Construction and Evaluation of a Stoma Patient Continuous Care Network

Construction and Evaluation a Network Platform of Continuous Care for Ostomy Patients

Construct a professional network platformof continuous care for patients with enterostomy and evaluate its availability， Eventually, patients with enterostomy will have access to care outside the hospital.

Study Overview

• Status: Recruiting
• Conditions: Surgical Stomas
• Intervention / Treatment: Other: professional care; Other: coventional care

Detailed Description

The project to establish a professional care network for stomas patient will be conducted at first Affiliated Hospital Xi'an Jiaotong University.This network platform that patients can enjoy to make an appointment, video interrogation, the inspection booking, self management, health education, and other health and extension services;nursing staff can undertake colostomy online learning and assessment of the relevant knowledge and skills;professional colostomy care is published to provide remote guidance.the efficacy of the network was evaluated by investigating complications rate,and their self-care ability,quality of life, and medical expenses,and patients'satisfaction.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jingrong Wang; Phone Number: 0086-17629259023; Email: 350672758@qq.com
• Study Contact Backup: Name: Xiulin Wen; Phone Number: 0086-13991893501; Email: wenxiulin1981@qq.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Recruiting
      • First Affiliated Hospital Xi'an Jiaotong University
      • Contact: Xiulin Wen; Phone Number: 0086-13991893501; Email: wenxiulin1981@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients aged≥18 years old;
• patients undergoing enterostomy;
• patients possess a smart phone and know how to use it;
• patients volunteer to participate in the survey.

Exclusion Criteria:

• patients have a history of mental disorders;
• cancer has metastasized to other organs, or there are other serious physical diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: experiment group; Nurses provide web-based continuous care to patients.	Other: professional care; The trained nurses provide professional care for the patients.
Other: contral group; Nurses provide the routine care to patients.	Other: coventional care; nurses provide coventional care for the patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
stomy Quality of Life,Stoma-QOL	The scale includes 20 items with a score ranging from 20 to 80points.The higher the score,the better the quality of life.	up to 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enterostomy Patients Self-management Questionnaire	The scale includes 5 dimensions,30items;The higher the score,the better the Self-management.	up to 9 months
Stoma and surrounding complications	Stoma complications include infection around the stoma,skin and mocous membrane separation, hemorrhage etal.	up to 9 months

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Investigators: Study Chair: Xiulin Wen, First Affiliated Hospital of Xian Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: December 20, 2020
• First Submitted That Met QC Criteria: December 20, 2020
• First Posted (Actual): December 23, 2020

Study Record Updates

• Last Update Posted (Actual): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: XJTU1AF2020LSK-228

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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