EnterostomyNCT06855082
A Study of Using the Stoma Self-care Apps by Patients With Enterostomy
A study testing stoma self-care apps and Traditional Education Receive colostomy health education manual with oral instruction in people with Enterostomy, run by HSIN LING CHEN at 1 site in Taiwan.
Trial summary
This study uses a stoma self-care app, accessed through LINE official account, a communication software commonly used by Chinese people, as an intervention measure to integrate technology acceptance and task technology adaptation models to explore the correlation of each aspect and its impact on self-care ability and… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Enterostomy
- What is being tested?
- stoma self-care apps and Traditional Education Receive colostomy health education manual with oral instruction
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Mar 2025to 1 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with colorectal cancer or intestinal obstruction or abdominal trauma, those who have received colostomy during this hospitalization
- Conscious, can communicate in Mandarin or Minnan dialect
- Have no communication, vision, or hearing impairments,
- Have smartphones
Who cannot join
- Those who are unable to cooperate due to visual, hearing, cognitive or mental impairments
- Patients who need colostomy surgery due to non-colorectal cancer, intestinal obstruction, or abdominal trauma
- Patients diagnosed by a physician as having surgery-related complications and requiring further surgery, such as infection, intestinal Perforation, stoma prolapse, stenosis, necrosis, bleeding, etc. (IV) Those who are unable to learn self-care on the day before discharge due to worsening of their illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of Using the Stoma Self-care Apps by Patients With Enterostomy on the Integrated Model of Technology Acceptance (TAM) and Task-technology Fit(TTF)
This study uses a stoma self-care app, accessed through LINE official account, a communication software commonly used by Chinese people, as an intervention measure to integrate technology acceptance and task technology adaptation models to explore the correlation of each aspect and its impact on self-care ability and quality of life. Whether the factors and task technology adaptability will affect the willingness and usage behavior of enterostomy patients, the research subjects can effectively improve their self-care ability, quality of life, usage willingness, and usage behavior after intervention.
Read the detailed description
Background: Self-care for patients after enterostomy surgery includes both cognitive and skill aspects. Insufficient self-care ability, inability to tell self-care precautions, and incorrect steps in performing care skills lead to leakage of the ostomy bag, and 70% of peristomal skin lesions occur. Complications lead to increased hospitalization days, readmission rates, and medical costs. Pain and other discomforts caused by skin complications around the stoma can cause anxiety, depression or anger, followed by financial burdens and impacts on families, affecting the quality of life. Ostomates use paper texts and oral instructions to provide post-enterostomy nursing care instructions. There is no regular follow-up mechanism after discharge. After returning home, enterostomy patients' self-care ability and adaptability to the stoma will be tested. Changes in the defecation outlet after enterostomy surgery affect many aspects. Patients need to relearn daily care. Physically, they need to maintain the cleanliness of the ostomy bag collection system at all times. Their lifestyle must be consistent with postoperative diet and exercise. Changes; psychologically, the changes in body function and appearance, anxiety, depression, or anger caused in the process of adapting to the enterostomy lifestyle, followed by the financial burden and impact on the family, and the physical, mental, and spiritual impact of family members on each other. It is a huge change, providing ongoing care guidance and support to ensure self-care and quality of life after returning home, meeting the constraints faced by patients with enterostomy needs and the challenges faced by their care guidance.
Purpose: This study uses a stoma self-care app, accessed through LINE official account, a communication software commonly used by Chinese people, as an intervention measure to integrate technology acceptance and task technology adaptation models to explore the correlation of each aspect and its impact on self-care ability and quality of life. Whether the factors and task technology adaptability will affect the willingness and usage behavior of enterostomy patients, the research subjects can effectively improve their self-care ability, quality of life, usage willingness, and usage behavior after intervention.
Method: It is a quantitative, single-blind, simple randomly assigned, quasi-experimental study. The surgical ward and stoma treatment room of a medical center in northern Taiwan accepted patients with enterostomy, including 25 patients in the control group and 25 patients in the experimental group. The interventional measures were performed on the first day after enterostomy surgery, using integrated technology to receive and adapt task technology. Model, the enterostomy self-care knowledge scale, and the stoma self-care ability scale (UES) are used to evaluate self-care ability, and the stoma patient quality of life scale (Stoma-QOL) is used to evaluate the quality of life, and a questionnaire survey is conducted. Analyze task technology fit.
