Clinical trial NCT06520085: Optimizing Recovery After Reverse Shoulder Arthroplasty With a Personalized Mobile Health Application
Official title: Optimizing Recovery After Reverse Shoulder Arthroplasty With a Personalized Mobile Health Application
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Shoulder Osteoarthritis
Keywords: Reverse Shoulder Arthroplasty
mHealth
Perioperative Care
Rehabilitation
Lead sponsor: VieCuri Medical Centre
Sponsor class: OTHER
Collaborators: name: Anna ziekenhuis
First posted: 2024-07-25
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative shoulder functioning
timeFrame: bssix weeks, three months and 1 year
Secondary outcomes:
measure: Shoulder pain
timeFrame: baseline, daily during the first 6 weeks, 3 months and 1 year
measure: Shoulder disability
timeFrame: baseline, six weeks, three months and 1 year
measure: Range of Motion of the Shoulder
timeFrame: baseline, six weeks, three months and 1 year
measure: Satisfaction with the Application
timeFrame: six weeks, three months and 1 year
measure: Readmission rate
timeFrame: 1 year
measure: Complication rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Venlo
country: Netherlands
facility: VieCuri Medisch Centrum
state: Limburg
Study officials:
References: