VieCuri Medisch Centrum
Venlo, Limburg, 5912BL, Netherlands
NCT Number: NCT06520085
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Venlo, Limburg, 5912BL, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive interactive information via an mHealth application tailored to their needs and progress during the rehabilitation period after RSA.
Time frame: bssix weeks, three months and 1 year
Shoulder functioning measured with the Oxford Shoulder Score
Time frame: baseline, daily during the first 6 weeks, 3 months and 1 year
Shoulder pain measured using the Numeric Rating Scale
Time frame: baseline, six weeks, three months and 1 year
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 measured with the goniometer
Time frame: six weeks, three months and 1 year
Satisfaction with the Application measured with a five-point likert scale
Time frame: 1 year
Readmission rate related to RSA
Time frame: 1 year
Complication rate related to RSA
VieCuri Medical Centre
Other
Acronym: TRAPP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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