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

NCT02025400 | Completed Phase 1

• 1 other identifier: eRehab101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

Rehabilitation; eRehab; Physical Therapy; e-Health; Telemedicine; Telerehabilitation; Patient-Centered

Outcome Measures

Primary Outcomes (1)

• Outcome scores for knee (KOOS) and shoulder (DASH)

  six weeks

Secondary Outcomes (1)

• NRS-11 pain scores

  6 weeks

Other Outcomes (3)

• 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

• Patient cost of care per episode

  6 months

• Total cost of care per episode

  6 months

Study Arms (2)

Physical Therapy

ACTIVE COMPARATOR

This arm will receive the standard of care for orthopedic patients receiving a diagnosis and then a recommendation for outpatient physical therapy referral. They will follow through on the referral and attend physical therapy.

Other: Formal Physical Therapy

eRehab

EXPERIMENTAL

This group will not go to formal therapy but receive Internet delivered patient education and exercise instruction. This group will then perform those exercises at home.

Other: eRehab

Interventions

eRehab OTHER

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.

eRehab

Formal Physical Therapy OTHER

This intervention involves referral to a licensed physical therapist or supervised ATC-L.

Physical Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Charlotte Sports Medicine Institute, PA: lead
• Advanced Orthopedic Specialists: collaborator
• The Orthopaedic Center: collaborator

Study Sites (2)

Advanced Orthopaedic Specialists

Prince Frederick, Maryland, 20678, United States

Location

Charlotte Sports Medicine Institute

Charlotte, North Carolina, 28269, United States

Location

Related Publications (24)

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

  BACKGROUND

• 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.

  BACKGROUND

• Antypas K, Wangberg SC. E-Rehabilitation - an Internet and mobile phone based tailored intervention to enhance self-management of cardiovascular disease: study protocol for a randomized controlled trial. BMC Cardiovasc Disord. 2012 Jul 9;12:50. doi: 10.1186/1471-2261-12-50.

  PMID: 22776554 RESULT

• 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 procedures versus a home exercise program. Phys Ther. 2005 Dec;85(12):1301-17.

  PMID: 16305269 RESULT

• APTA Presentation to House Ways and Means Committee, 2011

  RESULT

• Farley FA, Weinstein SL. The case for patient-centered care in orthopaedics. J Am Acad Orthop Surg. 2006 Aug;14(8):447-51. doi: 10.5435/00124635-200608000-00001.

  PMID: 16885475 RESULT

• 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.

  PMID: 23209265 RESULT

• 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: 10.1016/j.apmr.2007.11.058. Epub 2008 Jun 30.

  PMID: 18586222 RESULT

• 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. doi: 10.1177/0363546504273051. Epub 2005 Jul 7.

  PMID: 16002493 RESULT

• 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.

  PMID: 21248209 RESULT

• 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.

  PMID: 10037543 RESULT

• 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. doi: 10.1111/j.1532-5415.2009.02346.x. Epub 2009 Jun 8.

  PMID: 19515102 RESULT

• 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. doi: 10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L.

  PMID: 8773720 RESULT

• 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: cost-effectiveness and patient adherence. Health Technol Assess. 2007 Sep;11(35):1-118. doi: 10.3310/hta11350.

  PMID: 17767899 RESULT

• 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.00964.

  PMID: 24196464 RESULT

• 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.

  PMID: 18835532 RESULT

• 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):289-99. doi: 10.1002/art.1790100503.

  PMID: 9362595 RESULT

• 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 health economic analysis. Health Technol Assess. 2004 Nov;8(46):iii-iv, 1-61. doi: 10.3310/hta8460.

  PMID: 15527668 RESULT

• 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.

  RESULT

• 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. doi: 10.2519/jospt.1998.28.2.88.

  PMID: 9699158 RESULT

• 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.

  PMID: 15123925 RESULT

• 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):262-275. doi: 10.1016/j.ypmed.2012.07.007. Epub 2012 Jul 17.

  PMID: 22813920 RESULT

• 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.

  PMID: 21252603 RESULT

• 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. doi: 10.1089/pop.2011.0019. Epub 2011 Oct 17.

  PMID: 22004181 RESULT

MeSH Terms

Conditions

Knee Injuries; Shoulder Injuries; Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 26, 2013
• First Posted: January 1, 2014
• Study Start: July 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 1, 2014

Record last verified: 2013-12

Locations

US (2)