Urinary Bladder NeoplasmsNCT07201441
The Impact of Intelligent Nursing Based on Health Cloud Platform on Active Health Management of Urostomy Patients
A study testing Smart Nursing Based on the Health Cloud Platform in people with Urinary Bladder Neoplasms, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
Research data show that the incidence of bladder tumors in China ranks first among malignant tumors of the urinary system and is on the rise . Muscle - invasive bladder tumor is a fatal malignant tumor, and radical cystectomy with urinary diversion is the main treatment method . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Urinary Bladder Neoplasms
- What is being tested?
- Smart Nursing Based on the Health Cloud Platform
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2023to 20 Sep 2025
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those with clear consciousness, distinct self - expression and without mental abnormalities.
- Individuals whose age is between 18 and 80 years old (inclusive), and whose self - care ability (Barthel Index) score is greater than 90 points.
- Those who are clearly aware of the diagnosis and have undergone total cystectomy with urostomy.
- Patients without depression. Patients or their family members are able to use WeChat. Voluntarily participate in this study and sign the informed consent form.
Who cannot join
- Patients with tumor metastasis or combined with other tumors. Those with visual impairment. Vulnerable groups, including patients with mental illnesses, those with cognitive impairment, critically ill patients, minors, pregnant women, illiterate people, etc.
Trial locations and contacts
1 site in 1 country.
China1 site
Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
About this study
Research data show that the incidence of bladder tumors in China ranks first among malignant tumors of the urinary system and is on the rise . Muscle - invasive bladder tumor is a fatal malignant tumor, and radical cystectomy with urinary diversion is the main treatment method . After urinary diversion, patients rely on urostomy for urination for life, unable to control urine at will, and need to wear ostomy bags for life, resulting in self - image disorder. Urostomy brings a lot of troubles to patients and their families, increases the economic burden, especially makes young patients feel anxious about life, lose confidence in the future, and causes great psychological pressure . Due to the strong professionalism of stoma care, with the improvement of medical technology, the average hospital stay of patients after surgery is shortened, resulting in patients not fully mastering the knowledge and skills of urostomy care at the time of discharge, and their self - care ability is at a low level. They are prone to various health problems, which directly affects the quality of life of patients and their families .
Health is an inevitable requirement for the all - around development of people. The "Healthy China 2030" Plan Outline emphasizes the concept of proactive health. Proactive health refers to long - term, continuous and dynamic tracking of an individual's behavior system, identification and assessment of one's own state, evolution direction and degree, selection of various elements of lifestyle as the main means, giving full play to one's subjective initiative, and conducting controllable interventions on human behavior to improve health behaviors. In 2017, the Ministry of Science and Technology issued a notice officially including proactive health in the special plan. The concept of proactive health management has become an important part of realizing the Healthy China strategy.
Read the detailed description
Proactive health management mainly promotes health through five dimensions: Dimension 1: Improve "proactive health management literacy", Dimension 2: Accurately predict "health risks", Dimension 3: Intelligently warn of "health events", Dimension 4: Effectively intervene in "health outcomes", Dimension 5: Comprehensively improve "health level". Proactive health is needed for healthy people, and proactive health management is even more important for patients. As a special group in society, urostomy patients who face many health problems after discharge need proactive health management even more, as well as the care of their families and society and postoperative rehabilitation guidance .
Traditional post - discharge follow - up methods are time - consuming and energy - consuming, difficult to carry out fully, with a high rate of lost to follow - up and a high incidence of complications . Patients urgently need to solve new problems that occur after discharge. Guo Cheng et al. expounded on relevant suggestions for public hospitals to carry out medical science popularization work in the era of proactive health. As one of the first pilot provinces for "Internet + Nursing" in the country, our hospital responded to the national call and actively launched online nursing information services. The information platform providing online information services is a network virtual platform based on Internet technology with functions of information storage, management, sharing and processing. Our department, based on the hospital's health cloud platform for smart nursing services, shares the patient medical records in the hospital information system, records the information of urostomy patients, regularly pushes personalized health education to patients, regularly assesses patients' stoma care ability, and provides timely evaluation and feedback. At the same time, patients can solve problems through the graphic transmission or telephone consultation on the platform, promoting patients' participation in proactive health management.
At present, the research and practice of continuous nursing abroad have reached a mature stage, mainly including pre - discharge and post - discharge. Before discharge, senior clinical nurses ensure that patients receive appropriate continuous nursing through formulating comprehensive discharge plans. After discharge, community medical staff provide high - quality continuous services to patients . Sun V et al. created a stoma patient self - management program based on telehealth. This program carried out continuous nursing for enterostomy patients by establishing electronic health records, holding video conferences and transmitting graphics and texts.
