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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Postoperative shoulder functioning [Time frame: bssix weeks, three months and 1 year]

Secondary outcome measures (6)

• Shoulder pain [Time frame: baseline, daily during the first 6 weeks, 3 months and 1 year]
• Shoulder disability [Time frame: baseline, six weeks, three months and 1 year]
• Range of Motion of the Shoulder [Time frame: baseline, six weeks, three months and 1 year]
• Satisfaction with the Application [Time frame: six weeks, three months and 1 year]
• Readmission rate [Time frame: 1 year]
• Complication rate [Time frame: 1 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Netherlands · 1 center

• VieCuri Medisch Centrum — Venlo

Publications

• Crutsen JRW, Heerspink FOL, Kornuijt A, Ascencio J, van der Weegen W, Timmers T, Craamer C, van Raay JJAM, Hollman F, Janssen ERC. Optimizing recovery after reverse shoulder arthroplasty with a personalised mobile health application compared to generic digital information: a protocol of a multicentre randomised controlled trial. BMC Musculoskelet Disord. 2025 Jul 4;26(1):642. doi: 10.1186/s12891-0 PMID 40616068

Identifiers

NCT: NCT06520085 · TRAPP · N22.075

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