Surgical StomasNCT04272528
Construction and Evaluation of a Stoma Patient Care Network
A study testing uniform care and conventional care in people with Surgical Stomas, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
Establish a uniform care network for stoma patients in Shaanxi Province and evaluate its effectiveness, so that stoma patients can get the same quality of stoma care outside the hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Stomas
- What is being tested?
- uniform care and conventional care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2020to 31 Aug 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged ≥18 years old;
- patients undergoing enterostomy;
- patients with primary school and above education level;
- patients with clear consciousness, reading and verbal expression ability;
- patients could reexamine regularly;
- patients informed consent and voluntary participation in the study.
Who cannot join
- patients with organ dysfunction who have difficulty in self-care;
- patients with mental illness, consciousness disorder or communication disorder.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061
Sijie Chen, 0086-17373560562, 1031092940@qq.com
About this study
Official title: Construction and Evaluation of a Uniform Stoma Patient Care Network in Shaanxi Province
Establish a uniform care network for stoma patients in Shaanxi Province and evaluate its effectiveness, so that stoma patients can get the same quality of stoma care outside the hospital.
Read the detailed description
This project plans to take the First Affiliated Hospital of Xi'an Jiaotong University as the lead hospital to establish a uniform care network for stoma patients in Shaanxi Province. This network includes the management system of stoma nursing and the management organization of stoma patients in Shaanxi Province. It formulates the whole quality standard of stoma nursing in Shaanxi Province, carries out "standard training" for the stoma specialty nurses in the group, and carries out on-site inspection in various hospitals from time to time, establishes the feedback mechanism and standardizes the stoma nursing process. The contact card of stoma therapists was made and distributed to patients with stoma, so that patients can easily get the information of stoma therapists in the nearest hospital and receive professional and convenient care. WeChat group of specialized stoma nurses was established to provide remote guidance for difficult cases, share new stoma ideas and knowledge, and facilitate communication among stoma nurses in the group. The leading hospital holds training courses on knowledge and progress of stomatology every year, competitions on knowledge and skills, and dispatches therapists to provide work guidance, so as to share new knowledge, skills and scientific research abilities. At the same time, the efficacy of the network was evaluated by investigating the complication rate, self-care ability, quality of life, medical costs of stoma patients,as well as the specialized nursing skills and professional development of nurses.
- Conditions
- Surgical Stomas
- Being tested
- uniform care, conventional care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uniform careOther
The leader develops training plan and trains nurses, who provide uniform care and education to patients according to the training.
conventional careOther
Nurses carry out the routine care procedures.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Nurses provide uniform care to patients according to the quality standards. Receives: Other: uniform care |
| control group | Placebo comparator | Nurses provide the routine care to patients. Receives: Other: conventional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life measured by Stoma Quality of Life (Stoma-QOL).
The scale includes 20 items with a score ranging from 20 to 80 points. The higher the score, the better the quality of life.
Measured: 6 months
Secondary outcomes (2)
Self-care ability measured by stoma self-care ability scale
The scale includes three dimensions: self intention questionnaire (12-48 points), self-care knowledge (0-21 points), self-care skills (0-12 points). The higher the score, the higher the self-care ability.
Measured: 6 months
Stoma complications
Stoma complications include infection around the stoma，parastomal hernia，skin and mucous membrane separation，fistula of stoma，hemorrhage，ischemia，and stenosis．
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 May 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical StomasStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xia Xin, Study chair, First Affiliated Hospital of Xian Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272528
- Sponsor's protocol ID
- 2019SF-124
- Status last verified
- Aug 2021
- First submitted
- 30 Dec 2019
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Evaluation of a Uniform Stoma Patient Care Network in Shaanxi Province
- ClinicalTrials.gov ID
- NCT04272528
- Acronym / sponsor ID
- 2019SF-124
- Conditions
- Surgical Stomas
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 17 Feb 2020 (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.
Establish a uniform care network for stoma patients in Shaanxi Province and evaluate its effectiveness, so that stoma patients can get the same quality of stoma care outside the hospital.
Detailed description
This project plans to take the First Affiliated Hospital of Xi'an Jiaotong University as the lead hospital to establish a uniform care network for stoma patients in Shaanxi Province. This network includes the management system of stoma nursing and the management organization of stoma patients in Shaanxi Province. It formulates the whole quality standard of stoma nursing in Shaanxi Province, carries out "standard training" for the stoma specialty nurses in the group, and carries out on-site inspection in various hospitals from time to time, establishes the feedback mechanism and standardizes the stoma nursing process. The contact card of stoma therapists was made and distributed to patients with stoma, so that patients can easily get the information of stoma therapists in the nearest hospital and receive professional and convenient care. WeChat group of specialized stoma nurses was established to provide remote guidance for difficult cases, share new stoma ideas and knowledge, and facilitate communication among stoma nurses in the group. The leading hospital holds training courses on knowledge and progress of stomatology every year, competitions on knowledge and skills, and dispatches therapists to provide work guidance, so as to share new knowledge, skills and scientific research abilities. At the same time, the efficacy of the network was evaluated by investigating the complication rate, self-care ability, quality of life, medical costs of stoma patients,as well as the specialized nursing skills and professional development of nurses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: uniform careNurses provide uniform care to patients according to the quality standards. |
| control group | Placebo comparator | Other: conventional careNurses provide the routine care to patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients aged ≥18 years old;
- patients undergoing enterostomy;
- patients with primary school and above education level;
- patients with clear consciousness, reading and verbal expression ability;
- patients could reexamine regularly;
Key exclusion criteria (2 listed)
- patients with organ dysfunction who have difficulty in self-care;
- patients with mental illness, consciousness disorder or communication disorder.
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 |
|---|---|---|
| uniform careThe leader develops training plan and trains nurses, who provide uniform care and education to patients according to the training. | Other | experimental group |
| conventional careNurses carry out the routine care procedures. | Other | control group |
Primary outcome
Quality of life measured by Stoma Quality of Life (Stoma-QOL).
Time frame: 6 months
The scale includes 20 items with a score ranging from 20 to 80 points. The higher the score, the better the quality of life.
2 secondary outcomes
Self-care ability measured by stoma self-care ability scale
Time frame: 6 months
Stoma complications
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- 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.
Xia Xin study chair
First Affiliated Hospital of Xian Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing uniform care and conventional care in people with Surgical Stomas, run by First Affiliated Hospital Xi'an Jiaotong University 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 6 inclusion and 2 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 2 Sep 2021. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sijie Chen (0086-17373560562, 1031092940@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life measured by Stoma Quality of Life (Stoma-QOL). (time frame: 6 months). 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 2 Sep 2021.