MigraineNCT06920602
AI Chatbot for Migraine Management in Hong Kong Women
A study testing AI-empowered voice-interactive chatbot and Paper migraine diary in people with Migraine, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The goal of this randomized crossover trial is to examine whether the AI-empowered chatbot will effectively collect comprehensive migraine feature data and demonstrate higher compliance, accuracy, utilization, acceptability, feasibility, and validity in migraine feature tracking compared to traditional paper-based… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Migraine
- What is being tested?
- AI-empowered voice-interactive chatbot and Paper migraine diary
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2025to 1 Nov 2025
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18 years or older
- Meet diagnostic criteria for migraine according to ICHD-3
- Experiencing at least 2 headache days per month
- Living in Hong Kong
- Fluent in Cantonese
- Owning a smartphone with internet access
- Willing to provide informed consent
Who cannot join
- Individuals with severe cognitive impairments or communication difficulties
- Those unable to use a smartphone or the chatbot due to physical or mental limitations
- Using another alternative electronic migraine diary during recruitment or in the past 12 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Evaluation of an AI-empowered Voice-interactive Chatbot for Migraine Management Among Hong Kong Women: a Randomized Crossover Trial
The goal of this randomized crossover trial is to examine whether the AI-empowered chatbot will effectively collect comprehensive migraine feature data and demonstrate higher compliance, accuracy, utilization, acceptability, feasibility, and validity in migraine feature tracking compared to traditional paper-based migraine diaries among Hong Kong women with migraine.
Participants will use different tools (AI-empowered voice-interactive chatbot or paper migraine diary) for migraine tracking. Participants will be randomly allocated to one of two intervention sequences: (1) AI-empowered voice-interactive chatbot followed by paper migraine diary, or (2) paper migraine diary followed by AI-empowered voice-interactive chatbot. The study will consist of two intervention periods, each lasting one month, with a 1:1 allocation ratio.
- Conditions
- Migraine
- Being tested
- AI-empowered voice-interactive chatbot, Paper migraine diary
- Keywords
- migraine, RCT, migraine diary, artificial intelligence, chatbot
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-empowered voice-interactive chatbotDevice
Participants will interact with the chatbot on a daily basis to record their migraine experiences. They will be asked to initiate a conversation with the chatbot whenever they experience a migraine attack and provide the required information, including the date and time of the attack, presence of aura, migraine intensity, accompanying symptoms, triggers, and medication use. The chatbot will engage participants in a conversation to collect these data points and store them securely within the chatbot system.
Paper migraine diaryDevice
Participants will manually document their migraine experiences on the paper migraine diary, including the date and time of the attack, presence of aura, migraine intensity, accompanying symptoms, triggers, and medication use.
Paper migraine diaryDevice
Participants will manually document their migraine experiences on the paper migraine diary, including the date and time of the attack, presence of aura, migraine intensity, accompanying symptoms, triggers, and medication use.
AI-empowered voice-interactive chatbotDevice
Participants will interact with the chatbot on a daily basis to record their migraine experiences. They will be asked to initiate a conversation with the chatbot whenever they experience a migraine attack and provide the required information, including the date and time of the attack, presence of aura, migraine intensity, accompanying symptoms, triggers, and medication use. The chatbot will engage participants in a conversation to collect these data points and store them securely within the chatbot system.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | AI-empowered voice-interactive chatbot followed by paper migraine diary Receives: Device: AI-empowered voice-interactive chatbot; Device: Paper migraine diary |
| Sequence 2 | Experimental | Paper migraine diary followed by AI-empowered voice-interactive chatbot Receives: Device: Paper migraine diary; Device: AI-empowered voice-interactive chatbot |
What is being measured
The primary outcome is the main question the study is designed to answer.
timeliness
Timeliness will be defined as the proportion of migraine episodes recorded within 24 hours of onset. This measure will be derived from the data collected through the chatbot and paper diary.
Measured: At the end of each 1-month intervention period
Completeness
Completeness will be defined as the proportion of diary entries with all required migraine-related information fully recorded. This measure will be derived from the data collected through the chatbot and paper diary.
Measured: At the end of each 1-month intervention period
Missed episodes
Missed episodes will be defined as the proportion of migraine episodes not recorded; the number of missed episodes in each period will be obtained at the end-of-period questionnaire
Measured: At the end of each 1-month intervention period
Accuracy
Accuracy will be defined as the proportion of diary entries in which all required migraine-related fields were recorded correctly. Accuracy will be adjudicated by assessing the consistency between migraine features recorded using the chatbot or paper diary and those reported during end-of-period online interviews with study staff. Discrepancies will be documented; records will be not altered for primary analyses. During these interviews, researchers will summarise the participant's recorded migraine information for that period, regardless of modality, and ask the participant to identify any errors.
Measured: At the end of each 1-month intervention period
Secondary outcomes (5)
Utilization
Utilization will be evaluated using the Chinese version of the System Usability Scale (SUS), a widely used and validated 10-item questionnaire that assesses the usability of a system on a 5-point Likert scale. The SUS yields a single score ranging from 0 to 100, with higher scores indicating better usability. Specifically, chatbot utilization will be objectively assessed using system-generated data, such as the number of logins, user-initiated conversations, and user responses.
Measured: At the end of each 1-month intervention period
Acceptability
Acceptability will be measured using the validated Chinese version of Technology Acceptance Model (TAM) scale, an 11-item questionnaire on a 7-point Likert scale with higher scores indicating greater acceptance.
Measured: At the end of each 1-month intervention period
Usage
Usage will be assessed by the number of uses (entries) per tool.
Measured: At the end of each 1-month intervention period
Time per recording
Time required to record each migraine episode, using system-logged durations for the chatbot and self-recorded start and finish times for the paper diary.
Measured: At the end of each 1-month intervention period
Validity
The validity of the migraine data collected through the chatbot and paper diary will be assessed using convergent validity and divergent validity. Convergent validity will be evaluated by examining the correlation between migraine frequency and severity recorded using the chatbot or paper diary and the Chinese version of the Migraine Disability Assessment (MIDAS) scores (0 to 270, higher scores indicating greater migraine-related disability). Divergent validity will be assessed by analyzing the correlation between migraine frequency and severity and the Chinese version of the Brief Self-Control Scale (7 to 35, with a higher score indicating greater self-control).
Measured: At the end of each 1-month intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 Jul 2025
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Nethersole Institute of Continuing Holistic Health Education (NICHE)
- Responsible party
- Principal investigator, XIE Yao Jie Grace, The Hong Kong Polytechnic University
- Investigators
- Yao Jie Xie, PhD, Principal investigator, The Hong Kong Polytechnic Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920602
- Sponsor's protocol ID
- HSEARS20241015007
- Other IDs
- RG2024/2025_A_11
- Status last verified
- Apr 2025
- First submitted
- 10 Mar 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of an AI-empowered Voice-interactive Chatbot for Migraine Management Among Hong Kong Women: a Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT06920602
- Acronym / sponsor ID
- HSEARS20241015007
- Conditions
- Migraine
- Keywords
- migraine, RCT, migraine diary, artificial intelligence, chatbot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Nethersole Institute of Continuing Holistic Health Education (NICHE)
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 10 Apr 2025 (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 goal of this randomized crossover trial is to examine whether the AI-empowered chatbot will effectively collect comprehensive migraine feature data and demonstrate higher compliance, accuracy, utilization, acceptability, feasibility, and validity in migraine feature tracking compared to traditional paper-based migraine diaries among Hong Kong women with migraine.
