AI Chatbot for Migraine Management in Hong Kong Women

The Hong Kong Polytechnic University

Status: Begins enrollment in 3 months

Conditions: Migraine

Treatments: Device: AI-empowered voice-interactive chatbot; Device: Paper migraine diary

Study type: Interventional

Funder types: Other

Identifiers

NCT06920602

RG2024/2025_A_11 (Other Grant/Funding Number)

HSEARS20241015007

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Sequence 1

Experimental group

Description:

AI-empowered voice-interactive chatbot followed by paper migraine diary

Treatment:

Device: AI-empowered voice-interactive chatbot

Device: Paper migraine diary

Device: Paper migraine diary

Device: AI-empowered voice-interactive chatbot

Sequence 2

Experimental group

Description:

Paper migraine diary followed by AI-empowered voice-interactive chatbot

Treatment:

Device: AI-empowered voice-interactive chatbot

Device: Paper migraine diary

Device: Paper migraine diary

Device: AI-empowered voice-interactive chatbot