- Conditions
- Enterostomy
- Being tested
- stoma self-care apps, Traditional Education Receive colostomy health education manual with oral instruction
- Keywords
- Enterostomy, stoma self-care apps, Technology Acceptance Model, Task Technology Fit Model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stoma self-care appsBehavioural
This study uses a stoma self-care app, accessed through LINE official account, a communication software commonly used by Chinese people, as an intervention measure to integrate technology acceptance and task technology adaptation models to explore the correlation of each aspect and its impact on self-care ability and quality of life. Whether the factors and task technology adaptability will affect the willingness and usage behavior of enterostomy patients, the research subjects can effectively improve their self-care ability, quality of life, usage willingness, and usage behavior after intervention.
Traditional Education Receive colostomy health education manual with oral instructionBehavioural
conventional
| Study group | Role | What they receive |
|---|---|---|
| stoma self-care apps | Experimental | uses a stoma self-care app, accessed through LINE official account, a communication software commonly used by Chinese people, as an intervention measure to integrate technology acceptance and task technology adaptation models to explore the correlation of each aspect and its impact on self-care ability and quality of life. Receives: Behavioral: stoma self-care apps |
| conventional | Placebo comparator | conventional Traditional Education Receives: Behavioral: Traditional Education Receive colostomy health education manual with oral instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
The quality of life of patients with colostomy
The Stoma-QOL scale was used to measure the quality of life. The score was scored on a 4-point scale ranging from 30 to 120 points. The higher the score, the better the quality of life of the research subjects.
Measured: Day 1 to 28 after colostomy surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start14 Mar 2025
- Primary completion25 Dec 2025
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EnterostomyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Technology Acceptance Model, TAM Task Technology Fit Model, TTF
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- HSIN LING CHEN
- Sponsor type
- University, hospital or other
- Collaborators
- National Taipei University of Nursing and Health Sciences
- Responsible party
- Sponsor-investigator, HSIN LING CHEN, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855082
- Sponsor's protocol ID
- 24MMHIS457e
- Status last verified
- Dec 2025
- First submitted
- 14 Feb 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martins L, Down G, Andersen BD, Nielsen LF, Hansen AS, Herschend NO, Storling Z. The Ostomy Skin Tool 2.0: a new instrument for assessing peristomal skin changes. Br J Nurs. 2022 Apr 21;31(8):442-450. doi: 10.12968/bjon.2022.31.8.442.
PubMed 35439075
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Using the Stoma Self-care Apps by Patients With Enterostomy on the Integrated Model of Technology Acceptance (TAM) and Task-technology Fit(TTF)
- ClinicalTrials.gov ID
- NCT06855082
- Acronym / sponsor ID
- 24MMHIS457e
- Conditions
- Enterostomy
- Keywords
- Enterostomy, stoma self-care apps, Technology Acceptance Model, Task Technology Fit Model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- HSIN LING CHENUniversity, hospital or other
- Collaborators
- National Taipei University of Nursing and Health Sciences
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 25 Dec 2025 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 3 Mar 2025 (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 uses a stoma self-care app, accessed through LINE official account, a communication software commonly used by Chinese people, as an intervention measure to integrate technology acceptance and task technology adaptation models to explore the correlation of each aspect and its impact on self-care ability and quality of life. Whether the factors and task technology adaptability will affect the willingness and usage behavior of enterostomy patients, the research subjects can effectively improve their self-care ability, quality of life, usage willingness, and usage behavior after intervention.
Detailed description
Background: Self-care for patients after enterostomy surgery includes both cognitive and skill aspects. Insufficient self-care ability, inability to tell self-care precautions, and incorrect steps in performing care skills lead to leakage of the ostomy bag, and 70% of peristomal skin lesions occur. Complications lead to increased hospitalization days, readmission rates, and medical costs. Pain and other discomforts caused by skin complications around the stoma can cause anxiety, depression or anger, followed by financial burdens and impacts on families, affecting the quality of life. Ostomates use paper texts and oral instructions to provide post-enterostomy nursing care instructions. There is no regular follow-up mechanism after discharge. After returning home, enterostomy patients' self-care ability and adaptability to the stoma will be tested. Changes in the defecation outlet after enterostomy surgery affect many aspects. Patients need to relearn daily care. Physically, they need to maintain the cleanliness of the ostomy bag collection system at all times. Their lifestyle must be consistent with postoperative diet and exercise. Changes; psychologically, the changes in body function and appearance, anxiety, depression, or anger caused in the process of adapting to the enterostomy lifestyle, followed by the financial burden and impact on the family, and the physical, mental, and spiritual impact of family members on each other. It is a huge change, providing ongoing care guidance and support to ensure self-care and quality of life after returning home, meeting the constraints faced by patients with enterostomy needs and the challenges faced by their care guidance.
