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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05665517
Other study ID # 109-E-04
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 13, 2020
Est. completion date November 2, 2020

Study information

Verified date December 2022
Source National Taiwan Normal University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date November 2, 2020
Est. primary completion date November 2, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: 1. adults over 20 years old 2. diagnosed chronic kidney disease 3. the ability to operate technologies 4. intact cognition Exclusion Criteria: Who was undergoing kidney dialysis, unconsciousness, dementia, or any other mental illness.

Study Design


Intervention

Device:
Chatbot Little K Nurse
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.

Locations

Country Name City State
Taiwan National Taiwan Normal University, Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan Normal University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 12 weeks
Primary 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. 12 weeks
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