NCT04682028

Brief Summary

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.

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
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

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 20, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 23, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 10, 2022

Status Verified

August 1, 2021

Enrollment Period

11 months

First QC Date

December 20, 2020

Last Update Submit

May 9, 2022

Conditions

Surgical Stomas

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Enterostomy Patients Self-management Questionnaire

    up to 9 months

  • Stoma and surrounding complications

    up to 9 months

Study Arms (2)

experiment group

OTHER

Nurses provide web-based continuous care to patients.

Other: professional care

contral group

OTHER

Nurses provide the routine care to patients.

Other: coventional care

Interventions

professional careOTHER

The trained nurses provide professional care for the patients.

experiment group
coventional careOTHER

nurses provide coventional care for the patients.

contral 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 possess a smart phone and know how to use it;
  • patients volunteer to participate in the survey.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

first Affiliated Hospital Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Study Officials

  • Xiulin Wen

    First Affiliated Hospital of Xian Jiaotong University

    STUDY CHAIR

Central Study Contacts

Jingrong Wang

CONTACT

0086-17629259023350672758@qq.com

Xiulin Wen

CONTACT

0086-13991893501wenxiulin1981@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 20, 2020

First Posted

December 23, 2020

Study Start

December 1, 2021

Primary Completion

November 1, 2022

Study Completion

December 31, 2022

Last Updated

May 10, 2022

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)