Optimizing Recovery After Reverse Shoulder Arthroplasty With a Personalized Mobile Health Application
- Conditions
- Shoulder Osteoarthritis
- Interventions
- Other: interactive mHealth application for patients undergoing RSA
- Registration Number
- NCT06520085
- Lead Sponsor
- VieCuri Medical Centre
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 170
- adults undergoing elective reverse shoulder arthroplasty
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard care interactive mHealth application for patients undergoing RSA The control group will receive postoperative information and a rehabilitation program via the non-interactive application, which is current standard care Personalized rehabilitation program interactive mHealth application for patients undergoing RSA 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.
- Primary Outcome Measures
Name Time Method Postoperative shoulder functioning bssix weeks, three months and 1 year Shoulder functioning measured with the Oxford Shoulder Score
- Secondary Outcome Measures
Name Time Method Range of Motion of the Shoulder baseline, six weeks, three months and 1 year Range of Motion of the Shoulder measured with the goniometer
Shoulder disability baseline, six weeks, three months and 1 year shoulder disability measured using the Disability of the Arm, Shoulder and Hand
Readmission rate 1 year Readmission rate related to RSA
Complication rate 1 year Complication rate related to RSA
Shoulder pain baseline, daily during the first 6 weeks, 3 months and 1 year Shoulder pain measured using the Numeric Rating Scale
Satisfaction with the Application six weeks, three months and 1 year Satisfaction with the Application measured with a five-point likert scale
Trial Locations
- Locations (1)
VieCuri Medisch Centrum
🇳🇱Venlo, Limburg, Netherlands