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

NCT06520085 | Not Yet Recruiting

• 2 other identifiers: TRAPPN22.075
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Shoulder Osteoarthritis

Keywords

Reverse Shoulder Arthroplasty; mHealth; Perioperative Care; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Postoperative shoulder functioning

  Shoulder functioning measured with the Oxford Shoulder Score

  bssix weeks, three months and 1 year

Secondary Outcomes (6)

• Shoulder pain

  baseline, daily during the first 6 weeks, 3 months and 1 year

• Shoulder disability

  baseline, six weeks, three months and 1 year

• Range of Motion of the Shoulder

  baseline, six weeks, three months and 1 year

• Satisfaction with the Application

  six weeks, three months and 1 year

• Readmission rate

  1 year

Study Arms (2)

Personalized rehabilitation program

EXPERIMENTAL

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

Standard care

ACTIVE COMPARATOR

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

Interventions

interactive mHealth application for patients undergoing RSA OTHER

Patients will receive interactive information via an mHealth application tailored to their needs and progress during the rehabilitation period after RSA.

Personalized rehabilitation program; Standard care

Eligibility Criteria

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

You may qualify if:

• adults undergoing elective reverse shoulder arthroplasty

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• VieCuri Medical Centre: lead
• Anna ziekenhuis: collaborator

Study Sites (1)

VieCuri Medisch Centrum

Venlo, Limburg, 5912BL, Netherlands

Location

Related Publications (1)

• 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/s12891-025-08857-9.

  PMID: 40616068 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Because the application relies on interaction between patient and clinical care team, both the patient and clinicians cannot be blinded. The researcher that will perform data analysis will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a multicentre, single-blinded (assessor), two-armed, parallel-group RCT designed to evaluate the effectiveness of a an interactive mHealth application to standard care (non-interactive app) in the rehabilitation period of patients undergoing RSA.

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 25, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)