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

December 31, 2013 updated by: Jonathan Paul, MD, Charlotte Sports Medicine Institute, PA

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Prince Frederick, Maryland, United States, 20678
        • Advanced Orthopaedic Specialists
    • North Carolina
      • Charlotte, North Carolina, United States, 28269
        • Charlotte Sports Medicine Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Outcome scores for knee (KOOS) and shoulder (DASH)
Time Frame: six weeks
six weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
NRS-11 pain scores
Time Frame: 6 weeks
6 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charlotte Sports Medicine Institute, PA

Collaborators

Advanced Orthopedic Specialists
The Orthopaedic Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

December 26, 2013

First Submitted That Met QC Criteria

December 31, 2013

First Posted (Estimate)

January 1, 2014

Study Record Updates

Last Update Posted (Estimate)

January 1, 2014

Last Update Submitted That Met QC Criteria

December 31, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • eRehab101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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