ClinicalTrials.gov
ClinicalTrials.gov Menu

Conventional Follow-up Versus Mobile App For Post-Operative ACL Reconstruction Patients

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: NCT02942940
Recruitment Status : Unknown
Verified October 2016 by University of Toronto Orthopaedic Sports Medicine.
Recruitment status was:  Recruiting
First Posted : October 24, 2016
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
University of Toronto Orthopaedic Sports Medicine

Brief Summary:

Background: Telemedicine is increasingly used to overcome distance between patients and physicians. Preliminary studies suggest that mobile app follow-up care for ACL reconstruction patients is feasible, can avert in-person follow-up care, and is cost-effective.

Objective: To avert in-person follow-up through the use of a mobile app in the first six weeks after surgery.

Methods: This will be a single-center, prospective randomized controlled trial

Results: Data to be analyzed from 72 patients.


Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament (ACL) Tear Device: mobile app Other: conventional in-person Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Conventional Follow-up Versus Mobile App Home Monitoring For Post-Operative Anterior Cruciate Ligament (ACL) Reconstruction Patients: A Randomized Controlled Trial
Study Start Date : October 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: mobile app Device: mobile app
The mobile app follow-up group will have no planned in-person follow-up, however these visits will be replaced with surgical site examination via submitted photos, Visual Analogue Scale (VAS), and Quality of Recovery - 9 questionnaire (QoR-9) and limb specific recovery monitoring. All information is submitted with the mobile app (QoC Health Inc, Toronto).

Active Comparator: in-person Other: conventional in-person
Patients in the conventional follow-up group will have a planned clinic follow-up at 2 and 6 weeks post-operatively, which is the schedule currently used by our surgeons. At these scheduled follow-up visits, patients will be asked to complete the VAS to assess pain and the QoR-9 in addition to recovery questions about their operated extremity.




Primary Outcome Measures :
  1. Required physician visits [ Time Frame: 6 weeks post surgery ]
    Total number of physician visits (including specialist, family physician, and ER) related to surgery


Secondary Outcome Measures :
  1. Health care phone calls [ Time Frame: 6 weeks post surgery ]
    Total number of health care telephone calls and emails (including specialist, family physician and ER)


Other Outcome Measures:
  1. Cost of treatment [ Time Frame: through study completion (approximately one year) ]
    cost of treatment related to surgery (i.e. rehabilitation, assistive devices)

  2. Patient satisfaction with post-operative care [ Time Frame: 6 weeks post surgery ]
    patient satisfaction as recorded in the questionnaires (VAS) at 6 weeks post surgery

  3. Patient satisfaction with post-operative care [ Time Frame: 6 weeks post surgery ]
    patient satisfaction as recorded in the questionnaires (QoR-9) at 6 weeks



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing ACL reconstruction at Women's College Hospital (WCH), between the ages of 18-70.
  • Patients must be able to use a mobile device and communicate in English.

Exclusion Criteria:

  • Patients who are smokers, as they carry increased rates of complications.
  • Patients must not:

    • Suffer from chronic pain
    • Be taking narcotic (morphine-like) medication for pain on a regular basis, and
    • Have an allergy to local anesthetics or morphine-like medications

      • Pain scores captured in the VAS and QoR-9 are important for judging post-operative recovery. Pre-existing pain or inability to take narcotics post-operatively would compromise the reliability of these measures.

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): NCT02942940


Locations
Canada, Ontario
Women's College Hospital Recruiting
Toronto, Ontario, Canada, M5S1B1
Contact: James Higgins, MD       jhiggins@qmed.ca   
Contact: Jennie Gillis    6474053848    j.gillis@utosm.com   
Principal Investigator: John Theodoropoulos, MD         
Sponsors and Collaborators
University of Toronto Orthopaedic Sports Medicine

Responsible Party: University of Toronto Orthopaedic Sports Medicine
ClinicalTrials.gov Identifier: NCT02942940     History of Changes
Other Study ID Numbers: MobileApp
First Posted: October 24, 2016    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided