Digital Based Home Care Service for Ostomy Patients

NCT ID: NCT06540430

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2026-02-28

Brief Summary

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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

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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.

Conditions

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Colorectal Neoplasms Stoma Colostomy Stoma Ileostomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

The Use of a Mobile Application for Stoma Self-Care

Intervention Type BEHAVIORAL

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.

Conventional group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Korean Society of Coloproctology

UNKNOWN

Sponsor Role collaborator

Wonju Severance Christian Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Sanghyun An, M.D., Ph.D.

Role: CONTACT

82)10-4782-2818

Ik-Yong Kim, M.D., Ph.D.

Role: CONTACT

82)10-4644-5508

Other Identifiers

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Ostocare2024

Identifier Type: -

Identifier Source: org_study_id

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