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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
170
Patients will receive interactive information via an mHealth application tailored to their needs and progress during the rehabilitation period after RSA.
VieCuri Medisch Centrum
Venlo, Limburg, Netherlands
Postoperative shoulder functioning
Shoulder functioning measured with the Oxford Shoulder Score
Time frame: bssix weeks, three months and 1 year
Shoulder pain
Shoulder pain measured using the Numeric Rating Scale
Time frame: 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
Time frame: baseline, six weeks, three months and 1 year
Range of Motion of the Shoulder
Range of Motion of the Shoulder measured with the goniometer
Time frame: baseline, six weeks, three months and 1 year
Satisfaction with the Application
Satisfaction with the Application measured with a five-point likert scale
Time frame: six weeks, three months and 1 year
Readmission rate
Readmission rate related to RSA
Time frame: 1 year
Complication rate
Complication rate related to RSA
Time frame: 1 year
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