An interventional study of interactive mHealth application for patients undergoing RSA in Shoulder Osteoarthritis, sponsored by VieCuri Medical Centre. Recruiting at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by VieCuri Medical Centre · Not applicable, Interventional, and Treatment
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.
VieCuri Medical Centre is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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
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.
Postoperative shoulder functioning
Shoulder functioning measured with the Oxford Shoulder Score
Time frame: bssix weeks, three months and 1 year
Shoulder pain
Shoulder pain measured using the Numeric Rating Scale
Time frame: 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
Time frame: baseline, six weeks, three months and 1 year
Range of Motion of the Shoulder
Range of Motion of the Shoulder measured with the goniometer
Time frame: baseline, six weeks, three months and 1 year
Satisfaction with the Application
Satisfaction with the Application measured with a five-point likert scale
Time frame: six weeks, three months and 1 year
Readmission rate
Readmission rate related to RSA
Time frame: 1 year
Complication rate
Complication rate related to RSA
Time frame: 1 year
Plan to share: No — IPD may be requested through the contact person. Upon reasonable request these may be provided on a case by case basis.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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VieCuri Medical Centre