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Digital Based Home Care Service for Ostomy Patients

W

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)

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.

Trial contacts and locations

0

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Central trial contact

Sanghyun An, M.D., Ph.D.; Ik-Yong Kim, M.D., Ph.D.

Data sourced from clinicaltrials.gov

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