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NCT Number: NCT06520085

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adults undergoing elective reverse shoulder arthroplasty

Exclusion criteria

  • 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.

Treatment and study plan

interactive mHealth application for patients undergoing RSA

Other

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

Primary outcomes

  1. Postoperative shoulder functioning

    Time frame: bssix weeks, three months and 1 year

    Shoulder functioning measured with the Oxford Shoulder Score

Secondary outcomes

  1. Shoulder pain

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

    Shoulder pain measured using the Numeric Rating Scale

  2. Shoulder disability

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

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

  3. Range of Motion of the Shoulder

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

    Range of Motion of the Shoulder measured with the goniometer

  4. Satisfaction with the Application

    Time frame: six weeks, three months and 1 year

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

  5. Readmission rate

    Time frame: 1 year

    Readmission rate related to RSA

  6. Complication rate

    Time frame: 1 year

    Complication rate related to RSA

Sponsors and collaborators

Lead sponsor

VieCuri Medical Centre

Other

Collaborators

  • Anna ziekenhuis

Registry information

Acronym: TRAPP

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 25, 2024
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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