Gastrointestinal NeoplasmsRRTGSNCT05106244
Remote Real-Time Guidance System in Home Care of Patients With PICC or PORT
A study testing Real-Time Guidance of Home Care for Patients with PICC or PORT in people with Gastrointestinal Neoplasms, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
Clinical treatment of digestive tract tumor patients often need chemotherapy before and after operation, most chemotherapy drugs will cause harm to patients, prone to leakage, leading to tissue necrosis. The construction of deep venous channels can protect the blood vessels of patients and reduce their pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastrointestinal Neoplasms
- What is being tested?
- Real-Time Guidance of Home Care for Patients with PICC or PORT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 30 Aug 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with gastric cancer or colorectal cancer with indwelling central venous catheter (PICC or PORT)
- Age ≥18 years and ≤75 years
- Normal cognitive function
- Be informed of and actively cooperate with this study
Who cannot join
- Suffering from psychological disorders and not able to communicate normally
- Unable to cooperate due to other factors
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
Yong Zhang, Doctor, 0086-13709110938, 13709110938@163.com
XinRui Zhou, Bachelor's Degree, 0086-15102937212, 3022658878@qq.com
About this study
Official title: The Application of Remote Real-Time Guidance System in Home Care of Patients With PICC or PORT
Clinical treatment of digestive tract tumor patients often need chemotherapy before and after operation, most chemotherapy drugs will cause harm to patients, prone to leakage, leading to tissue necrosis. The construction of deep venous channels can protect the blood vessels of patients and reduce their pain. PICC and PORT have become a new clinical treatment technology, and have become the mainstream mode of long-term intravenous indwelling. Although the central venous catheterization technology has many advantages, it also has some limitations. Because of its long-term existence, periodic nursing needs to be carried out, such as correct flushing, sealing, replacement of film and so on. Incorrect care or failure to come to the hospital on time may lead to abnormal use of the catheter or shortening of service life, resulting in some unexpected pain. Under the influence of COVID-19 's epidemic situation, it becomes more difficult and unrealistic for patients to come to hospital regularly for nursing. During the epidemic, patients need more safe and effective care at home. In order to help patients with good central venous catheter nursing at home, this study intends to apply remote professional real-time guidance technology to home nursing care of PICC and PORT tumor patients. Through on-site practical operation training, video explanation materials of long-distance on-line decomposition steps and real-time telephone audio connection guidance are provided to enable patients' families to quickly learn to master nursing techniques, so as to achieve safe and effective self-care at home.
Read the detailed description
From January 2022 to October 2022, 200 patients with digestive tract tumors with indwelling PICC or PORT in the inpatient department of oncology surgery in First Affiliated Hospital of Xian Jiaotong University were randomly divided into control group (hospital nursing mode) and experimental group (family self-nursing mode) . The specific methods were as follows: 2-1 the control group adopted regular nursing mode after catheterization. The patients were mainly given on-site catheterization nursing by specialist nurses, and health consultation and guidance were carried out during the period of catheterization. 2-2 the experimental group adopted the family self-nursing mode, mainly by the patients' family members to observe the catheter and do regular nursing, and the specialist nurses provided remote real-time online guidance to monitor the family nursing of central venous catheter. The specific operation procedures are as follows: (1) make nursing videos recorded and reviewed by central venous catheter specialist nurses (video production is carried out separately for different central venous access devices from different manufacturers, as well as follow-up training steps). (2) evaluate the nursing operation ability of the patients' family members and carry out relevant training and health education, including hand washing, aseptic concept, matters needing attention in removing the film, flushing and sealing techniques, and local observation points at the puncture point, etc., repeatedly strengthen the training of key links and conduct assessment until the participants are qualified; (3) distribute nursing guidance prescriptions and maintenance manuals for central venous catheters. (4) provide online simulated realistic nursing video materials, nursing video materials are decomposed in detailed steps, each step is equipped with detailed language explanation and explanation, and the key links are reminders or warnings. It is convenient for patients' families to learn and master quickly; (5) provide real-time telephone audio and video connection to complete remote nursing guidance. (6) set up a home nursing volunteer service group, which is composed of nursing team members led by central venous catheter specialist nurses, establish a doctor-patient exchange group by using Wechat and other media, and provide nursing outpatient information of each central venous catheter in the area. Improve family nursing failure remedial measures, provide necessary guidance and help, and timely feedback. The normal service life of the catheter, the infection rate of the catheter puncture point, the catheter occlusion rate, the nursing experience and satisfaction of the patients and their families were compared between the two groups. Statistical processing: the data were analyzed by SPSS22.0 software. The measurement data are expressed as mean ± standard deviation, t-test is used, counting data is expressed as rate (%), and 2 test or Fisher exact probability method is used.
- Conditions
- Gastrointestinal Neoplasms
- Being tested
- Real-Time Guidance of Home Care for Patients with PICC or PORT
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-Time Guidance of Home Care for Patients with PICC or PORTOther
the experimental group adopted the family self-nursing mode, mainly by the patients' family members to observe the catheter and do regular nursing, and the specialist nurses provided remote real-time online guidance to monitor the family nursing of central venous catheter. The procedures are as follows: (1) make nursing videos recorded by central venous catheter specialist nurses; (2) evaluate the nursing operation ability of the patients' family members and carry out relevant training and health education, repeat until they are qualified; (3) distribute nursing guidance prescriptions and maintenance manuals for central venous catheters; (4) provide online simulated realistic nursing video materials; (5) provide real-time telephone audio and video connection to complete remote nursing guidance. (6) set up a home nursing volunteer service group, establish a doctor-patient exchange group by using Wechat and other media.
| Study group | Role | What they receive |
|---|---|---|
| family self-nursing mode | Experimental | Not described Receives: Other: Real-Time Guidance of Home Care for Patients with PICC or PORT |
| hospital nursing mode | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average level of service life of the catheter
Average length of service life of PICC or PORT
Measured: up to 10 months
Incidence of puncture point infection
Incidence of puncture point infection of PICC or PORT
Measured: up to 10 months
Incidence of catheter occlusion
Incidence of catheter occlusion of PICC or PORT
Measured: up to 10 months
Degree of satisfaction of patients and their families
a satisfaction survey of patients and their families, using a self-designed questionnaire.
Measured: up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start1 Jan 2022
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal NeoplasmsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yong Zhang, Doctor, Principal investigator, First Affiliated Hospital of Xian Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106244
- Sponsor's protocol ID
- XJTU1AF2021LSK-300
- Acronym
- RRTGS
- Status last verified
- Sep 2023
- First submitted
- 16 Sep 2021
- Last updated
- 3 Apr 2024
- 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 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Remote Real-Time Guidance System in Home Care of Patients With PICC or PORT
- ClinicalTrials.gov ID
- NCT05106244
- Acronym / sponsor ID
- RRTGS / XJTU1AF2021LSK-300
- Conditions
- Gastrointestinal Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 3 Nov 2021 (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.
Clinical treatment of digestive tract tumor patients often need chemotherapy before and after operation, most chemotherapy drugs will cause harm to patients, prone to leakage, leading to tissue necrosis. The construction of deep venous channels can protect the blood vessels of patients and reduce their pain. PICC and PORT have become a new clinical treatment technology, and have become the mainstream mode of long-term intravenous indwelling. Although the central venous catheterization technology has many advantages, it also has some limitations. Because of its long-term existence, periodic nursing needs to be carried out, such as correct flushing, sealing, replacement of film and so on. Incorrect care or failure to come to the hospital on time may lead to abnormal use of the catheter or shortening of service life, resulting in some unexpected pain. Under the influence of COVID-19 's epidemic situation, it becomes more difficult and unrealistic for patients to come to hospital regularly for nursing. During the epidemic, patients need more safe and effective care at home. In order to help patients with good central venous catheter nursing at home, this study intends to apply remote professional real-time guidance technology to home nursing care of PICC and PORT tumor patients. Through on-site practical operation training, video explanation materials of long-distance on-line decomposition steps and real-time telephone audio connection guidance are provided to enable patients' families to quickly learn to master nursing techniques, so as to achieve safe and effective self-care at home.
