Colorectal NeoplasmsNCT06540430
Digital Based Home Care Service for Ostomy Patients
A study testing The Use of a Mobile Application for Stoma Self-Care in people with Colorectal Neoplasms and Stoma Colostomy, run by Wonju Severance Christian Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Colorectal Neoplasms, Stoma Colostomy, Stoma Ileostomy
- What is being tested?
- The Use of a Mobile Application for Stoma Self-Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Neoplasms, Stoma Colostomy, Stoma Ileostomy
- Being tested
- The Use of a Mobile Application for Stoma Self-Care
- Keywords
- Stoma, Colorectal neoplasms, Quality of life
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Use of a Mobile Application for Stoma Self-CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| App group | Experimental | The intervention group will use a mobile application where patients input their stoma condition, allowing healthcare professionals to monitor and manage their care. Receives: Behavioral: The Use of a Mobile Application for Stoma Self-Care |
| Conventional group | No intervention | The control group consists of patients who received conventional outpatient-based stoma care without using the application service. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peristomal Dermatitis
Evaluated using the DET Score (Discoloration, Erosion, and Tissue Overgrowth) on a scale ranging from 0 to 3.
Measured: enrollment, 1 month, and 6 months.
Wound Infection, stoma retraction, bleeding, hernia, and Acute kidney injury
Incidence rate as a percentage of patients affected.
Measured: enrollment, 1 month, and 6 months.
Readmission Rate
Incidence rate as the percentage of patients readmitted due to stoma-related complications.
Measured: enrollment, 1 month, and 6 months.
Secondary outcomes (2)
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."
Measured: enrollment, 1 month, and 6 months.
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
Measured: enrollment, 1 month, and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wonju Severance Christian Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Korean Society of Coloproctology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540430
- Sponsor's protocol ID
- Ostocare2024
- Status last verified
- Aug 2024
- First submitted
- 29 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Based Home Care Service for Ostomy Patients: Randomized Controlled Trials
- ClinicalTrials.gov ID
- NCT06540430
- Acronym / sponsor ID
- Ostocare2024
- Conditions
- Colorectal Neoplasms, Stoma Colostomy, Stoma Ileostomy
- Keywords
- Stoma, Colorectal neoplasms, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Wonju Severance Christian HospitalUniversity, hospital or other
- Collaborators
- The Korean Society of Coloproctology
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| App group | Experimental | Behavioral: The Use of a Mobile Application for Stoma Self-CareThe intervention group will use a mobile application where patients input their stoma condition, allowing healthcare professionals to monitor and manage their care. |
| Conventional group | No intervention | –The control group consists of patients who received conventional outpatient-based stoma care without using the application service. |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Use of a Mobile Application for Stoma Self-CareThe 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. | Behavioural | App group |
Primary outcome
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.
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.
Readmission Rate
Time frame: enrollment, 1 month, and 6 months.
Incidence rate as the percentage of patients readmitted due to stoma-related complications.
2 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing The Use of a Mobile Application for Stoma Self-Care in people with Colorectal Neoplasms and Stoma Colostomy, run by Wonju Severance Christian Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sanghyun An, M.D., Ph.D. (82)10-4782-2818, uldura@yonsei.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peristomal Dermatitis (time frame: enrollment, 1 month, and 6 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.