Purpose: This study uses a stoma self-care app, accessed through LINE official account, a communication software commonly used by Chinese people, as an intervention measure to integrate technology acceptance and task technology adaptation models to explore the correlation of each aspect and its impact on self-care ability and quality of life. Whether the factors and task technology adaptability will affect the willingness and usage behavior of enterostomy patients, the research subjects can effectively improve their self-care ability, quality of life, usage willingness, and usage behavior after intervention.
Method: It is a quantitative, single-blind, simple randomly assigned, quasi-experimental study. The surgical ward and stoma treatment room of a medical center in northern Taiwan accepted patients with enterostomy, including 25 patients in the control group and 25 patients in the experimental group. The interventional measures were performed on the first day after enterostomy surgery, using integrated technology to receive and adapt task technology. Model, the enterostomy self-care knowledge scale, and the stoma self-care ability scale (UES) are used to evaluate self-care ability, and the stoma patient quality of life scale (Stoma-QOL) is used to evaluate the quality of life, and a questionnaire survey is conducted. Analyze task technology fit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Technology Acceptance Model, TAM Task Technology Fit Model, TTF
| Arm | Type | Receives |
|---|---|---|
| stoma self-care apps | Experimental | Behavioral: stoma self-care appsuses a stoma self-care app, accessed through LINE official account, a communication software commonly used by Chinese people, as an intervention measure to integrate technology acceptance and task technology adaptation models to explore the correlation of each aspect and its impact on self-care ability and quality of life. |
| conventional | Placebo comparator | Behavioral: Traditional Education Receive colostomy health education manual with oral instructionconventional Traditional Education |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with colorectal cancer or intestinal obstruction or abdominal trauma, those who have received colostomy during this hospitalization
- Conscious, can communicate in Mandarin or Minnan dialect
- Have no communication, vision, or hearing impairments,
- Have smartphones
Key exclusion criteria (3 listed)
- Those who are unable to cooperate due to visual, hearing, cognitive or mental impairments
- Patients who need colostomy surgery due to non-colorectal cancer, intestinal obstruction, or abdominal trauma
- Patients diagnosed by a physician as having surgery-related complications and requiring further surgery, such as infection, intestinal Perforation, stoma prolapse, stenosis, necrosis, bleeding, etc. (IV) Those who are unable to learn self-care on the day before discharge due to worsening of their illness.
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 |
|---|---|---|
| stoma self-care appsThis study uses a stoma self-care app, accessed through LINE official account, a communication software commonly used by Chinese people, as an intervention measure to integrate technology acceptance and task technology adaptation models to explore the correlation of each aspect and its impact on self-care ability and quality of life. Whether the factors and task technology adaptability will affect the willingness and usage behavior of enterostomy patients, the research subjects can effectively improve their self-care ability, quality of life, usage willingness, and usage behavior after intervention. | Behavioural | stoma self-care apps |
| Traditional Education Receive colostomy health education manual with oral instructionconventional | Behavioural | conventional |
Primary outcome
The quality of life of patients with colostomy
Time frame: Day 1 to 28 after colostomy surgery
The Stoma-QOL scale was used to measure the quality of life. The score was scored on a 4-point scale ranging from 30 to 120 points. The higher the score, the better the quality of life of the research subjects.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Background: PubMed 35439075Martins L, Down G, Andersen BD, Nielsen LF, Hansen AS, Herschend NO, Storling Z. The Ostomy Skin Tool 2.0: a new instrument for assessing peristomal skin changes. Br J Nurs. 2022 Apr 21;31(8):442-450. doi: 10.12968/bjon.2022.31.8.442.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stoma self-care apps and Traditional Education Receive colostomy health education manual with oral instruction in people with Enterostomy, run by HSIN LING CHEN at 1 site in Taiwan.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The quality of life of patients with colostomy (time frame: Day 1 to 28 after colostomy surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06855082, which also lists 1 linked publication.
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 16 Sep 2026.