Digital Based Home Care Service for Ostomy Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-79
SponsorWonju Severance Christian Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
The Use of a Mobile Application for Stoma Self-Care
BehavioralThe 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: App groupExperimental treatment 1 intervention
Group B: Conventional groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Peristomal Dermatitis
Evaluated using the DET Score (Discoloration, Erosion, and Tissue Overgrowth) on a scale ranging from 0 to 3.
Time frame
enrollment, 1 month, and 6 months.2
Wound Infection, stoma retraction, bleeding, hernia, and Acute kidney injury
Incidence rate as a percentage of patients affected.
Time frame
enrollment, 1 month, and 6 months.3
Readmission Rate
Incidence rate as the percentage of patients readmitted due to stoma-related complications.
Time frame
enrollment, 1 month, and 6 months.Secondary outcomes
1
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."
Time frame
enrollment, 1 month, and 6 months.2
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
Time frame
enrollment, 1 month, and 6 months.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Wonju Severance Christian Hospital
Lead sponsor
The Korean Society of Coloproctology
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: