Construction and Application of Precise Health Education Model for Patients With PICC Tube

1. In this study, the risk factors leading to catheter-related complications in the daily life behavior habits of patients with PICC catheter were identified, refined and initially established, and the Delphi method (expert consultation method) was used to further identify the existing and potential risk factors leading to PICC catheter-related complications in the daily life behavior habits of patients. To develop individualized and precise health education programs for risk factors, in order to build an accurate health education model centered on improving patients' daily life and behavior habits.
2. To conduct clinical empirical study to evaluate the feasibility and effectiveness of precise health education program for PICC patients with catheter, and to observe the impact of this health education model on the knowledge, attitude and practice level of daily management, self-management efficacy and the incidence of related complications after catheter insertion in PICC patients, so as to provide a reference for health education of PICC patients.

Study Overview

• Status: Active, not recruiting
• Conditions: Tumor Chemotherapy Patients
• Intervention / Treatment: Behavioral: Routine health education; Behavioral: Routine health education + precise health education

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250000
      • Qianfoshan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Cancer patients undergoing chemotherapy in our hospital with ≥6 cycles of chemotherapy;
• Patients with PICC implanted for the first time and maintained at our hospital;
• Aged 18-60 years;
• The material and performance of PICC catheter are silicone three-way valve catheter;
• Catheter placement under the guidance of portable color Doppler ultrasound diagnostic instrument;
• Clear consciousness, good language communication skills and normal comprehension ability;
• Informed consent and voluntary participation in the study.

Exclusion Criteria:

• Persons with self-care ability defects;
• Puncture times more than 1 time.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: The control group; The control group received routine health education after catheterization, including introducing the purpose, method, advantages and complications of PICC insertion to patients before catheterization and signing informed consent. During catheterization, PICC assistant explained relevant matters needing attention and cooperative actions to the patient. After catheterization, patients were instructed to carry out grip training and limb activities.	Behavioral: Routine health education; The control group received routine health education after catheterization, including introducing the purpose, method, advantages and complications of PICC insertion to patients before catheterization and signing informed consent. During catheterization, PICC assistant explained relevant matters needing attention and cooperative actions to the patient. After catheterization, patients were instructed to carry out grip training and limb activities.
Experimental: Experimental group; On the basis of routine health education in the control group, the experimental group screened the high-risk behaviors of patients through the questionnaire of daily life behavior habits, and formulated the precise and concrete health education program for their high-risk behaviors	Behavioral: Routine health education + precise health education; On the basis of routine health education in the control group, the experimental group screened the high-risk behaviors of patients through the questionnaire of daily life behavior habits, and formulated the precise and concrete health education program for their high-risk behaviors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of complications associated with PICC catheter	It is determined by PICC specialist nurse/sonographer during each patient maintenance	Six cycles of chemotherapy,Each chemotherapy cycle lasted 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge, attitude and practice score of daily management of patients with PICC tube	Through the results of PICC daily management knowledge, attitude and practice questionnaire, the scores of daily management knowledge, attitude and practice before and after intervention were analyzed and compared between the two groups	Patients before catheterization and after 6 cycles of chemotherapy
Scores of self-management efficacy of patients with PICC tube	Through the results of self-management efficacy questionnaire of patients with PICC tube, the scores of self-management efficacy before and after intervention were analyzed and compared between the two groups.	A total of 6 chemotherapy cycles were observed before catheterization and after each chemotherapy cycle (28 days)
Satisfaction of health education of patients with PICC tube	Through the results of the health education satisfaction questionnaire of patients with PICC tube, the satisfaction of the two groups of patients with health education after intervention was analyzed and compared.	A total of 6 chemotherapy cycles were observed before catheterization and after each chemotherapy cycle (28 days)

Collaborators and Investigators

• Sponsor: Junyan Zhao

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2022
• Primary Completion (Anticipated): January 28, 2023
• Study Completion (Anticipated): March 30, 2023

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Estimate): December 9, 2022

Study Record Updates

• Last Update Posted (Estimate): December 9, 2022
• Last Update Submitted That Met QC Criteria: December 1, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: YXLL-KY-2022(067)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No