Conventional Follow-up Versus Mobile App For Post-Operative ACL Reconstruction Patients
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|ClinicalTrials.gov Identifier: NCT02942940|
Recruitment Status : Recruiting
First Posted : October 24, 2016
Last Update Posted : October 25, 2016
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|
|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|
|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.
- Required physician visits [ Time Frame: 6 weeks post surgery ]Total number of physician visits (including specialist, family physician, and ER) related to surgery
- 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)
- Cost of treatment [ Time Frame: through study completion (approximately one year) ]cost of treatment related to surgery (i.e. rehabilitation, assistive devices)
- 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
- Patient satisfaction with post-operative care [ Time Frame: 6 weeks post surgery ]patient satisfaction as recorded in the questionnaires (QoR-9) at 6 weeks
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02942940
|Women's College Hospital||Recruiting|
|Toronto, Ontario, Canada, M5S1B1|
|Contact: James Higgins, MD email@example.com|
|Contact: Jennie Gillis 6474053848 firstname.lastname@example.org|
|Principal Investigator: John Theodoropoulos, MD|