Digital Based Home Care Service for Ostomy Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: The Use of a Mobile Application for Stoma Self-Care.
- Who it may be relevant to
- Registry conditions: Colorectal Neoplasms, Stoma Colostomy, Stoma Ileostomy. Basic parameters: 19 years — 79 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Digital Based Home Care Service for Ostomy Patients: Randomized Controlled Trials
Overview
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
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.
Interventions
- 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.
Primary outcome measures
- Peristomal Dermatitis [Time frame: enrollment, 1 month, and 6 months.]
- Wound Infection, stoma retraction, bleeding, hernia, and Acute kidney injury [Time frame: enrollment, 1 month, and 6 months.]
- Readmission Rate [Time frame: enrollment, 1 month, and 6 months.]
Secondary outcome measures (2)
- Evaluation of Anxiety and Depression [Time frame: enrollment, 1 month, and 6 months.]
- Evaluation of Quality of Life [Time frame: enrollment, 1 month, and 6 months.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06540430 · Ostocare2024