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| ID | Type | Description | Link |
|---|---|---|---|
| N22.075 | Other Identifier | METC Maxima Medical Centre, Eindhoven-Veldhoven |
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| Name | Class |
|---|---|
| Anna ziekenhuis | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative shoulder functioning | Shoulder functioning measured with the Oxford Shoulder Score | bssix weeks, three months and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder pain | Shoulder pain measured using the Numeric Rating Scale | 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 |
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Inclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VieCuri Medisch Centrum | Venlo | Limburg | 5912BL | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40616068 | Derived | 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. |
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IPD may be requested through the contact person. Upon reasonable request these may be provided on a case by case basis.
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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.
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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.
| baseline, six weeks, three months and 1 year |
| Range of Motion of the Shoulder | Range of Motion of the Shoulder measured with the goniometer | baseline, six weeks, three months and 1 year |
| Satisfaction with the Application | Satisfaction with the Application measured with a five-point likert scale | six weeks, three months and 1 year |
| Readmission rate | Readmission rate related to RSA | 1 year |
| Complication rate | Complication rate related to RSA | 1 year |