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

Primary Purpose

Rotator Cuff Injuries

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Orthense, Orthense, Digikare Inc. Blagnac, France
Questionnaire
Sponsored by
L'Institut de Recherche en Chirurgie Orthopédique et Sportive
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Rotator Cuff Injuries focused on measuring Mobile App, Rotator Cuff, Outpatient surgery, Follow-up

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinique Jouvenet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mobile-app follow-up

Conventional follow-up

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Return rate
The overall response rate to the questionnaires

Secondary Outcome Measures

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

Full Information

First Posted
April 20, 2020
Last Updated
January 12, 2021
Sponsor
L'Institut de Recherche en Chirurgie Orthopédique et Sportive
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1. Study Identification

Unique Protocol Identification Number
NCT04359160
Brief Title
Comparison of Follow-up by Mobile App or Paper Questionnaire of Patients Undergoing Rotator Cuff Surgery
Acronym
OFUE
Official Title
Comparison of Follow-up by Mobile Application or Paper Questionnaire of Patients Undergoing Rotator Cuff Surgery: Monocentric, Prospective, Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
L'Institut de Recherche en Chirurgie Orthopédique et Sportive

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Injuries
Keywords
Mobile App, Rotator Cuff, Outpatient surgery, Follow-up

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobile-app follow-up
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional follow-up
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Orthense, Orthense, Digikare Inc. Blagnac, France
Intervention Description
Mobile-app follow-up care, with questions and score
Intervention Type
Other
Intervention Name(s)
Questionnaire
Intervention Description
Paper questionnaire follow-up, with questions and score
Primary Outcome Measure Information:
Title
Return rate
Description
The overall response rate to the questionnaires
Time Frame
6 weeks postoperative
Secondary Outcome Measure Information:
Title
The quality of the responses
Description
response rate inside the questionnaire
Time Frame
6 weeks postoperative
Title
Net Promoter Score (NPS)
Description
whether or not the patient recommended the questionnaire used, a scale of 0 (not at all likely) to 10 (very likely)
Time Frame
6 weeks postoperative
Title
Overall patient satisfaction
Description
whether or not the patient is satisfied of the questionnaire used, a scale of 0 (not at all) to 10 (very good)
Time Frame
6 weeks postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Grimberg, MD
Organizational Affiliation
L'Institut de Recherche en Chirurgie Orthopédique et Sportive
Official's Role
Study Director
Facility Information:
Facility Name
Clinique Jouvenet
City
Paris
ZIP/Postal Code
75016
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29738599
Citation
Gil JA, Durand WM, Johnson JP, Goodman AD, Owens BD, Daniels AH. Unanticipated Admission Following Outpatient Rotator Cuff Repair: An Analysis of 18,061 Cases. Orthopedics. 2018 May 1;41(3):164-168. doi: 10.3928/01477447-20180501-04. Epub 2018 May 9.
Results Reference
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PubMed Identifier
30560289
Citation
Calvo E, Torres MD, Morcillo D, Leal V. Rotator cuff repair is more painful than other arthroscopic shoulder procedures. Arch Orthop Trauma Surg. 2019 May;139(5):669-674. doi: 10.1007/s00402-018-3100-0. Epub 2018 Dec 17.
Results Reference
background
PubMed Identifier
30021075
Citation
Kosinski LR, Gil JA, Durand WM, DeFroda SF, Owens BD, Daniels AH. 30-Day readmission following outpatient rotator cuff repair: an analysis of 18,061 cases. Phys Sportsmed. 2018 Nov;46(4):466-470. doi: 10.1080/00913847.2018.1502571. Epub 2018 Jul 27.
Results Reference
background
PubMed Identifier
29318171
Citation
Higgins J, Semple J, Murnaghan L, Sharpe S, Theodoropoulos J. Mobile Web-Based Follow-up for Postoperative ACL Reconstruction: A Single-Center Experience. Orthop J Sports Med. 2017 Dec 22;5(12):2325967117745278. doi: 10.1177/2325967117745278. eCollection 2017 Dec.
Results Reference
background
PubMed Identifier
28329223
Citation
Armstrong KA, Coyte PC, Brown M, Beber B, Semple JL. Effect of Home Monitoring via Mobile App on the Number of In-Person Visits Following Ambulatory Surgery: A Randomized Clinical Trial. JAMA Surg. 2017 Jul 1;152(7):622-627. doi: 10.1001/jamasurg.2017.0111.
Results Reference
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Comparison of Follow-up by Mobile App or Paper Questionnaire of Patients Undergoing Rotator Cuff Surgery

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