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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

Tracking Information
First Submitted Date  ICMJE December 26, 2013
First Posted Date  ICMJE January 1, 2014
Last Update Posted Date January 1, 2014
Study Start Date  ICMJE July 2012
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 31, 2013)
Outcome scores for knee (KOOS) and shoulder (DASH) [ Time Frame: six weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 31, 2013)
NRS-11 pain scores [ Time Frame: 6 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 31, 2013)
  • 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 ]
  • 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
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Internet Enhanced, Patient-Centered Orthopedic Care: A Prospective, Randomized, Controlled Pilot Trial
Official Title  ICMJE Phase I Study Comparing Internet Delivered Home Exercise Programs to Standard Orthopedic Care and Outpatient Physical Therapy.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Knee Injuries
  • Shoulder Injuries
  • Rotator Cuff Disease
  • Meniscus Tear
  • Patellofemoral Pain
Intervention  ICMJE
  • 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.
  • Other: Formal Physical Therapy
    This intervention involves referral to a licensed physical therapist or supervised ATC-L.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Formal Physical Therapy
  • 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.
    Intervention: Other: eRehab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 31, 2013)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02025400
Other Study ID Numbers  ICMJE eRehab101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jonathan Paul, MD, Charlotte Sports Medicine Institute, PA
Study Sponsor  ICMJE Charlotte Sports Medicine Institute, PA
Collaborators  ICMJE
  • Advanced Orthopedic Specialists
  • The Orthopaedic Center
Investigators  ICMJE Not Provided
PRS Account Charlotte Sports Medicine Institute, PA
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP