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

NCT ID: NCT02942940

Last Updated: 2016-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Anterior Cruciate Ligament (ACL) Tear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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mobile app

Group Type ACTIVE_COMPARATOR

mobile app

Intervention Type 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).

in-person

Group Type ACTIVE_COMPARATOR

conventional in-person

Intervention Type 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.

Interventions

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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).

Intervention Type DEVICE

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Toronto Orthopaedic Sports Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Women's College Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Facility Contacts

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James Higgins, MD

Role: primary

Jennie Gillis

Role: backup

Other Identifiers

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MobileApp

Identifier Type: -

Identifier Source: org_study_id