Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06520085
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-05
Brief Title:
Optimizing Recovery After Reverse Shoulder Arthroplasty With a Personalized Mobile Health Application
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Optimizing Recovery After Reverse Shoulder Arthroplasty With a Personalized Mobile Health Application
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRAPP
Brief 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 11 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
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 11 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None