In China, continuous nursing methods mostly rely on QQ（ Quick Query）, WeChat（ We Chat ） and video, pictures and text to promote postoperative rehabilitation. Mobile phone applications (APPs) based on the Internet, with the characteristics of high informatization, low cost, high speed and meeting individual needs, have become the main form of mobile medicine at present. Ji ping Zhu et al. carried out narrative follow - up nursing services for urostomy patients after discharge using the "Cloud Clinic" APP, reducing patients' postoperative anxiety, improving patients' ability to care for stomas and patient satisfaction. Actively responding to the call of the National Health Commission to carry out "Internet + Nursing Services", Wen et al. constructed an informatized management system for enterostomy patients' nursing based on the hospital information system, achieving the dynamics and comprehensiveness of medical and nursing information records. At the same time, it also provided patients with continuous nursing services such as online consultation and follow - up, but it still cannot achieve data communication between the internal and external networks.
The future development trend is to realize data sharing on the patient informatization management platform, which is convenient for medical staff to query and manage patient information, provides convenience for health consultation of stoma patients, ensures that patients receive timely attention and rehabilitation guidance after discharge, improves patients' self - care ability, reduces the incidence of complications, and improves patients' quality of life.
This study has been supported by the Medical and Health Research Project of Zhejiang Province (No. 2023KY816).
- Conditions
- Urinary Bladder Neoplasms
- Being tested
- Smart Nursing Based on the Health Cloud Platform
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart Nursing Based on the Health Cloud PlatformBehavioural
On the day of surgery, ensure that the patient or their family members have followed the hospital's official account and bound the patient's information. Through the intelligent cloud platform on the mobile device, they can query the patient's inpatient information, such as examination reports and details of inpatient expenses, and also consult and communicate about the patient's condition.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | On the basis of routine nursing, the intelligent cloud platform management mode is added. Receives: Behavioral: Smart Nursing Based on the Health Cloud Platform |
| Control Group | Active comparator | Implement routine nursing. Receives: Behavioral: Smart Nursing Based on the Health Cloud Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urostomy Self - care Score Urostomy Self - care Score Urostomy Self - care Score
Developed by Kristensen , it includes 2 dimensions and 7 items. Each item is divided into 4 levels, scored from 0 to 3 points, with a total score ranging from 0 to 21 points. The higher the score, the higher the patient's self - care level. In 2014, Fu Suliang translated this scale into Chinese and tested its reliability and validity. The content validity index of the Chinese version of the Urostomy Self - care Scale is 0.952, and the Cronbach α coefficient is 0.88. It is suitable for measuring the self - care ability of patients with urostomy.
Measured: The 1st, 3rd, and 6th months after surgery
Secondary outcomes (1)
Anxiety State Score
The Self - Rating Anxiety Scale (SAS) is adopted: Developed by Zung in 1971, it is a self - rating scale containing 20 items with 4 - level scoring.
Measured: The 1st, 3rd, and 6th months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start31 Jan 2023
- Primary completion12 May 2025
- Study completion20 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201441
- Sponsor's protocol ID
- 2023KY816
- Status last verified
- Sep 2025
- First submitted
- 23 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Intelligent Nursing Based on Health Cloud Platform on Active Health Management of Urostomy Patients
- ClinicalTrials.gov ID
- NCT07201441
- Acronym / sponsor ID
- 2023KY816
- Conditions
- Urinary Bladder Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 12 May 2025 (actual)
- Study completion
- 20 Sep 2025 (actual)
- First posted
- 1 Oct 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.
Research data show that the incidence of bladder tumors in China ranks first among malignant tumors of the urinary system and is on the rise . Muscle - invasive bladder tumor is a fatal malignant tumor, and radical cystectomy with urinary diversion is the main treatment method . After urinary diversion, patients rely on urostomy for urination for life, unable to control urine at will, and need to wear ostomy bags for life, resulting in self - image disorder. Urostomy brings a lot of troubles to patients and their families, increases the economic burden, especially makes young patients feel anxious about life, lose confidence in the future, and causes great psychological pressure . Due to the strong professionalism of stoma care, with the improvement of medical technology, the average hospital stay of patients after surgery is shortened, resulting in patients not fully mastering the knowledge and skills of urostomy care at the time of discharge, and their self - care ability is at a low level. They are prone to various health problems, which directly affects the quality of life of patients and their families .
Health is an inevitable requirement for the all - around development of people. The "Healthy China 2030" Plan Outline emphasizes the concept of proactive health. Proactive health refers to long - term, continuous and dynamic tracking of an individual's behavior system, identification and assessment of one's own state, evolution direction and degree, selection of various elements of lifestyle as the main means, giving full play to one's subjective initiative, and conducting controllable interventions on human behavior to improve health behaviors. In 2017, the Ministry of Science and Technology issued a notice officially including proactive health in the special plan. The concept of proactive health management has become an important part of realizing the Healthy China strategy.
Detailed description
Proactive health management mainly promotes health through five dimensions: Dimension 1: Improve "proactive health management literacy", Dimension 2: Accurately predict "health risks", Dimension 3: Intelligently warn of "health events", Dimension 4: Effectively intervene in "health outcomes", Dimension 5: Comprehensively improve "health level". Proactive health is needed for healthy people, and proactive health management is even more important for patients. As a special group in society, urostomy patients who face many health problems after discharge need proactive health management even more, as well as the care of their families and society and postoperative rehabilitation guidance .
