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
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
|Women's College Hospital||Recruiting|
|Toronto, Ontario, Canada, M5S1B1|
|Contact: James Higgins, MD firstname.lastname@example.org|
|Contact: Jennie Gillis 6474053848 email@example.com|
|Principal Investigator: John Theodoropoulos, MD|