AzTrials
AzTrials

Clinical CompetenceCALMONCT06780228

Evaluation of a Chatbot With CALMO (Chatbot-Assisted Learning Model) to Enhance Clinical Learning in Nursing Students

A study testing chatbot-assisted clinical learning in people with Clinical Competence, run by Caritas Institute of Higher Education.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The present proposed study will design and develop a chatbot to support graduating nursing students' clinical learning. The efficacy of this chatbot technology will be evaluated, using a mixed methods quasi-experimental design. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Clinical Competence
What is being tested?
chatbot-assisted clinical learning
Could I receive a placebo?
No, everyone receives an active treatment
How many people
174 participants
Where
No sites listed yet
Study dates
11 Jan 2025to 30 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Baccalaureate nursing students participating in their final clinical placement
  • have sufficient knowledge of English language
  • own a smartphone with internet access
  • possess a valid Hong Kong phone number
  • possess a valid email address

Who cannot join

  • those who have been involved in the pilot test of the proposed chatbot intervention

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Winnie LS CHENG, PhD contact

852-37024434

wcheng@sfu.edu.hk

About this study

Official title: Development and Evaluation of a Chatbot With CALMO to Enhance Clinical Learning in Nursing Students: A Quasi-Experimental Mixed-Methods Study

The present proposed study will design and develop a chatbot to support graduating nursing students' clinical learning. The efficacy of this chatbot technology will be evaluated, using a mixed methods quasi-experimental design. the proposed study hypothesizes that the chatbot-assisted clinical education has the potential to promote clinical performance by improving nursing knowledge, general self-efficacy, and self-reflection and insight.

Read the detailed description

The present proposed study will design and develop a chatbot to support graduating nursing students' clinical learning. The objectives of the proposed study are: (1) Design and develop a chatbot prototype that can simulate conversations, provide clinical information, and offer guidance relevant to various clinical scenarios; (2) Evaluate the impact of the chatbot intervention on nursing students' nursing knowledge, general self-efficacy, and self-reflection and insight; (3) Explore students' perceptions, satisfaction, and acceptance of the chatbot as an educational tool.The efficacy of this chatbot technology will be evaluated, using a mixed methods quasi-experimental design. the proposed study hypothesizes that the chatbot-assisted clinical education has the potential to promote clinical performance by improving nursing knowledge, general self-efficacy, and self-reflection and insight. The proposed study will be conducted in two phases. Phase 1: Design and develop a chatbot prototype which can provide evidence-based clinical information, engaging in interactive dialogue, and offering learning resources tailored to different clinical scenarios. The chatbot will be accessible through a web-based platform or mobile application. Phase 2: Conduct a mixed-methods quasi-experimental design and focus group interviews to evaluate the impact of the chatbot intervention on clinical learning. A convenience sample of 174 nursing students enrolled in a nursing program from two institutions will be recruited and assigned to either the experimental group, which will receive chatbot-supported clinical learning, or the control group, which will receive traditional clinical education without chatbot integration. Quantitative data will be collected from the two groups at three-time points: before-intervention at baseline (T0), 4 weeks after baseline (week 4, T1) and after intervention (week 12; T2) to assess students' nursing knowledge, general self-efficacy, and self-reflection and insight. Qualitative data will be collected through focus group interviews to explore students' perceptions, satisfaction, and experiences with chatbot-assisted learning. Quantitative data will be analyzed using MANOVA to compare the outcomes between and within groups. Thematic analysis will be conducted for qualitative data to identify emerging themes and patterns related to student perceptions and experiences using chatbot. Participants in the Experimental Group (EG) will receive an access code for the self-developed web-based chatbot platform called CALMO, a gender-neutral name as an acronym for Chatbot-Assisted Learning Model, which is planned to be developed during the first phase of this proposed study. The intervention will be available throughout the 12-week study.Participants in the Control Group (CG) will receive their usual clinical education support during the intervention period.A project management team will be formed to evaluate the intervention and ensure the quality and consistency of study intervention via regular face-to-face or online meetings. The fidelity of the study will be ensured by developing mechanisms for tracking participant logins, session completion rates, and engagement with intervention materials. Regular checks of the chatbot functionality will be performed by the platform developer with provision of regular service reports. Communication channels will be established for participants to provide feedback, report technical issues, or seek support from the research team during the intervention. Data will be analyzed using a mixed-methods approach, combining both quantitative and qualitative data. The statistical analysis using Statistical Package for the Social Sciences (SPSS), Version 26. The baseline characteristics of the participants in the two arms will be compared to identify any clinically meaningful differences using Chi-square test (for nominal data), Mann-Witney U test (for ordinal or non-normality data) or t-test (for normality data). Any variables considered to be significantly different will be further evaluated (e.g., included as covariates in the statistical analyses) and adjusted to account for their potential confounding effects on the outcomes. To test the hypothesis and to cater for the clustering effect with repeated measures of the outcome variables, a multivariate approach, such as a Generalized Estimating Equation (GEE), with adjustment of the baseline outcome variables to test for between-group differences will be employed. If students drop out between baseline and final data collection, intention to treat analysis will be applied. Both the Time x Group effect will be tested using a two-sided type I error rate of 5% for all tests of significance. Thematic analysis will be conducted for qualitative data to identify emerging themes and patterns related to students' perceptions and experiences.

