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

VieCuri Medical Centre

Status: Not yet enrolling

Conditions: Shoulder Osteoarthritis

Treatments: Other: interactive mHealth application for patients undergoing RSA

Study type: Interventional

Funder types: Other

Identifiers

NCT06520085

TRAPP

N22.075 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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170 participants in 2 patient groups

Personalized rehabilitation program

Experimental group

Description:

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.

Treatment:

Other: interactive mHealth application for patients undergoing RSA

Standard care

Active Comparator group

Description:

The control group will receive postoperative information and a rehabilitation program via the non-interactive application, which is current standard care

Treatment:

Other: interactive mHealth application for patients undergoing RSA