Optimizing Recovery After Reverse Shoulder Arthroplasty With a Personalized Mobile Health Application (TRAPP)

Background: Mobile health (mHealth) - the use of medical applications in healthcare settings - include tools that can support self-management after surgery and thereby contribute to early postoperative recovery. Providing patients with timely and interactive information through mHealth is hypothesized to positively influence recovery after reverse shoulder arthroplasty (RSA).

Aim: The aim of this study is to determine the effectiveness of interactive and personalized information and rehabilitation protocol with a mobile application compared to generic information and generic rehabilitation protocol (standard care) on postoperative recovery in patients undergoing primary RSA.

Methods and analysis: A multicentre randomised controlled trial will be conducted in two Dutch hospitals. In total 170 patients undergoing elective, primary RSA will be included. Participants will be randomly allocated to one of the two groups on a 1:1 ratio. The intervention group will receive interactive postoperative information on a daily basis. The control group will receive standard care. The primary outcome is defined as functional recovery measured using the Oxford Shoulder Score (OSS) at 6 weeks. Secondary outcomes are: pain, physical functioning, quality of life, length of stay, complications, treatment satisfaction and app use. The between group difference will be analysed using linear mixed-effects regression.

Study Overview

• Status: Not yet recruiting
• Conditions: Shoulder Osteoarthritis
• Intervention / Treatment: Other: interactive mHealth application for patients undergoing RSA

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Venlo, Limburg, Netherlands, 5912BL
      • VieCuri Medisch Centrum
      • Contact: Esther Janssen, PhD; Email: estherjanssen@viecuri.nl
      • Contact: Janneke Crutsen, MSc; Email: jcrutsen@viecuri.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• adults undergoing elective reverse shoulder arthroplasty

Exclusion Criteria:

1) do not own or are not able to operate a smart device; 2) are scheduled for revision surgery; 3) have a fracture as primary diagnosis; 4) an additional muscle transfer needs to be performed; or 5) are unable to read and understand the Dutch language.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personalized rehabilitation program; The intervention group receives an interactive app that is different from the control is different from the control group in that it provides interactive and personalized information and a personalized rehabilitation program. Both the timing and the amount and nature of the exercises are personalized.	Other: interactive mHealth application for patients undergoing RSA; Patients will receive interactive information via an mHealth application tailored to their needs and progress during the rehabilitation period after RSA.
Active Comparator: Standard care; The control group will receive postoperative information and a rehabilitation program via the non-interactive application, which is current standard care	Other: interactive mHealth application for patients undergoing RSA; Patients will receive interactive information via an mHealth application tailored to their needs and progress during the rehabilitation period after RSA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative shoulder functioning	Shoulder functioning measured with the Oxford Shoulder Score	bssix weeks, three months and 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder pain	Shoulder pain measured using the Numeric Rating Scale	baseline, daily during the first 6 weeks, 3 months and 1 year
Shoulder disability	shoulder disability measured using the Disability of the Arm, Shoulder and Hand	baseline, six weeks, three months and 1 year
Range of Motion of the Shoulder	Range of Motion of the Shoulder measured with the goniometer	baseline, six weeks, three months and 1 year
Satisfaction with the Application	Satisfaction with the Application measured with a five-point likert scale	six weeks, three months and 1 year
Readmission rate	Readmission rate related to RSA	1 year
Complication rate	Complication rate related to RSA	1 year

Collaborators and Investigators

• Sponsor: VieCuri Medical Centre
• Collaborators: Anna ziekenhuis

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 5, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): July 25, 2024
• Last Update Submitted That Met QC Criteria: July 22, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Rehabilitation; Perioperative Care; mHealth; Reverse Shoulder Arthroplasty
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: TRAPP; N22.075 (Other Identifier: METC Maxima Medical Centre, Eindhoven-Veldhoven)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD may be requested through the contact person. Upon reasonable request these may be provided on a case by case basis.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No