Digital Based Home Care Service for Ostomy Patients: Randomized Controlled Trials
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Neoplasms
- Sponsor
- Wonju Severance Christian Hospital
- Enrollment
- 120
- Primary Endpoint
- Wound Infection, stoma retraction, bleeding, hernia, and Acute kidney injury
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Wound Infection, stoma retraction, bleeding, hernia, and Acute kidney injury
Time Frame: enrollment, 1 month, and 6 months.
Incidence rate as a percentage of patients affected.
Readmission Rate
Time Frame: enrollment, 1 month, and 6 months.
Incidence rate as the percentage of patients readmitted due to stoma-related complications.
Peristomal Dermatitis
Time Frame: enrollment, 1 month, and 6 months.
Evaluated using the DET Score (Discoloration, Erosion, and Tissue Overgrowth) on a scale ranging from 0 to 3.
Secondary Outcomes
- Evaluation of Anxiety and Depression(enrollment, 1 month, and 6 months.)
- Evaluation of Quality of Life(enrollment, 1 month, and 6 months.)