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

Sponsor
L'Institut de Recherche en Chirurgie Orthopédique et Sportive (Other)
Overall Status
Completed
CT.gov ID
NCT04359160
Collaborator
(none)
59
1
2
7
8.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Orthense, Orthense, Digikare Inc. Blagnac, France
  • Other: Questionnaire
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
59 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Comparison of Follow-up by Mobile Application or Paper Questionnaire of Patients Undergoing Rotator Cuff Surgery: Monocentric, Prospective, Randomized Study
Actual Study Start Date :
May 1, 2020
Actual Primary Completion Date :
Nov 30, 2020
Actual Study Completion Date :
Nov 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mobile-app follow-up

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.

Device: Orthense, Orthense, Digikare Inc. Blagnac, France
Mobile-app follow-up care, with questions and score

Active Comparator: Conventional follow-up

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.

Other: Questionnaire
Paper questionnaire follow-up, with questions and score

Outcome Measures

Primary Outcome Measures

  1. Return rate [6 weeks postoperative]

    The overall response rate to the questionnaires

Secondary Outcome Measures

  1. The quality of the responses [6 weeks postoperative]

    response rate inside the questionnaire

  2. 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)

  3. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinique Jouvenet Paris France 75016

Sponsors and Collaborators

  • L'Institut de Recherche en Chirurgie Orthopédique et Sportive

Investigators

  • Study Director: Jean Grimberg, MD, L'Institut de Recherche en Chirurgie Orthopédique et Sportive

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
L'Institut de Recherche en Chirurgie Orthopédique et Sportive
ClinicalTrials.gov Identifier:
NCT04359160
Other Study ID Numbers:
  • 2020 0016 J
First Posted:
Apr 24, 2020
Last Update Posted:
Jan 14, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by L'Institut de Recherche en Chirurgie Orthopédique et Sportive
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 14, 2021