NCT04272528

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

September 2, 2021

Status Verified

August 1, 2021

Enrollment Period

1.7 years

First QC Date

December 30, 2019

Last Update Submit

August 31, 2021

Conditions

Surgical Stomas

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Self-care ability measured by stoma self-care ability scale

    6 months

  • Stoma complications

    6 months

Study Arms (2)

experimental group

EXPERIMENTAL

Nurses provide uniform care to patients according to the quality standards.

Other: uniform care

control group

PLACEBO COMPARATOR

Nurses provide the routine care to patients.

Other: conventional care

Interventions

uniform careOTHER

The leader develops training plan and trains nurses, who provide uniform care and education to patients according to the training.

experimental group
conventional careOTHER

Nurses carry out the routine care procedures.

control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • patients with organ dysfunction who have difficulty in self-care;
  • patients with mental illness, consciousness disorder or communication disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Study Officials

  • Xia Xin

    First Affiliated Hospital of Xian Jiaotong University

    STUDY CHAIR

Central Study Contacts

Sijie Chen

CONTACT

0086-173735605621031092940@qq.com

Xiulin Wen

CONTACT

0086-13991893501332919997@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2019

First Posted

February 17, 2020

Study Start

May 1, 2020

Primary Completion

December 31, 2021

Study Completion

August 31, 2022

Last Updated

September 2, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)