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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

At Home, Digital Rehabilitation for Patients After Reverse Total Shoulder Arthroplasty

NCT06891378

Arthroplasty, Replacement, Shoulder Reverse Total Shoulder Arthroplasty

RECRUITING NA

Reverse Shoulder Replacement: Age 60 or Younger Outcomes

NCT03148184

Shoulder Arthritis

COMPLETED

Ntelligently Integrated Digital Rehabilitation Model Combining mHealth and ERAS in Total Hip and Knee Arthroplasty

NCT07199478

Total Knee Arthroplasty Total Hip Arthroplasty ERAS

ACTIVE_NOT_RECRUITING NA

Arthroplasty Rehabilitation Score - Can we Predict the Short Term Postoperative Outcome?

NCT00668915

Osteoarthritis

UNKNOWN

Patient Reported Outcome Measures (PROMs) in Rehabilitation With or Without the Possible Use of a Mobile Application After Primary Knee or Hip Arthroplasty

NCT04628468

Arthroplasty, Replacement, Knee Rehabilitation Hip Arthrosis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Shoulder Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

interactive mHealth application for patients undergoing RSA

Intervention Type OTHER

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

Standard care

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

Group Type ACTIVE_COMPARATOR

interactive mHealth application for patients undergoing RSA

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No