Comparison of Follow-up by Mobile App or Paper Questionnaire of Patients Undergoing Rotator Cuff Surgery

Not Applicable

Completed

• Conditions: Rotator Cuff Injuries
• Interventions: Device: Orthense, Orthense, Digikare Inc. Blagnac, France; Other: Questionnaire

• Registration Number: NCT04359160
• Lead Sponsor: L'Institut de Recherche en Chirurgie Orthopédique et Sportive

Brief Summary

This study evaluate if in an outpatient rotator cuff surgery, can the use of mobile app compared to conventional paper questionnaire improve follow-up care in the first 90-days following surgery.

Detailed Description

Rotator cuff surgery is a painful arthroscopic surgery. In outpatient surgery, the surgeons have to increase the security and surveillance after the surgery to reassure the patient and avoid complications.

Most patients receiving ambulatory rotator cuff surgery have high pain score, and management and aspects of the rehabilitation can be challenging. However, regular follow-up is still considered important in the early post-operative phase. In between the conventional appointment 6 weeks post op and 12 weeks post op, the surgeons have no status of the patient, and no markers to check if the postoperative care is evolving right.

Currently, the investigators are using a mobile application (Orthense by Digikare, Blagnac, France) to complement in-person postoperative follow-up care for patients.

Study Timeline

• Study First Submitted: 2020-04-20
• Study First Submitted QC: 2020-04-22
• Study First Posted: 2020-04-24
• Study Start: 2020-05-01
• Primary Completion: 2020-11-30
• Study Completion: 2020-11-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-12
• Last Update Posted: 2021-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• Patients undergoing rotator cuff surgery. They must be able to use a mobile-app, and have an email address and internet connexion.

Exclusion Criteria

• Unable to read French

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mobile-app follow-up	Orthense, Orthense, Digikare Inc. Blagnac, France	The mobile app follow-up group will receive an email, to connect into a secure website. They will answer to periodical questions about their condition. They will have a medical appointment at 6 weeks postoperative and 12 weeks postoperative. All of this information is submitted via the mobile application (Orthense, Digikare Inc. Blagnac, France).The surgeon will have an access to the answer of the patient in real time, and if the patient didn't answer.
Conventional follow-up	Questionnaire	Patients in the conventional, questionnaire follow-up group will have the same periodical questions but on paper. They will have to stick personally with the schedule without any reminders. They will have a medical appointment at 6 weeks postoperative and 12 weeks postoperative where they have to bring the questionnaire.

Primary Outcome Measures

Name	Time	Method
Return rate	6 weeks postoperative	The overall response rate to the questionnaires

Secondary Outcome Measures

Name	Time	Method
Overall patient satisfaction	6 weeks postoperative	whether or not the patient is satisfied of the questionnaire used, a scale of 0 (not at all) to 10 (very good)
The quality of the responses	6 weeks postoperative	response rate inside the questionnaire
Net Promoter Score (NPS)	6 weeks postoperative	whether or not the patient recommended the questionnaire used, a scale of 0 (not at all likely) to 10 (very likely)

Trial Locations

Locations (1)

Clinique Jouvenet; 🇫🇷 Paris, France