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

Обзор

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.

Вмешательства

• Другое interactive 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.

Первичные конечные точки

• Postoperative shoulder functioning [Срок оценки: bssix weeks, three months and 1 year]

Вторичные конечные точки (6)

• Shoulder pain [Срок оценки: baseline, daily during the first 6 weeks, 3 months and 1 year]
• Shoulder disability [Срок оценки: baseline, six weeks, three months and 1 year]
• Range of Motion of the Shoulder [Срок оценки: baseline, six weeks, three months and 1 year]
• Satisfaction with the Application [Срок оценки: six weeks, three months and 1 year]
• Readmission rate [Срок оценки: 1 year]
• Complication rate [Срок оценки: 1 year]

Критерии участия

Критерии включения

• adults undergoing elective reverse shoulder arthroplasty

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• VieCuri Medisch Centrum — Venlo

Публикации

• Crutsen JRW, Heerspink FOL, Kornuijt A, Ascencio J, van der Weegen W, Timmers T, Craamer C, van Raay JJAM, Hollman F, Janssen ERC. Optimizing recovery after reverse shoulder arthroplasty with a personalised mobile health application compared to generic digital information: a protocol of a multicentre randomised controlled trial. BMC Musculoskelet Disord. 2025 Jul 4;26(1):642. doi: 10.1186/s12891-0 PMID 40616068

Идентификаторы

NCT: NCT06520085 · TRAPP · N22.075

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