Detailed description
From January 2022 to October 2022, 200 patients with digestive tract tumors with indwelling PICC or PORT in the inpatient department of oncology surgery in First Affiliated Hospital of Xian Jiaotong University were randomly divided into control group (hospital nursing mode) and experimental group (family self-nursing mode) . The specific methods were as follows: 2-1 the control group adopted regular nursing mode after catheterization. The patients were mainly given on-site catheterization nursing by specialist nurses, and health consultation and guidance were carried out during the period of catheterization. 2-2 the experimental group adopted the family self-nursing mode, mainly by the patients' family members to observe the catheter and do regular nursing, and the specialist nurses provided remote real-time online guidance to monitor the family nursing of central venous catheter. The specific operation procedures are as follows: (1) make nursing videos recorded and reviewed by central venous catheter specialist nurses (video production is carried out separately for different central venous access devices from different manufacturers, as well as follow-up training steps). (2) evaluate the nursing operation ability of the patients' family members and carry out relevant training and health education, including hand washing, aseptic concept, matters needing attention in removing the film, flushing and sealing techniques, and local observation points at the puncture point, etc., repeatedly strengthen the training of key links and conduct assessment until the participants are qualified; (3) distribute nursing guidance prescriptions and maintenance manuals for central venous catheters. (4) provide online simulated realistic nursing video materials, nursing video materials are decomposed in detailed steps, each step is equipped with detailed language explanation and explanation, and the key links are reminders or warnings. It is convenient for patients' families to learn and master quickly; (5) provide real-time telephone audio and video connection to complete remote nursing guidance. (6) set up a home nursing volunteer service group, which is composed of nursing team members led by central venous catheter specialist nurses, establish a doctor-patient exchange group by using Wechat and other media, and provide nursing outpatient information of each central venous catheter in the area. Improve family nursing failure remedial measures, provide necessary guidance and help, and timely feedback. The normal service life of the catheter, the infection rate of the catheter puncture point, the catheter occlusion rate, the nursing experience and satisfaction of the patients and their families were compared between the two groups. Statistical processing: the data were analyzed by SPSS22.0 software. The measurement data are expressed as mean ± standard deviation, t-test is used, counting data is expressed as rate (%), and 2 test or Fisher exact probability method is used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| family self-nursing mode | Experimental | Other: Real-Time Guidance of Home Care for Patients with PICC or PORT |
| hospital nursing mode | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with gastric cancer or colorectal cancer with indwelling central venous catheter (PICC or PORT)
- Age ≥18 years and ≤75 years
- Normal cognitive function
- Be informed of and actively cooperate with this study
Key exclusion criteria (2 listed)
- Suffering from psychological disorders and not able to communicate normally
- Unable to cooperate due to other factors
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 |
|---|---|---|
| Real-Time Guidance of Home Care for Patients with PICC or PORTthe experimental group adopted the family self-nursing mode, mainly by the patients' family members to observe the catheter and do regular nursing, and the specialist nurses provided remote real-time online guidance to monitor the family nursing of central venous catheter. The procedures are as follows: (1) make nursing videos recorded by central venous catheter specialist nurses; (2) evaluate the nursing operation ability of the patients' family members and carry out relevant training and health education, repeat until they are qualified; (3) distribute nursing guidance prescriptions and maintenance manuals for central venous catheters; (4) provide online simulated realistic nursing video materials; (5) provide real-time telephone audio and video connection to complete remote nursing guidance. (6) set up a home nursing volunteer service group, establish a doctor-patient exchange group by using Wechat and other media. | Other | family self-nursing mode |
Primary outcome
Average level of service life of the catheter
Time frame: up to 10 months
Average length of service life of PICC or PORT
Incidence of puncture point infection
Time frame: up to 10 months
Incidence of puncture point infection of PICC or PORT
Incidence of catheter occlusion
Time frame: up to 10 months
Incidence of catheter occlusion of PICC or PORT
Degree of satisfaction of patients and their families
Time frame: up to 10 months
a satisfaction survey of patients and their families, using a self-designed questionnaire.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
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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.
Yong Zhang, Doctor principal investigator
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 Real-Time Guidance of Home Care for Patients with PICC or PORT in people with Gastrointestinal Neoplasms, 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 4 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 3 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong Zhang, Doctor (0086-13709110938, 13709110938@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average level of service life of the catheter (time frame: up to 10 months). The study lists 4 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 3 Apr 2024.