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

Conventional Follow-up Versus Mobile App Home Monitoring For Post-Operative Anterior Cruciate Ligament (ACL) Reconstruction Patients: A Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Anterior Cruciate Ligament (ACL) Tear
• Intervention / Treatment: Device: mobile app; Other: conventional in-person

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S1B1
      • Recruiting
      • Women's College Hospital
      • Contact: James Higgins, MD; Email: jhiggins@qmed.ca
      • Contact: Jennie Gillis; Phone Number: 6474053848; Email: j.gillis@utosm.com
      • Principal Investigator: John Theodoropoulos, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Required physician visits	Total number of physician visits (including specialist, family physician, and ER) related to surgery	6 weeks post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health care phone calls	Total number of health care telephone calls and emails (including specialist, family physician and ER)	6 weeks post surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost of treatment	cost of treatment related to surgery (i.e. rehabilitation, assistive devices)	through study completion (approximately one year)
Patient satisfaction with post-operative care	patient satisfaction as recorded in the questionnaires (VAS) at 6 weeks post surgery	6 weeks post surgery
Patient satisfaction with post-operative care	patient satisfaction as recorded in the questionnaires (QoR-9) at 6 weeks	6 weeks post surgery

Collaborators and Investigators

• Sponsor: University of Toronto Orthopaedic Sports Medicine

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: October 6, 2016
• First Submitted That Met QC Criteria: October 20, 2016
• First Posted (Estimate): October 24, 2016

Study Record Updates

• Last Update Posted (Estimate): October 25, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: MobileApp

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED