Digital Based Home Care Service for Ostomy Patients

Trial Title: Digital Based Home Care Service for Ostomy Patients

NCT ID: NCT06540430

Condition: Colorectal Neoplasms
Stoma Colostomy
Stoma Ileostomy

Conditions: Official terms:
Colorectal Neoplasms

Conditions: Keywords:
Stoma
Colorectal neoplasms
Quality of life

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: The intervention group will use a mobile application where patients input their stoma condition, allowing healthcare professionals to monitor and manage their care. The control group consists of patients who received conventional outpatient-based stoma care without using the application service.

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: The Use of a Mobile Application for Stoma Self-Care
Description: 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.
Arm group label: App group

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.

Criteria for 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

Gender: All

Minimum age: 19 Years

Maximum age: 79 Years

Healthy volunteers: No

Start date: September 1, 2024

Completion date: February 28, 2026

Lead sponsor:
Agency: Wonju Severance Christian Hospital
Agency class: Other

Collaborator:
Agency: The Korean Society of Coloproctology
Agency class: Other

Source: Wonju Severance Christian Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06540430