Digital Based Home Care Service for Ostomy Patients

August 6, 2024 updated by: Wonju Severance Christian Hospital

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: enrollment, 1 month, and 6 months.
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
Time Frame: enrollment, 1 month, and 6 months.
Incidence rate as a percentage of patients affected.
enrollment, 1 month, and 6 months.
Readmission Rate
Time Frame: enrollment, 1 month, and 6 months.
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
Time Frame: enrollment, 1 month, and 6 months.

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
Time Frame: enrollment, 1 month, and 6 months.

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

This is where you will find people and organizations involved with this study.

Sponsor

Wonju Severance Christian Hospital

Collaborators

The Korean Society of Coloproctology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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