Traditional post - discharge follow - up methods are time - consuming and energy - consuming, difficult to carry out fully, with a high rate of lost to follow - up and a high incidence of complications . Patients urgently need to solve new problems that occur after discharge. Guo Cheng et al. expounded on relevant suggestions for public hospitals to carry out medical science popularization work in the era of proactive health. As one of the first pilot provinces for "Internet + Nursing" in the country, our hospital responded to the national call and actively launched online nursing information services. The information platform providing online information services is a network virtual platform based on Internet technology with functions of information storage, management, sharing and processing. Our department, based on the hospital's health cloud platform for smart nursing services, shares the patient medical records in the hospital information system, records the information of urostomy patients, regularly pushes personalized health education to patients, regularly assesses patients' stoma care ability, and provides timely evaluation and feedback. At the same time, patients can solve problems through the graphic transmission or telephone consultation on the platform, promoting patients' participation in proactive health management.
At present, the research and practice of continuous nursing abroad have reached a mature stage, mainly including pre - discharge and post - discharge. Before discharge, senior clinical nurses ensure that patients receive appropriate continuous nursing through formulating comprehensive discharge plans. After discharge, community medical staff provide high - quality continuous services to patients . Sun V et al. created a stoma patient self - management program based on telehealth. This program carried out continuous nursing for enterostomy patients by establishing electronic health records, holding video conferences and transmitting graphics and texts.
In China, continuous nursing methods mostly rely on QQ（ Quick Query）, WeChat（ We Chat ） and video, pictures and text to promote postoperative rehabilitation. Mobile phone applications (APPs) based on the Internet, with the characteristics of high informatization, low cost, high speed and meeting individual needs, have become the main form of mobile medicine at present. Ji ping Zhu et al. carried out narrative follow - up nursing services for urostomy patients after discharge using the "Cloud Clinic" APP, reducing patients' postoperative anxiety, improving patients' ability to care for stomas and patient satisfaction. Actively responding to the call of the National Health Commission to carry out "Internet + Nursing Services", Wen et al. constructed an informatized management system for enterostomy patients' nursing based on the hospital information system, achieving the dynamics and comprehensiveness of medical and nursing information records. At the same time, it also provided patients with continuous nursing services such as online consultation and follow - up, but it still cannot achieve data communication between the internal and external networks.
The future development trend is to realize data sharing on the patient informatization management platform, which is convenient for medical staff to query and manage patient information, provides convenience for health consultation of stoma patients, ensures that patients receive timely attention and rehabilitation guidance after discharge, improves patients' self - care ability, reduces the incidence of complications, and improves patients' quality of life.
This study has been supported by the Medical and Health Research Project of Zhejiang Province (No. 2023KY816).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Smart Nursing Based on the Health Cloud PlatformOn the basis of routine nursing, the intelligent cloud platform management mode is added. |
| Control Group | Active comparator | Behavioral: Smart Nursing Based on the Health Cloud PlatformImplement routine nursing. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Those with clear consciousness, distinct self - expression and without mental abnormalities.
- Individuals whose age is between 18 and 80 years old (inclusive), and whose self - care ability (Barthel Index) score is greater than 90 points.
- Those who are clearly aware of the diagnosis and have undergone total cystectomy with urostomy.
- Patients without depression. Patients or their family members are able to use WeChat. Voluntarily participate in this study and sign the informed consent form.
Key exclusion criteria (1 listed)
- Patients with tumor metastasis or combined with other tumors. Those with visual impairment. Vulnerable groups, including patients with mental illnesses, those with cognitive impairment, critically ill patients, minors, pregnant women, illiterate people, etc.
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 |
|---|---|---|
| Smart Nursing Based on the Health Cloud PlatformOn the day of surgery, ensure that the patient or their family members have followed the hospital's official account and bound the patient's information. Through the intelligent cloud platform on the mobile device, they can query the patient's inpatient information, such as examination reports and details of inpatient expenses, and also consult and communicate about the patient's condition. | Behavioural | Control Group, Experimental Group |
Primary outcome
Urostomy Self - care Score Urostomy Self - care Score Urostomy Self - care Score
Time frame: The 1st, 3rd, and 6th months after surgery
Developed by Kristensen , it includes 2 dimensions and 7 items. Each item is divided into 4 levels, scored from 0 to 3 points, with a total score ranging from 0 to 21 points. The higher the score, the higher the patient's self - care level. In 2014, Fu Suliang translated this scale into Chinese and tested its reliability and validity. The content validity index of the Chinese version of the Urostomy Self - care Scale is 0.952, and the Cronbach α coefficient is 0.88. It is suitable for measuring the self - care ability of patients with urostomy.
1 secondary outcome
Anxiety State Score
Time frame: The 1st, 3rd, and 6th months after surgery
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 1 Oct 2025.
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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 Smart Nursing Based on the Health Cloud Platform in people with Urinary Bladder Neoplasms, run by Sir Run Run Shaw Hospital at 1 site in China.
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 1 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 1 Oct 2025. 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 China. 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. 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?
Urostomy Self - care Score Urostomy Self - care Score Urostomy Self - care Score (time frame: The 1st, 3rd, and 6th months after surgery). 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 1 Oct 2025.