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

NCT04359160 | Completed

• 1 other identifier: 2020 0016 J
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Injuries

Keywords

Mobile App; Rotator Cuff; Outpatient surgery; Follow-up

Outcome Measures

Primary Outcomes (1)

• Return rate

  The overall response rate to the questionnaires

  6 weeks postoperative

Secondary Outcomes (3)

• The quality of the responses

  6 weeks postoperative

• Net Promoter Score (NPS)

  6 weeks postoperative

• Overall patient satisfaction

  6 weeks postoperative

Study Arms (2)

Mobile-app follow-up

EXPERIMENTAL

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

Conventional follow-up

ACTIVE COMPARATOR

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

Interventions

Orthense, Orthense, Digikare Inc. Blagnac, France DEVICE

Mobile-app follow-up care, with questions and score

Mobile-app follow-up

Questionnaire OTHER

Paper questionnaire follow-up, with questions and score

Conventional follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Unable to read French

Sponsors & Collaborators

• L'Institut de Recherche en Chirurgie Orthopédique et Sportive: lead

Study Sites (1)

Clinique Jouvenet

Paris, 75016, France

Location

Related Publications (6)

• 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.

  PMID: 29738599 BACKGROUND

• 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.

  PMID: 30560289 BACKGROUND

• 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.

  PMID: 30021075 BACKGROUND

• 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.

  PMID: 29318171 BACKGROUND

• 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.

  PMID: 28329223 BACKGROUND

• Descamps J, Le Hanneur M, Bouche PA, Boukebous B, Duranthon LD, Grimberg J. Do web-based follow-up surveys have a better response rate than traditional paper-based questionnaires following outpatient arthroscopic rotator cuff repair? A randomized controlled trial. Orthop Traumatol Surg Res. 2023 Apr;109(2):103479. doi: 10.1016/j.otsr.2022.103479. Epub 2022 Nov 17.

  PMID: 36403889 DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jean Grimberg, MD

  L'Institut de Recherche en Chirurgie Orthopédique et Sportive

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 24, 2020
• Study Start: May 1, 2020
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)