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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02025400
Recruitment Status : Completed
First Posted : January 1, 2014
Last Update Posted : January 1, 2014
Sponsor:
Collaborators:
Advanced Orthopedic Specialists
The Orthopaedic Center
Information provided by (Responsible Party):
Jonathan Paul, MD, Charlotte Sports Medicine Institute, PA

Study Description
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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.

Condition or disease Intervention/treatment Phase
Knee Injuries Shoulder Injuries Rotator Cuff Disease Meniscus Tear Patellofemoral Pain Other: eRehab Other: Formal Physical Therapy Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study Comparing Internet Delivered Home Exercise Programs to Standard Orthopedic Care and Outpatient Physical Therapy.
Study Start Date : July 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Physical Therapy
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
This intervention involves referral to a licensed physical therapist or supervised ATC-L.
Experimental: eRehab
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. Outcome scores for knee (KOOS) and shoulder (DASH) [ Time Frame: six weeks ]

Secondary Outcome Measures :
  1. NRS-11 pain scores [ Time Frame: 6 weeks ]

Other Outcome Measures:
  1. 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 ]
  2. Patient cost of care per episode [ Time Frame: 6 months ]
    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

  3. Total cost of care per episode [ Time Frame: 6 months ]
    Each patient's EOB will be reviewed to determine total cost of care for each episode of care


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02025400


Locations
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United States, Maryland
Advanced Orthopaedic Specialists
Prince Frederick, Maryland, United States, 20678
United States, North Carolina
Charlotte Sports Medicine Institute
Charlotte, North Carolina, United States, 28269
Sponsors and Collaborators
Charlotte Sports Medicine Institute, PA
Advanced Orthopedic Specialists
The Orthopaedic Center
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:
APTA Presentation to House Ways and Means Committee, 2011
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.

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

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Responsible Party: Jonathan Paul, MD, Director, Charlotte Sports Medicine Institute, PA
ClinicalTrials.gov Identifier: NCT02025400    
Other Study ID Numbers: eRehab101
First Posted: January 1, 2014    Key Record Dates
Last Update Posted: January 1, 2014
Last Verified: December 2013
Keywords provided by Jonathan Paul, MD, Charlotte Sports Medicine Institute, PA:
Rehabilitation
eRehab
Physical Therapy
e-Health
 Telemedicine
Telerehabilitation
Patient-Centered
Additional relevant MeSH terms:
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Wounds and Injuries
Knee Injuries
Shoulder Injuries
Leg Injuries