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Remote Real-Time Guidance System in Home Care of Patients With PICC or PORT (RRTGS)

Primary Purpose

Gastrointestinal Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Real-Time Guidance of Home Care for Patients with PICC or PORT
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Suffering from psychological disorders and not able to communicate normally
  • Unable to cooperate due to other factors

Sites / Locations

  • First Affiliated Hospital of Xian Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

family self-nursing mode

hospital nursing mode

Arm Description

Outcomes

Primary Outcome Measures

Average level of service life of the catheter
Average length of service life of PICC or PORT
Incidence of puncture point infection
Incidence of puncture point infection of PICC or PORT
Incidence of catheter occlusion
Incidence of catheter occlusion of PICC or PORT
Degree of satisfaction of patients and their families
a satisfaction survey of patients and their families, using a self-designed questionnaire.

Secondary Outcome Measures

Full Information

First Posted
September 16, 2021
Last Updated
March 20, 2022
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT05106244
Brief Title
Remote Real-Time Guidance System in Home Care of Patients With PICC or PORT
Acronym
RRTGS
Official Title
The Application of Remote Real-Time Guidance System in Home Care of Patients With PICC or PORT
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
family self-nursing mode
Arm Type
Experimental
Arm Title
hospital nursing mode
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Real-Time Guidance of Home Care for Patients with PICC or PORT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Average level of service life of the catheter
Description
Average length of service life of PICC or PORT
Time Frame
up to 10 months
Title
Incidence of puncture point infection
Description
Incidence of puncture point infection of PICC or PORT
Time Frame
up to 10 months
Title
Incidence of catheter occlusion
Description
Incidence of catheter occlusion of PICC or PORT
Time Frame
up to 10 months
Title
Degree of satisfaction of patients and their families
Description
a satisfaction survey of patients and their families, using a self-designed questionnaire.
Time Frame
up to 10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Suffering from psychological disorders and not able to communicate normally Unable to cooperate due to other factors
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Zhang, Doctor
Phone
0086-13709110938
Email
13709110938@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
XinRui Zhou, Bachelor's Degree
Phone
0086-15102937212
Email
3022658878@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Zhang, Doctor
Organizational Affiliation
First Affiliated Hospital of Xian Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital of Xian Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Zhang, Doctor
Phone
0086-13709110938
Email
13709110938@163.com
First Name & Middle Initial & Last Name & Degree
XinRui Zhou, Bachelor's Degree
Phone
0086-15102937212
Email
3022658878@qq.com

12. IPD Sharing Statement

Learn more about this trial

Remote Real-Time Guidance System in Home Care of Patients With PICC or PORT

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