NCT05665517

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 13, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2020

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 27, 2022

Completed
Last Updated

December 27, 2022

Status Verified

December 1, 2022

Enrollment Period

7 months

First QC Date

September 22, 2022

Last Update Submit

December 23, 2022

Conditions

Keywords

Chronic Kidney DiseaseChatbotPush notificationUsers' evaluation

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

Chatbot Little K Nurse

EXPERIMENTAL

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.

Device: Chatbot Little K Nurse

Interventions

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.

Chatbot Little K Nurse

Eligibility Criteria

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

You may qualify if:

  • adults over 20 years old
  • diagnosed chronic kidney disease
  • the ability to operate technologies
  • intact cognition

You may not qualify if:

  • Who was undergoing kidney dialysis, unconsciousness, dementia, or any other mental illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan Normal University,

Taipei, 10610, Taiwan

Location

Related Publications (1)

  • Chen NJ, Huang CM, Fan CC, Lu LT, Lin FH, Liao JY, Guo JL. User Evaluation of a Chat-Based Instant Messaging Support Health Education Program for Patients With Chronic Kidney Disease: Preliminary Findings of a Formative Study. JMIR Form Res. 2023 Sep 19;7:e45484. doi: 10.2196/45484.

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jong-Long Guo, PhD

    National Taiwan Normal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor

Study Record Dates

First Submitted

September 22, 2022

First Posted

December 27, 2022

Study Start

April 13, 2020

Primary Completion

November 2, 2020

Study Completion

November 2, 2020

Last Updated

December 27, 2022

Record last verified: 2022-12

Locations