- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06560671
Compare the Patient Satisfaction and Effectiveness After Novel Application-based or Conventional Health Education of Bowel Preparation for Colonoscopy
Compare the Patient Satisfaction and Effectiveness After Novel Application-based or Conventional Health Education of Bowel Preparation for Colonoscopy-- Randomized Controlled Trial
Colorectal cancer is the cancer with highest incidence in Taiwan. The disease itself and subsequent treatment cause huge impact on the physical, psychological, and spiritual parts and social role of a patient. Early diagnosis of colorectal cancer and precancerous lesions is possible. Early treatment can reduce the impact on quality of life and economics.
Colonoscopy is an important tool for diagnosis of colorectal proliferative lesions. Qualified bowel preparation can enhance sensitivity and reduce false negative of the colonoscopy. However, multiple factors influence the quality of bowel preparation. This study aims to investigate whether the animation video and game-based health education is more effective and satisfying than conventional health education, and to explore the difference of knowledge dissemination and quality of bowel preparation between novel and conventional methods.
This study is a randomized controlled trial and uses structural questionnaire for study participants. Before the main study, the investigators will consult professors' opinions to adjust and enhance validity of the questionnaire, and the investigators will perform pretest to calculate its reliability. The investigators will enroll participants at the out-patient-department and the health management center. Questionnaires may be completed by on-site paper or phone with internet resources. The main participants of this study are adults aged 18 and more, and planned to receive colonoscopy. The questionnaires investigate the spent time, patient satisfaction, knowledge of bowel preparation and results of colonoscopy of different approaches of health education. Multiple linear regression will be applied to calculate the possible significance difference between two kinds of health education.
The investigators expect this study (1) to explore whether novel health education enhances patient satisfaction (2) to investigate the efficiency of novel health education, and (3) to compare the effect of knowledge dissemination and quality of bowel preparation between experimental and control groups. This study will develop the model of health education to facilitate holistic health care.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mingchih Liu, MD
- Phone Number: 523753 +886-35326151
- Email: 010871ster@gmail.com
Study Locations
-
-
-
Hsinchu, Taiwan, 300
- Recruiting
- National Taiwan University HsinChu Branch
-
Contact:
- Mingchih Liu, MD
- Phone Number: 523753 +886-35326151
- Email: 010871ster@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- adults planned to accept colonoscopy exam
Exclusion Criteria:
- can't accept health education or refuse follow-up
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Conventional
|
animation video based health education
|
|
Experimental: Novel
|
animation video based health education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
quality of bowel preparation
Time Frame: immediately after the procedure of colonoscopy
|
cleansing level of Aronchick scale 1-4
|
immediately after the procedure of colonoscopy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
satisfaction of health education
Time Frame: immediately after the intervention of health education
|
5 points Likert scale
|
immediately after the intervention of health education
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mingchih Liu, MD, National Taiwan University Hospital HsinChu Branch
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202310047RINB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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