Digital Based Home Care Service for Ostomy Patients
1 other identifier
interventional
120
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2024
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2024
CompletedFirst Posted
Study publicly available on registry
August 6, 2024
CompletedStudy Start
First participant enrolled
September 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2026
CompletedAugust 9, 2024
August 1, 2024
12 months
July 29, 2024
August 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Peristomal Dermatitis
Evaluated using the DET Score (Discoloration, Erosion, and Tissue Overgrowth) on a scale ranging from 0 to 3.
enrollment, 1 month, and 6 months.
Wound Infection, stoma retraction, bleeding, hernia, and Acute kidney injury
Incidence rate as a percentage of patients affected.
enrollment, 1 month, and 6 months.
Readmission Rate
Incidence rate as the percentage of patients readmitted due to stoma-related complications.
enrollment, 1 month, and 6 months.
Secondary Outcomes (2)
Evaluation of Anxiety and Depression
enrollment, 1 month, and 6 months.
Evaluation of Quality of Life
enrollment, 1 month, and 6 months.
Study Arms (2)
App group
EXPERIMENTALThe intervention group will use a mobile application where patients input their stoma condition, allowing healthcare professionals to monitor and manage their care.
Conventional group
NO INTERVENTIONThe control group consists of patients who received conventional outpatient-based stoma care without using the application service.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients aged 19 years or older
- Patients who have a colostomy or ileostomy after surgery for colon cancer
- Patients who do not have difficulty using a smartphone
You may not qualify if:
- Patients younger than 19 years
- Patients aged 80 years or older
- Patients who do not know how to use a smartphone
- Patients with cognitive impairments
- Patients with pre-existing psychiatric disorders
- Patients who have undergone emergency surgery
- Patients who already have stoma-related complications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2024
First Posted
August 6, 2024
Study Start
September 1, 2024
Primary Completion
August 31, 2025
Study Completion
February 28, 2026
Last Updated
August 9, 2024
Record last verified: 2024-08