Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06540430

Digital Based Home Care Service for Ostomy Patients

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Stoma Colostomy Stoma Ileostomy

Age range

19 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The Use of a Mobile Application for Stoma Self-Care

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.

Primary outcomes

  1. 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.

  2. 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.

  3. Readmission Rate

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

    Incidence rate as the percentage of patients readmitted due to stoma-related complications.

Secondary outcomes

  1. 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."

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

82)10-4644-5508

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

CONTACT

[email protected]

82)10-4782-2818

Sponsors and collaborators

Lead sponsor

Wonju Severance Christian Hospital

Other

Collaborators

  • The Korean Society of Coloproctology

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 6, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.