Clinical trial NCT06540430: Digital Based Home Care Service for Ostomy Patients
Official title: Digital Based Home Care Service for Ostomy Patients: Randomized Controlled Trials
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colorectal Neoplasms
Stoma Colostomy
Stoma Ileostomy
Keywords: Stoma
Colorectal neoplasms
Quality of life
Lead sponsor: Wonju Severance Christian Hospital
Sponsor class: OTHER
Collaborators: name: The Korean Society of Coloproctology
First posted: 2024-08-06
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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

Primary outcomes:
measure: Peristomal Dermatitis
timeFrame: enrollment, 1 month, and 6 months.
measure: Wound Infection, stoma retraction, bleeding, hernia, and Acute kidney injury
timeFrame: enrollment, 1 month, and 6 months.
measure: Readmission Rate
timeFrame: enrollment, 1 month, and 6 months.
Secondary outcomes:
measure: Evaluation of Anxiety and Depression
timeFrame: enrollment, 1 month, and 6 months.
measure: Evaluation of Quality of Life
timeFrame: enrollment, 1 month, and 6 months.
Other outcomes:
Locations:
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