Internet Enhanced, Patient-Centered Orthopedic Care: A Prospective, Randomized, Controlled Pilot Trial
Primary Purpose
Knee Injuries, Shoulder Injuries, Rotator Cuff Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
eRehab
Formal Physical Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Knee Injuries focused on measuring Rehabilitation, eRehab, Physical Therapy, e-Health, Telemedicine, Telerehabilitation, Patient-Centered
Eligibility Criteria
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
Sites / Locations
- Advanced Orthopaedic Specialists
- Charlotte Sports Medicine Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Physical Therapy
eRehab
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Outcome scores for knee (KOOS) and shoulder (DASH)
Secondary Outcome Measures
NRS-11 pain scores
Full Information
NCT ID
NCT02025400
First Posted
December 26, 2013
Last Updated
December 31, 2013
Sponsor
Charlotte Sports Medicine Institute, PA
Collaborators
Advanced Orthopedic Specialists, The Orthopaedic Center
1. Study Identification
Unique Protocol Identification Number
NCT02025400
Brief Title
Internet Enhanced, Patient-Centered Orthopedic Care: A Prospective, Randomized, Controlled Pilot Trial
Official Title
Phase I Study Comparing Internet Delivered Home Exercise Programs to Standard Orthopedic Care and Outpatient Physical Therapy.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charlotte Sports Medicine Institute, PA
Collaborators
Advanced Orthopedic Specialists, The Orthopaedic Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries, Shoulder Injuries, Rotator Cuff Disease, Meniscus Tear, Patellofemoral Pain
Keywords
Rehabilitation, eRehab, Physical Therapy, e-Health, Telemedicine, Telerehabilitation, Patient-Centered
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physical Therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
eRehab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
eRehab
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Formal Physical Therapy
Intervention Description
This intervention involves referral to a licensed physical therapist or supervised ATC-L.
Primary Outcome Measure Information:
Title
Outcome scores for knee (KOOS) and shoulder (DASH)
Time Frame
six weeks
Secondary Outcome Measure Information:
Title
NRS-11 pain scores
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Patient utilization of an eRehab portal measured by number of logons and performance of a home exercise program as documented with an exercise log.
Time Frame
6 weeks
Title
Patient cost of care per episode
Description
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
Time Frame
6 months
Title
Total cost of care per episode
Description
Each patient's EOB will be reviewed to determine total cost of care for each episode of care
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Advanced Orthopaedic Specialists
City
Prince Frederick
State/Province
Maryland
ZIP/Postal Code
20678
Country
United States
Facility Name
Charlotte Sports Medicine Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28269
Country
United States
12. IPD Sharing Statement
Citations:
Citation
Burden of Musculoskeletal Diseases in the United States: Prevalence, Societal and Economic Cost. Rosemont, IL, American Academy of Orthopaedic Surgeons. February 2008.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
22776554
Citation
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.
Results Reference
result
PubMed Identifier
16305269
Citation
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.
Results Reference
result
Citation
APTA Presentation to House Ways and Means Committee, 2011
Results Reference
result
PubMed Identifier
16885475
Citation
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.
Results Reference
result
PubMed Identifier
23209265
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.
Results Reference
result
PubMed Identifier
18586222
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: 10.1016/j.apmr.2007.11.058. Epub 2008 Jun 30.
Results Reference
result
PubMed Identifier
16002493
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. doi: 10.1177/0363546504273051. Epub 2005 Jul 7.
Results Reference
result
PubMed Identifier
21248209
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.
Results Reference
result
PubMed Identifier
10037543
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.
Results Reference
result
PubMed Identifier
19515102
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. doi: 10.1111/j.1532-5415.2009.02346.x. Epub 2009 Jun 8.
Results Reference
result
PubMed Identifier
8773720
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. doi: 10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L. Erratum In: Am J Ind Med 1996 Sep;30(3):372.
Results Reference
result
PubMed Identifier
17767899
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: cost-effectiveness and patient adherence. Health Technol Assess. 2007 Sep;11(35):1-118. doi: 10.3310/hta11350.
Results Reference
result
PubMed Identifier
24196464
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.00964.
Results Reference
result
PubMed Identifier
18835532
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.
Results Reference
result
PubMed Identifier
9362595
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):289-99. doi: 10.1002/art.1790100503.
Results Reference
result
PubMed Identifier
15527668
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 health economic analysis. Health Technol Assess. 2004 Nov;8(46):iii-iv, 1-61. doi: 10.3310/hta8460.
Results Reference
result
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.
Results Reference
result
PubMed Identifier
9699158
Citation
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.
Results Reference
result
PubMed Identifier
15123925
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.
Results Reference
result
PubMed Identifier
22813920
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):262-275. doi: 10.1016/j.ypmed.2012.07.007. Epub 2012 Jul 17.
Results Reference
result
PubMed Identifier
21252603
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.
Results Reference
result
PubMed Identifier
22004181
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. doi: 10.1089/pop.2011.0019. Epub 2011 Oct 17.
Results Reference
result
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Internet Enhanced, Patient-Centered Orthopedic Care: A Prospective, Randomized, Controlled Pilot Trial
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