Shoulder Osteoarthritis
Conditions
Keywords
Reverse Shoulder Arthroplasty, mHealth, Perioperative Care, Rehabilitation
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.
Interventions
OTHERinteractive 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.
Sponsors
VieCuri Medical Centre
St. Anna Ziekenhuis, Geldrop, Netherlands
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative shoulder functioning | bssix weeks, three months and 1 year | Shoulder functioning measured with the Oxford Shoulder Score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder pain | baseline, daily during the first 6 weeks, 3 months and 1 year | Shoulder pain measured using the Numeric Rating Scale |
| Shoulder disability | baseline, six weeks, three months and 1 year | shoulder disability measured using the Disability of the Arm, Shoulder and Hand |
| Range of Motion of the Shoulder | baseline, six weeks, three months and 1 year | Range of Motion of the Shoulder measured with the goniometer |
| Satisfaction with the Application | six weeks, three months and 1 year | Satisfaction with the Application measured with a five-point likert scale |
| Readmission rate | 1 year | Readmission rate related to RSA |
| Complication rate | 1 year | Complication rate related to RSA |
Countries
Netherlands
Outcome results
None listed