Chronic Kidney DiseaseNCT05665517
Chat-based Instant Messaging Support Health Education Program
A study testing Chatbot Little K Nurse in people with Chronic Kidney Disease, run by National Taiwan Normal University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Chatbot Little K Nurse
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Apr 2020to 2 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults over 20 years old
- diagnosed chronic kidney disease
- the ability to operate technologies
- intact cognition
Who cannot join
- Who was undergoing kidney dialysis, unconsciousness, dementia, or any other mental illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: User Evaluation of a Chat-based Instant Messaging Support Health Education Program for Chronic Kidney Disease: Effectiveness and Gender Differences
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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Chatbot Little K Nurse
- Keywords
- Chronic Kidney Disease, Chatbot, Push notification, Users' evaluation
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chatbot Little K NurseDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Chatbot Little K Nurse |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start13 Apr 2020
- Primary completion2 Nov 2020
- Study completion2 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong-Long Guo, National Taiwan Normal University
- Investigators
- Jong-Long Guo, PhD, Principal investigator, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665517
- Sponsor's protocol ID
- 109-E-04
- Status last verified
- Dec 2022
- First submitted
- 22 Sep 2022
- Last updated
- 27 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37725429
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User Evaluation of a Chat-based Instant Messaging Support Health Education Program for Chronic Kidney Disease: Effectiveness and Gender Differences
- ClinicalTrials.gov ID
- NCT05665517
- Acronym / sponsor ID
- 109-E-04
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease, Chatbot, Push notification, Users' evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- National Taiwan Normal UniversityUniversity, hospital or other
- Study start
- 13 Apr 2020 (actual)
- Primary completion
- 2 Nov 2020 (actual)
- Study completion
- 2 Nov 2020 (actual)
- First posted
- 27 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Chatbot Little K Nurse | Experimental | Device: Chatbot Little K NurseThe 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adults over 20 years old
- diagnosed chronic kidney disease
- the ability to operate technologies
- intact cognition
Key exclusion criteria (1 listed)
- Who was undergoing kidney dialysis, unconsciousness, dementia, or any other mental illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chatbot Little K NurseThe 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 |
Primary outcome
Chronic kidney disease subjects' health literacy and disease knowledge
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
- Derived from this study: PubMed 37725429Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong-Long Guo, PhD principal investigator
National Taiwan Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chatbot Little K Nurse in people with Chronic Kidney Disease, run by National Taiwan Normal University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic kidney disease subjects' health literacy and disease knowledge (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05665517, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2022.