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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• adults undergoing elective reverse shoulder arthroplasty

Locations
Other Locations
Netherlands
Anna ziekenhuis
RECRUITING
Geldrop
VieCuri Medisch Centrum
RECRUITING
Venlo
Time Frame
Start Date: 2024-09-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 170
Treatments
Experimental: Personalized rehabilitation program
The intervention group receives an interactive app that is different from the control is different from the control group in that it provides interactive and personalized information and a personalized rehabilitation program. Both the timing and the amount and nature of the exercises are personalized.
Active_comparator: Standard care
The control group will receive postoperative information and a rehabilitation program via the non-interactive application, which is current standard care
Related Therapeutic Areas
Sponsors
Leads: VieCuri Medical Centre
Collaborators: St. Anna Ziekenhuis, Geldrop, Netherlands

This content was sourced from clinicaltrials.gov