Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540430
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Digital Based Home Care Service for Ostomy Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Digital Based Home Care Service for Ostomy Patients Randomized Controlled Trials
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
This study aims to enhance the physical psychological and social aspects of stoma care by providing a self-management service via a smartphone application and to evaluate the impact of this digital-based application on patients quality of life
Detailed Description:
This study will include patients who have undergone colorectal cancer surgery and received either a colostomy or ileostomy provided they are comfortable using digital devices like smartphones Patients will be randomly assigned to either the intervention group receiving stoma care through a smartphone application or the conventional group receiving standard outpatient-based care The intervention group will use a mobile application where patients input their stoma condition allowing healthcare professionals to monitor and manage their care The app provides patients with information on diet physical activity stoma care emotional support and daily living needs Both groups will be assessed for outcomes at the time of enrollment and at 1 and 6 months Outcome measures include stoma-related complications such as peristomal dermatitis dehydration acute renal failure readmission due to stoma-related issues and quality of life and emotional state assessments using EQ-5D-5L and Stoma Quality of Life questionnaires
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