NCT05643937

Brief Summary

  1. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 28, 2022

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 9, 2022

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

February 3, 2023

Status Verified

February 1, 2023

Enrollment Period

5 months

First QC Date

August 24, 2022

Last Update Submit

February 2, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Knowledge, attitude and practice score of daily management of patients with PICC tube

    Patients before catheterization and after 6 cycles of chemotherapy

  • Scores of self-management efficacy of patients with PICC tube

    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

    A total of 6 chemotherapy cycles were observed before catheterization and after each chemotherapy cycle (28 days)

Study Arms (2)

The control group

ACTIVE COMPARATOR

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

Experimental group

EXPERIMENTAL

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

Interventions

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.

The control 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

Experimental group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qianfoshan Hospital

Jinan, Shandong, 250000, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 24, 2022

First Posted

December 9, 2022

Study Start

July 28, 2022

Primary Completion

December 28, 2022

Study Completion

January 30, 2023

Last Updated

February 3, 2023

Record last verified: 2023-02

Locations