Health TrialsbyHealthPanel

Optimizing Recovery After Reverse Shoulder Arthroplasty With a Personalized Mobile Health Application

ConditionShoulder Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVieCuri Medical Centre

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

adults undergoing elective reverse shoulder arthroplasty

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • interactive mHealth application for patients undergoing RSA

    Other intervention

    Patients will receive interactive information via an mHealth application tailored to their needs and progress during the rehabilitation period after RSA.

Treatment groups

170 Participants
are divided into 2 treatment groups
Group A: Personalized rehabilitation programExperimental treatment 1 intervention
Group B: Standard careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative shoulder functioning

Shoulder functioning measured with the Oxford Shoulder Score

Time frame
bssix weeks, three months and 1 year

Secondary outcomes

1

Shoulder pain

Shoulder pain measured using the Numeric Rating Scale

Time frame
baseline, daily during the first 6 weeks, 3 months and 1 year
2

Shoulder disability

shoulder disability measured using the Disability of the Arm, Shoulder and Hand

Time frame
baseline, six weeks, three months and 1 year
3

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
4

Satisfaction with the Application

Satisfaction with the Application measured with a five-point likert scale

Time frame
six weeks, three months and 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VieCuri Medical Centre

Lead sponsor

St. Anna Ziekenhuis, Geldrop, Netherlands

Collaborator

Source ClinicalTrials.gov
Apply now