Digital Based Home Care Service for Ostomy Patients

Digital Based Home Care Service for Ostomy Patients: Randomized Controlled Trials

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Neoplasms; Stoma Ileostomy; Stoma Colostomy
• Intervention / Treatment: Behavioral: The Use of a Mobile Application for Stoma Self-Care

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sanghyun An, M.D., Ph.D.; Phone Number: 82)10-4782-2818; Email: uldura@yonsei.ac.kr
• Study Contact Backup: Name: Ik-Yong Kim, M.D., Ph.D.; Phone Number: 82)10-4644-5508; Email: iykim@yonsei.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: App group; The intervention group will use a mobile application where patients input their stoma condition, allowing healthcare professionals to monitor and manage their care.	Behavioral: The Use of a Mobile Application for Stoma Self-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.
No Intervention: Conventional group; The control group consists of patients who received conventional outpatient-based stoma care without using the application service.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peristomal Dermatitis	Evaluated using the DET Score (Discoloration, Erosion, and Tissue Overgrowth) on a scale ranging from 0 to 3.	enrollment, 1 month, and 6 months.
Wound Infection, stoma retraction, bleeding, hernia, and Acute kidney injury	Incidence rate as a percentage of patients affected.	enrollment, 1 month, and 6 months.
Readmission Rate	Incidence rate as the percentage of patients readmitted due to stoma-related complications.	enrollment, 1 month, and 6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Anxiety and Depression	The EuroQol-5 Dimension (EQ-5D) will be utilized to gauge the general health status. The EQ-5D-5L score consists of two components. One component is the Visual Analogue Scale (VAS), which assesses an individual's overall health status on a scale from 0 to 100. A score of 0 represents "the worst imaginable health state," while a score of 100 represents "the best imaginable health state." The other component assesses health status across five dimensions, each rated on a five-level scale ranging from 1 (no problems) to 5 (extreme problems). The combination of these five dimensions represents a specific health state, and a value set specific to each country is used to calculate a score based on this state. This score typically ranges from 0 to 1, with 1 indicating "perfect health."	enrollment, 1 month, and 6 months.
Evaluation of Quality of Life	The Stoma Quality-of-Life Scale will be used to assess the quality of life specifically related to stoma management and its impacts. The Stoma-QoL questionnaire consists of 20 questions, with a total score range from 20 to 80. Higher scores indicate a better quality of lif	enrollment, 1 month, and 6 months.

Collaborators and Investigators

• Sponsor: Wonju Severance Christian Hospital
• Collaborators: The Korean Society of Coloproctology

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: August 1, 2024
• First Posted (Actual): August 6, 2024

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 6, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Quality of life; Colorectal neoplasms; Stoma
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: Ostocare2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No