Participants will use different tools (AI-empowered voice-interactive chatbot or paper migraine diary) for migraine tracking. Participants will be randomly allocated to one of two intervention sequences: (1) AI-empowered voice-interactive chatbot followed by paper migraine diary, or (2) paper migraine diary followed by AI-empowered voice-interactive chatbot. The study will consist of two intervention periods, each lasting one month, with a 1:1 allocation ratio.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Device: AI-empowered voice-interactive chatbot, Device: Paper migraine diaryAI-empowered voice-interactive chatbot followed by paper migraine diary |
| Sequence 2 | Experimental | Device: Paper migraine diary, Device: AI-empowered voice-interactive chatbotPaper migraine diary followed by AI-empowered voice-interactive chatbot |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women aged 18 years or older
- Meet diagnostic criteria for migraine according to ICHD-3
- Experiencing at least 2 headache days per month
- Living in Hong Kong
- Fluent in Cantonese
Key exclusion criteria (3 listed)
- Individuals with severe cognitive impairments or communication difficulties
- Those unable to use a smartphone or the chatbot due to physical or mental limitations
- Using another alternative electronic migraine diary during recruitment or in the past 12 weeks
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 |
|---|---|---|
| AI-empowered voice-interactive chatbotParticipants will interact with the chatbot on a daily basis to record their migraine experiences. They will be asked to initiate a conversation with the chatbot whenever they experience a migraine attack and provide the required information, including the date and time of the attack, presence of aura, migraine intensity, accompanying symptoms, triggers, and medication use. The chatbot will engage participants in a conversation to collect these data points and store them securely within the chatbot system. | Device | Sequence 1 |
| Paper migraine diaryParticipants will manually document their migraine experiences on the paper migraine diary, including the date and time of the attack, presence of aura, migraine intensity, accompanying symptoms, triggers, and medication use. | Device | Sequence 1 |
| Paper migraine diaryParticipants will manually document their migraine experiences on the paper migraine diary, including the date and time of the attack, presence of aura, migraine intensity, accompanying symptoms, triggers, and medication use. | Device | Sequence 2 |
| AI-empowered voice-interactive chatbotParticipants will interact with the chatbot on a daily basis to record their migraine experiences. They will be asked to initiate a conversation with the chatbot whenever they experience a migraine attack and provide the required information, including the date and time of the attack, presence of aura, migraine intensity, accompanying symptoms, triggers, and medication use. The chatbot will engage participants in a conversation to collect these data points and store them securely within the chatbot system. | Device | Sequence 2 |
Primary outcome
timeliness
Time frame: At the end of each 1-month intervention period
Timeliness will be defined as the proportion of migraine episodes recorded within 24 hours of onset. This measure will be derived from the data collected through the chatbot and paper diary.
Completeness
Time frame: At the end of each 1-month intervention period
Completeness will be defined as the proportion of diary entries with all required migraine-related information fully recorded. This measure will be derived from the data collected through the chatbot and paper diary.
Missed episodes
Time frame: At the end of each 1-month intervention period
Missed episodes will be defined as the proportion of migraine episodes not recorded; the number of missed episodes in each period will be obtained at the end-of-period questionnaire
Accuracy
Time frame: At the end of each 1-month intervention period
Accuracy will be defined as the proportion of diary entries in which all required migraine-related fields were recorded correctly. Accuracy will be adjudicated by assessing the consistency between migraine features recorded using the chatbot or paper diary and those reported during end-of-period online interviews with study staff. Discrepancies will be documented; records will be not altered for primary analyses. During these interviews, researchers will summarise the participant's recorded migraine information for that period, regardless of modality, and ask the participant to identify any errors.
5 secondary outcomes
Utilization
Time frame: At the end of each 1-month intervention period
Acceptability
Time frame: At the end of each 1-month intervention period
Usage
Time frame: At the end of each 1-month intervention period
Time per recording
Time frame: At the end of each 1-month intervention period
Validity
Time frame: At the end of each 1-month intervention period
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 15 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Migraine
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
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.
Yao Jie Xie, PhD principal investigator
The Hong Kong Polytechnic Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-empowered voice-interactive chatbot and Paper migraine diary in people with Migraine, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 7 inclusion and 3 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 15 Dec 2025. 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 Hong Kong. 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?
timeliness (time frame: At the end of each 1-month intervention period). The study lists 4 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 15 Dec 2025.