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Chat-based Instant Messaging Support Health Education Program

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Chatbot Little K Nurse
Sponsored by
National Taiwan Normal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Kidney Disease focused on measuring Chronic Kidney Disease, Chatbot, Push notification, Users' evaluation

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: adults over 20 years old diagnosed chronic kidney disease the ability to operate technologies intact cognition Exclusion Criteria: Who was undergoing kidney dialysis, unconsciousness, dementia, or any other mental illness.

Sites / Locations

  • National Taiwan Normal University,

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chatbot Little K Nurse

Arm Description

The CKD chat-based instant messaging support health education system in this study was named "Chatbot Little K Nurse" and connected to the Line platform to set up a one-to-one line. K stands for "kidney." Each group contained three parties: patients with CKD (participants ), Chatbot Little K Nurse (virtual), and an instructor (health teacher) for an enhanced intervention. According to the handbook of CKD health management by the Health Promotion Administration (2018b) and the CKD Clinical Diagnosis and Treatment Guidelines for literature investigation in Taiwan, 350 groups of question-and-answer (Q&A) corpora were formed.

Outcomes

Primary Outcome Measures

Chronic kidney disease subjects' health literacy and disease knowledge
A chronic kidney disease specific health literacy and knowledge assessment tool consists of two parts: (1) chronic kidney disease specific health literacy (communicative literacy) and (2) disease knowledge. Participants scored one point for each correct answer and 0 points for wrong answers. A paired sample t-test was used to analyze chronic kidney disease subjects' health literacy (pre-test vs. post-test).
System usability scale was developed to subjectively evaluate the user's operating system to understand and ensure its usability and quality.
The System usability scale consisted of 10 items rated on a Likert-type scale ranging from one (strongly disagree) to five (strongly agree). In this study, items 1-5 and 6-10 were considered positive and negative, respectively. For positive items, we subtracted 1 point and for negative items, we subtracted 5 points from the score of the items. The generalized estimating equation was used to evaluate the change of System usability scale scores at three time points.

Secondary Outcome Measures

Full Information

First Posted
September 22, 2022
Last Updated
December 23, 2022
Sponsor
National Taiwan Normal University
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1. Study Identification

Unique Protocol Identification Number
NCT05665517
Brief Title
Chat-based Instant Messaging Support Health Education Program
Official Title
User Evaluation of a Chat-based Instant Messaging Support Health Education Program for Chronic Kidney Disease: Effectiveness and Gender Differences
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
April 13, 2020 (Actual)
Primary Completion Date
November 2, 2020 (Actual)
Study Completion Date
November 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taiwan Normal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to explore the effectiveness of a CKD-specific chatbot-based instant messaging support health education (CIM-SHE) program and determine its user evaluation by CKD patients. A pre- and post-study design was employed and 60 patients were invited to join a three-month program for chronic kidney disease health education; 55 successfully completed the intervention. Data were collected from April to November, 2020, using a structured questionnaire. Paired t-tests and generalized equation estimation were used to examine the intervention effectiveness and users' evaluation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Chronic Kidney Disease, Chatbot, Push notification, Users' evaluation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
At the first meeting, the participants completed the pre-test of the CKD patient's simple health literacy evaluation and were invited to use the "Chatbot Little K Nurse", which was an intervention of CKD chat-based instant messaging support health education system. After the first week, the first System Usability Scale (SUS) measurement was completed, whereas the second SUS measurement was completed in the fourth week. After completing the intervention in the 12th week, the participant's health literacy was reassessed through a post-test, and the third SUS assessment was performed.
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chatbot Little K Nurse
Arm Type
Experimental
Arm Description
The CKD chat-based instant messaging support health education system in this study was named "Chatbot Little K Nurse" and connected to the Line platform to set up a one-to-one line. K stands for "kidney." Each group contained three parties: patients with CKD (participants ), Chatbot Little K Nurse (virtual), and an instructor (health teacher) for an enhanced intervention. According to the handbook of CKD health management by the Health Promotion Administration (2018b) and the CKD Clinical Diagnosis and Treatment Guidelines for literature investigation in Taiwan, 350 groups of question-and-answer (Q&A) corpora were formed.
Intervention Type
Device
Intervention Name(s)
Chatbot Little K Nurse
Intervention Description
The CKD chat-based instant messaging support health education system in this study was named "Chatbot Little K Nurse" and connected to the Line platform to set up a one-to-one line. K stands for "kidney." Each group contained three parties: patients with CKD (participants ), Chatbot Little K Nurse (virtual), and an instructor (health teacher) for an enhanced intervention. According to the handbook of CKD health management by the Health Promotion Administration (2018b) and the CKD Clinical Diagnosis and Treatment Guidelines for literature investigation in Taiwan, 350 groups of question-and-answer (Q&A) corpora were formed.
Primary Outcome Measure Information:
Title
Chronic kidney disease subjects' health literacy and disease knowledge
Description
A chronic kidney disease specific health literacy and knowledge assessment tool consists of two parts: (1) chronic kidney disease specific health literacy (communicative literacy) and (2) disease knowledge. Participants scored one point for each correct answer and 0 points for wrong answers. A paired sample t-test was used to analyze chronic kidney disease subjects' health literacy (pre-test vs. post-test).
Time Frame
12 weeks
Title
System usability scale was developed to subjectively evaluate the user's operating system to understand and ensure its usability and quality.
Description
The System usability scale consisted of 10 items rated on a Likert-type scale ranging from one (strongly disagree) to five (strongly agree). In this study, items 1-5 and 6-10 were considered positive and negative, respectively. For positive items, we subtracted 1 point and for negative items, we subtracted 5 points from the score of the items. The generalized estimating equation was used to evaluate the change of System usability scale scores at three time points.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adults over 20 years old diagnosed chronic kidney disease the ability to operate technologies intact cognition Exclusion Criteria: Who was undergoing kidney dialysis, unconsciousness, dementia, or any other mental illness.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong-Long Guo, PhD
Organizational Affiliation
National Taiwan Normal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan Normal University,
City
Taipei
ZIP/Postal Code
10610
Country
Taiwan

12. IPD Sharing Statement

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Chat-based Instant Messaging Support Health Education Program

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