Being tested
chatbot-assisted clinical learning
Keywords
Clinical learning, Nursing students, Chatbot, Focus group interview, Quasi-experimental design

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • chatbot-assisted clinical learningBehavioural

    The participants will recevie a self-developed web-based chatbot platform which is accessible via smartphones. It provides real-time dialogue with the chatbot through texts, visual aids, and audio files. The intervention will be available throughout the 12-week study. the chatbot is characterized by a gender-neutral persona, assumes the role of a friendly and empathetic clinical mentor. Its communication style can be described as calm, tolerant, supportive, and appreciative. Participants will receive weekly SMS notifications to remind them to consult with the chatbot.

Study groups in NCT06780228
Study groupRoleWhat they receive
Chatbot assisted learningExperimentalThe participants will recevie a self-developed web-based chatbot platform which is accessible via smartphones. It provides real-time dialogue with the chatbot through texts, visual aids, and audio files. The intervention will be available throughout the 12-week study. the chatbot is characterized by a gender-neutral persona, assumes the role of a friendly and empathetic clinical mentor. Its communication style can be described as calm, tolerant, supportive, and appreciative. Participants will receive weekly Short Message Service (SMS) notifications to remind them to consult with the chatbot.
Receives: Behavioral: chatbot-assisted clinical learning
control group _usual careNo interventionParticipants in the Control Group will receive their usual clinical education support during the intervention period

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. nursing knowledge

    multiple-choice questionnaire (MCQ) consisting of 50 items will be administered to evaluate students' nursing knowledge. the score ranges from 0 to 50. the higher the score, the better nursing knowledge.

    Measured: before-intervention at baseline (T0), 4 weeks after baseline (week 4, T1) and after intervention (week 12; T2).

  2. General self-efficacy

    A 10-item General Self-Efficacy Scale to assess a general sense of perceived self-efficacy to manage hassles. It is scored with possible responses, 1=not at all true; 2=hardly true; 3=moderately true; and 4=exactly true, yielding a total score between 10 and 40. The higher the score, the higher the optimistic to cope with daily hassles.

    Measured: before-intervention at baseline (T0), 4 weeks after baseline (week 4, T1) and after intervention (week 12; T2).

Secondary outcomes (2)
  1. Self-reflection and insight

    A 12-item Self-Reflection and Insight Scale to assess the need for self-reflection and engagement in self-reflection. The scale is scored from 6 (highly matched) to 1 (least matched), yielding a total score between 12 and 72. Higher scores indicated greater self-reflection and insight.

    Measured: : before-intervention at baseline (T0), 4 weeks after baseline (week 4, T1) and after intervention (week 12; T2).

  2. Qualitative Comments on the Perceptions of Chatbot-assisted technology

    it is a narrative feedback from the participants using focus group interviews to explore users' experiences with the chatbot during their clinical learning. A set of semi-structured interview questions encompassing questions to describe the overall experience, identify useful features, and assess the impact on understanding and retention of clinical concepts. Usability and user-friendliness of the chatbot interface will also be evaluated. For example: Can you describe your experience using the chatbot for clinical learning? What specific features or functionalities did you find useful or engaging? How do you think the chatbot has contributed to your understanding and retention of clinical concepts? Are there any limitations or challenges you encountered while using the chatbot? Did you perceive any differences in your learning outcomes when using the chatbot compared to other learning methods or resources? If so, what were those differences?

    Measured: at the end of the 12-week study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2025
  2. Study start11 Jan 2025 (estimated)
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

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
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
174 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06780228
Sponsor's protocol ID
ISG230111
Acronym
CALMO
Status last verified
Jan 2025
First submitted
11 Jan 2025
Last updated
17 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: I will not publish in Medical Journal Editors

Questions about this trial

What is this clinical trial studying?

A study testing chatbot-assisted clinical learning in people with Clinical Competence, run by Caritas Institute of Higher Education.

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 5 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: opening soon, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Winnie LS CHENG, PhD (852-37024434, wcheng@sfu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

nursing knowledge (time frame: before-intervention at baseline (T0), 4 weeks after baseline (week 4, T1) and after intervention (week 12; T2).). 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?
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 17 Jan 2025.

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