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

Sponsor
Junyan Zhao (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05643937
Collaborator
(none)
140
1
2
8
17.4

Study Details

Study Description

Brief Summary

  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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Routine health education
  • Behavioral: Routine health education + precise health education
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Construction and Application of Precise Health Education Model for Patients With PICC Tube
Actual Study Start Date :
Jul 28, 2022
Anticipated Primary Completion Date :
Jan 28, 2023
Anticipated Study Completion Date :
Mar 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Incidence of complications associated with PICC catheter [Six cycles of chemotherapy,Each chemotherapy cycle lasted 28 days]

    It is determined by PICC specialist nurse/sonographer during each patient maintenance

Secondary Outcome Measures

  1. Knowledge, attitude and practice score of daily management of patients with PICC tube [Patients before catheterization and after 6 cycles of chemotherapy]

    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

  2. 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)]

    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.

  3. 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)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Qianfoshan Hospital Jinan Shandong China 250000

Sponsors and Collaborators

  • Junyan Zhao

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Junyan Zhao, Principal investigator, Qianfoshan Hospital
ClinicalTrials.gov Identifier:
NCT05643937
Other Study ID Numbers:
  • YXLL-KY-2022(067)
First Posted:
Dec 9, 2022
Last Update Posted:
Dec 9, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Dec 9, 2022