Construction and Evaluation of a Stoma Patient Care Network

Surgical Stomas Clinical Trial

Official title:

Construction and Evaluation of a Uniform Stoma Patient Care Network in Shaanxi Province

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04272528
• Other study ID #: 2019SF-124
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: August 31, 2022

Study information

• Verified date: August 2021
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Sijie Chen
• Phone: 0086-17373560562
• Email: 1031092940[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Establish a uniform care network for stoma patients in Shaanxi Province and evaluate its effectiveness, so that stoma patients can get the same quality of stoma care outside the hospital.

Description:

This project plans to take the First Affiliated Hospital of Xi'an Jiaotong University as the lead hospital to establish a uniform care network for stoma patients in Shaanxi Province. This network includes the management system of stoma nursing and the management organization of stoma patients in Shaanxi Province. It formulates the whole quality standard of stoma nursing in Shaanxi Province, carries out "standard training" for the stoma specialty nurses in the group, and carries out on-site inspection in various hospitals from time to time, establishes the feedback mechanism and standardizes the stoma nursing process. The contact card of stoma therapists was made and distributed to patients with stoma, so that patients can easily get the information of stoma therapists in the nearest hospital and receive professional and convenient care. WeChat group of specialized stoma nurses was established to provide remote guidance for difficult cases, share new stoma ideas and knowledge, and facilitate communication among stoma nurses in the group. The leading hospital holds training courses on knowledge and progress of stomatology every year, competitions on knowledge and skills, and dispatches therapists to provide work guidance, so as to share new knowledge, skills and scientific research abilities. At the same time, the efficacy of the network was evaluated by investigating the complication rate, self-care ability, quality of life, medical costs of stoma patients,as well as the specialized nursing skills and professional development of nurses.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: August 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients aged =18 years old;

• patients undergoing enterostomy;

• patients with primary school and above education level;

• patients with clear consciousness, reading and verbal expression ability;

• patients could reexamine regularly;

• patients informed consent and voluntary participation in the study.

Exclusion Criteria:

• patients with organ dysfunction who have difficulty in self-care;

• patients with mental illness, consciousness disorder or communication disorder.

Related Conditions & MeSH terms

• Surgical Stomas

Intervention

Other:
• uniform care
The leader develops training plan and trains nurses, who provide uniform care and education to patients according to the training.
• conventional care
Nurses carry out the routine care procedures.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xian Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life measured by Stoma Quality of Life (Stoma-QOL).	The scale includes 20 items with a score ranging from 20 to 80 points. The higher the score, the better the quality of life.	6 months
Secondary	Self-care ability measured by stoma self-care ability scale	The scale includes three dimensions: self intention questionnaire (12-48 points), self-care knowledge (0-21 points), self-care skills (0-12 points). The higher the score, the higher the self-care ability.	6 months
Secondary	Stoma complications	Stoma complications include infection around the stoma,parastomal hernia,skin and mucous membrane separation,fistula of stoma,hemorrhage,ischemia,and stenosis.	6 months