NCT06855082

Brief Summary

This study uses a stoma self-care app, accessed through LINE official account, a communication software commonly used by Chinese people, as an intervention measure to integrate technology acceptance and task technology adaptation models to explore the correlation of each aspect and its impact on self-care ability and quality of life. Whether the factors and task technology adaptability will affect the willingness and usage behavior of enterostomy patients, the research subjects can effectively improve their self-care ability, quality of life, usage willingness, and usage behavior after intervention.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress62%
Mar 2025Jan 2027

First Submitted

Initial submission to the registry

February 14, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 3, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

March 14, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2027

Last Updated

May 7, 2025

Status Verified

May 1, 2025

Enrollment Period

1.8 years

First QC Date

February 14, 2025

Last Update Submit

May 4, 2025

Conditions

Keywords

Enterostomystoma self-care appsTechnology Acceptance ModelTask Technology Fit Model

Outcome Measures

Primary Outcomes (1)

  • The quality of life of patients with colostomy

    The Stoma-QOL scale was used to measure the quality of life. The score was scored on a 4-point scale ranging from 30 to 120 points. The higher the score, the better the quality of life of the research subjects.

    Day 1 to 28 after colostomy surgery

Study Arms (2)

stoma self-care apps

EXPERIMENTAL

uses a stoma self-care app, accessed through LINE official account, a communication software commonly used by Chinese people, as an intervention measure to integrate technology acceptance and task technology adaptation models to explore the correlation of each aspect and its impact on self-care ability and quality of life.

Behavioral: stoma self-care apps

conventional

PLACEBO COMPARATOR

conventional Traditional Education

Behavioral: Traditional Education Receive colostomy health education manual with oral instruction

Interventions

This study uses a stoma self-care app, accessed through LINE official account, a communication software commonly used by Chinese people, as an intervention measure to integrate technology acceptance and task technology adaptation models to explore the correlation of each aspect and its impact on self-care ability and quality of life. Whether the factors and task technology adaptability will affect the willingness and usage behavior of enterostomy patients, the research subjects can effectively improve their self-care ability, quality of life, usage willingness, and usage behavior after intervention.

stoma self-care apps

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with colorectal cancer or intestinal obstruction or abdominal trauma, those who have received colostomy during this hospitalization
  • Conscious, can communicate in Mandarin or Minnan dialect
  • Have no communication, vision, or hearing impairments,
  • Have smartphones

You may not qualify if:

  • Those who are unable to cooperate due to visual, hearing, cognitive or mental impairments
  • Patients who need colostomy surgery due to non-colorectal cancer, intestinal obstruction, or abdominal trauma
  • Patients diagnosed by a physician as having surgery-related complications and requiring further surgery, such as infection, intestinal Perforation, stoma prolapse, stenosis, necrosis, bleeding, etc. (IV) Those who are unable to learn self-care on the day before discharge due to worsening of their illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MacKay Memorial Hospital

Taipei, 104, Taiwan

RECRUITING

Related Publications (1)

  • Martins L, Down G, Andersen BD, Nielsen LF, Hansen AS, Herschend NO, Storling Z. The Ostomy Skin Tool 2.0: a new instrument for assessing peristomal skin changes. Br J Nurs. 2022 Apr 21;31(8):442-450. doi: 10.12968/bjon.2022.31.8.442.

    PMID: 35439075BACKGROUND

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Central Study Contacts

MING HSIANG TU

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Technology Acceptance Model, TAM Task Technology Fit Model, TTF
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Surgical Ward RN

Study Record Dates

First Submitted

February 14, 2025

First Posted

March 3, 2025

Study Start

March 14, 2025

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

January 15, 2027

Last Updated

May 7, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations