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Recruiting NCT06855082

A Study of Using the Stoma Self-care Apps by Patients With Enterostomy

No phase Interventional Enterostomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: stoma self-care apps, Traditional Education Receive colostomy health education manual with oral instruction.
Who it may be relevant to
Registry conditions: Enterostomy. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Study of Using the Stoma Self-care Apps by Patients With Enterostomy on the Integrated Model of Technology Acceptance (TAM) and Task-technology Fit(TTF)

Overview

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.

Detailed description

Background: Self-care for patients after enterostomy surgery includes both cognitive and skill aspects. Insufficient self-care ability, inability to tell self-care precautions, and incorrect steps in performing care skills lead to leakage of the ostomy bag, and 70% of peristomal skin lesions occur. Complications lead to increased hospitalization days, readmission rates, and medical costs. Pain and other discomforts caused by skin complications around the stoma can cause anxiety, depression or anger, followed by financial burdens and impacts on families, affecting the quality of life. Ostomates use paper texts and oral instructions to provide post-enterostomy nursing care instructions. There is no regular follow-up mechanism after discharge. After returning home, enterostomy patients' self-care ability and adaptability to the stoma will be tested. Changes in the defecation outlet after enterostomy surgery affect many aspects. Patients need to relearn daily care. Physically, they need to maintain the cleanliness of the ostomy bag collection system at all times. Their lifestyle must be consistent with postoperative diet and exercise. Changes; psychologically, the changes in body function and appearance, anxiety, depression, or anger caused in the process of adapting to the enterostomy lifestyle, followed by the financial burden and impact on the family, and the physical, mental, and spiritual impact of family members on each other. It is a huge change, providing ongoing care guidance and support to ensure self-care and quality of life after returning home, meeting the constraints faced by patients with enterostomy needs and the challenges faced by their care guidance.

Purpose: 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.

Method: It is a quantitative, single-blind, simple randomly assigned, quasi-experimental study. The surgical ward and stoma treatment room of a medical center in northern Taiwan accepted patients with enterostomy, including 25 patients in the control group and 25 patients in the experimental group. The interventional measures were performed on the first day after enterostomy surgery, using integrated technology to receive and adapt task technology. Model, the enterostomy self-care knowledge scale, and the stoma self-care ability scale (UES) are used to evaluate self-care ability, and the stoma patient quality of life scale (Stoma-QOL) is used to evaluate the quality of life, and a questionnaire survey is conducted. Analyze task technology fit.

Interventions

  • Behavioral stoma self-care apps
    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 i
  • Behavioral Traditional Education Receive colostomy health education manual with oral instruction
    conventional

Primary outcome measures

  • The quality of life of patients with colostomy [Time frame: Day 1 to 28 after colostomy surgery]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Taiwan · 1 center
  • MacKay Memorial Hospital — Taipei

Publications

  • 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 35439075

Identifiers

NCT: NCT06855082 · 24MMHIS457e

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