Digital Based Home Care Service for Ostomy Patients

Wonju Severance Christian Hospital

Status: Not yet enrolling

Conditions: Stoma Colostomy; Stoma Ileostomy; Colorectal Neoplasms

Treatments: Behavioral: The Use of a Mobile Application for Stoma Self-Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06540430

Ostocare2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 19 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

App group

Experimental group

Description:

The intervention group will use a mobile application where patients input their stoma condition, allowing healthcare professionals to monitor and manage their care.

Treatment:

Behavioral: The Use of a Mobile Application for Stoma Self-Care

Conventional group

No Intervention group

Description:

The control group consists of patients who received conventional outpatient-based stoma care without using the application service.