pain NRS-11 score greater than or equal to 6

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Injuries
• Meniscus Tear
• Patellofemoral Pain
• Rotator Cuff Disease
• Shoulder Injuries

Intervention

Other:
• eRehab
Growth in e-Health applications, defined as any computer or Internet application integrated into health services, has resulted in the development of treatment strategies to improve healthcare while reducing costs. The utilization of e-Health to provide a rehabilitative intervention has recently been identified in the cardiac literature as "e-rehabilitation" or "eRehab." This study specifically compares an orthopedic eRehab Internet application to standard outpatient physical therapy as an adjunct in the treatment of non-complicated knee and shoulder disorders.
• Formal Physical Therapy
This intervention involves referral to a licensed physical therapist or supervised ATC-L.

Locations

Country	Name	City	State
United States	Charlotte Sports Medicine Institute	Charlotte	North Carolina
United States	Advanced Orthopaedic Specialists	Prince Frederick	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Charlotte Sports Medicine Institute, PA	Advanced Orthopedic Specialists, The Orthopaedic Center

Country where clinical trial is conducted

United States, 

References & Publications (24)

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APTA Presentation to House Ways and Means Committee, 2011

Burden of Musculoskeletal Diseases in the United States: Prevalence, Societal and Economic Cost. Rosemont, IL, American Academy of Orthopaedic Surgeons. February 2008.

Deyle GD, Allison SC, Matekel RL, Ryder MG, Stang JM, Gohdes DD, Hutton JP, Henderson NE, Garber MB. Physical therapy treatment effectiveness for osteoarthritis of the knee: a randomized comparison of supervised clinical exercise and manual therapy proced — View Citation

Eng TR. The eHealth Landscape: A Terrain Map of Emerging Information and Communication Technologies in Health and Health Care. Princeton, NJ: The Robert Wood Johnson Foundation, 2001.

Farley FA, Weinstein SL. The case for patient-centered care in orthopaedics. J Am Acad Orthop Surg. 2006 Aug;14(8):447-51. — View Citation

Fatehi F, Wootton R. Telemedicine, telehealth or e-health? A bibliometric analysis of the trends in the use of these terms. J Telemed Telecare. 2012 Dec;18(8):460-4. doi: 10.1258/jtt.2012.GTH108. Epub 2012 Dec 3. — View Citation

Galea MP, Levinger P, Lythgo N, Cimoli C, Weller R, Tully E, McMeeken J, Westh R. A targeted home- and center-based exercise program for people after total hip replacement: a randomized clinical trial. Arch Phys Med Rehabil. 2008 Aug;89(8):1442-7. doi: 10 — View Citation

Grant JA, Mohtadi NG, Maitland ME, Zernicke RF. Comparison of home versus physical therapy-supervised rehabilitation programs after anterior cruciate ligament reconstruction: a randomized clinical trial. Am J Sports Med. 2005 Sep;33(9):1288-97. Epub 2005 — View Citation

Helwig AL, Lovelle A, Guse CE, Gottlieb MS. An office-based Internet patient education system: a pilot study. J Fam Pract. 1999 Feb;48(2):123-7. — View Citation

Hill AM, McPhail S, Hoffmann T, Hill K, Oliver D, Beer C, Brauer S, Haines TP. A randomized trial comparing digital video disc with written delivery of falls prevention education for older patients in hospital. J Am Geriatr Soc. 2009 Aug;57(8):1458-63. do — View Citation

Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996 Jun;29(6):602-8. Erratum in: Am J I — View Citation

Jolly K, Taylor R, Lip GY, Greenfield S, Raftery J, Mant J, Lane D, Jones M, Lee KW, Stevens A. The Birmingham Rehabilitation Uptake Maximisation Study (BRUM). Home-based compared with hospital-based cardiac rehabilitation in a multi-ethnic population: co — View Citation

Ko V, Naylor J, Harris I, Crosbie J, Yeo A, Mittal R. One-to-one therapy is not superior to group or home-based therapy after total knee arthroplasty: a randomized, superiority trial. J Bone Joint Surg Am. 2013 Nov 6;95(21):1942-9. doi: 10.2106/JBJS.L.009 — View Citation

Kuhn JE. Exercise in the treatment of rotator cuff impingement: a systematic review and a synthesized evidence-based rehabilitation protocol. J Shoulder Elbow Surg. 2009 Jan-Feb;18(1):138-60. doi: 10.1016/j.jse.2008.06.004. Epub 2008 Oct 2. Review. — View Citation

Mazzuca SA, Brandt KD, Katz BP, Dittus RS, Freund DA, Lubitz R, Hawker G, Eckert G. Comparison of general internists, family physicians, and rheumatologists managing patients with symptoms of osteoarthritis of the knee. Arthritis Care Res. 1997 Oct;10(5): — View Citation

McCarthy CJ, Mills PM, Pullen R, Richardson G, Hawkins N, Roberts CR, Silman AJ, Oldham JA. Supplementation of a home-based exercise programme with a class-based programme for people with osteoarthritis of the knees: a randomised controlled trial and heal — View Citation

Paul JJ, Rolfes K, Herron B, Rouse J. Orthopedic eRehab: An Assessment of Patient Utilization of Internet-based Home Exercise Programs. Submitted to Am J Sports Med.

Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug;28(2):88-96. — View Citation

Rozental TD, Bozentka DJ, Beredjiklian PK. Patient education through the Internet: academic and private practice sites. Clin Orthop Relat Res. 2004 Apr;(421):50-3. — View Citation

Russell TG, Buttrum P, Wootton R, Jull GA. Internet-based outpatient telerehabilitation for patients following total knee arthroplasty: a randomized controlled trial. J Bone Joint Surg Am. 2011 Jan 19;93(2):113-20. doi: 10.2106/JBJS.I.01375. — View Citation

Simek EM, McPhate L, Haines TP. Adherence to and efficacy of home exercise programs to prevent falls: a systematic review and meta-analysis of the impact of exercise program characteristics. Prev Med. 2012 Oct;55(4):262-75. doi: 10.1016/j.ypmed.2012.07.00 — View Citation

Tunay VB, Baltaci G, Atay AO. Hospital-based versus home-based proprioceptive and strengthening exercise programs in knee osteoarthritis. Acta Orthop Traumatol Turc. 2010;44(4):270-7. doi: 10.3944/AOTT.2010.2306. — View Citation

Veroff DR, Sullivan LA, Shoptaw EJ, Venator B, Ochoa-Arvelo T, Baxter JR, Manocchia M, Wennberg D. Improving self-care for heart failure for seniors: the impact of video and written education and decision aids. Popul Health Manag. 2012 Feb;15(1):37-45. do — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient utilization of an eRehab portal measured by number of logons and performance of a home exercise program as documented with an exercise log.		6 weeks	No
Other	Patient cost of care per episode	A patient's insurance explanation of benefits will be reviewed for 6 months from completion of the current episode of care to determine patient out of pocket expenses	6 months	No
Other	Total cost of care per episode	Each patient's EOB will be reviewed to determine total cost of care for each episode of care	6 months	No
Primary	Outcome scores for knee (KOOS) and shoulder (DASH)		six weeks	No
Secondary	NRS-11 pain scores		6 weeks	No