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

NCT02942940 | Unknown

• 1 other identifier: MobileApp
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament (ACL) Tear

Outcome Measures

Primary Outcomes (1)

• Required physician visits

  Total number of physician visits (including specialist, family physician, and ER) related to surgery

  6 weeks post surgery

Secondary Outcomes (1)

• Health care phone calls

  6 weeks post surgery

Other Outcomes (3)

• Cost of treatment

  through study completion (approximately one year)

• Patient satisfaction with post-operative care

  6 weeks post surgery

• Patient satisfaction with post-operative care

  6 weeks post surgery

Study Arms (2)

mobile app

ACTIVE COMPARATOR

Device: mobile app

in-person

ACTIVE COMPARATOR

Other: conventional in-person

Interventions

mobile app DEVICE

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).

mobile app

conventional in-person OTHER

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.

in-person

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Toronto Orthopaedic Sports Medicine: lead

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S1B1, Canada

RECRUITING

MeSH Terms

Conditions

Lacerations

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: October 24, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: April 1, 2018
• Last Updated: October 25, 2016

Record last verified: 2016-10

Locations

CA (1)