- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07934888
Combining an Effective Rule-based Chatbot With ChatGPT-supported Real-time Question-answer Functions to Promote Seasonal Influenza Vaccination Among Community-dwelling People Aged 65 Years and Above
Combining an Effective Rule-based Chatbot With ChatGPT-supported Real-time Question-answer Functions to Promote Seasonal Influenza Vaccination Among Community-dwelling People Aged 65 Years and Above: a Partially Blinded Randomized Controlled Trial
This study is a partially blinded (outcome assessors and data analysts) and parallel-group randomized controlled trial. Community-dwelling people aged ≥65 years who have not received the SIV for the approaching flu season will be randomized evenly (1:1) into either the intervention group or the control group. During the intervention period, the intervention group will have access to the hybrid combination of a rule-based chatbot (SIV-Chatbot) with the ChatGPT-supported real-time Question & Answer (QA) functions, while the control group will have access only to the SIV-Chatbot.
The SIV-Chatbot will deliver the same interventions for both groups. The number of intervention sessions (four) and timing (week 0, 2, 4 & 6) will also be the same. In the intervention group, the hybrid Chatbot will invite the participants to raise open-ended questions related to SIV using flexible methods (such as voice messages, typing with keyboards, or handwriting) at each session. The ChatGPT will answer these questions immediately in the format of text messages. The functions can be used repeatedly throughout the intervention period (weeks 0-6), and participants will be free to spend as much time as they want on such functions.
Telephone interviews will be conducted at baseline (T0), after completion of the intervention (T1), and six months after T1 (T2). The primary outcome will be the self-reported SIV uptake measured at T2. The research team will validate that outcome by requesting the participants upload an image of their SIV receipt, while hiding their personal identification, via the WhatsApp account used in this study.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Zixin Wang, PhD
- Telefonnummer: +852 22528474
- E-Mail: wangzx@cuhk.edu.hk
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- aged ≥65 years
- possession of a Hong Kong ID
- able to speak and comprehend Cantonese
- have a smartphone with internet access
- have either installed or are willing to install WhatsApp on their smartphone
- have not taken seasonal influenza vaccination for the approaching flu season
Exclusion Criteria:
- score ≤16 in the validated telephone version of the Cantonese Mini-Mental State Examination (T-CMMSE)
- either blindness or deafness
- with known contraindications to the SIV as indicated by the Hong Kong Centre for Health Protection (e.g., history of severe allergic reactions to any of the vaccine component or a previous dose of SIV and bleeding disorders)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Intervention group
Have access to the hybrid combination of a rule-based chatbot (SIV-Chatbot) with the ChatGPT-supported real-time QA functions |
After assessing participants' stage of change (SOC) regarding SIV uptake, the rule-based component (SIV-Chatbot) will deliver online interventions tailored to their current SOC. There will be four intervention sessions at week 0, 2, 4 and 6. In addition, the hybrid Chatbot will invite the participants to raise open-ended questions related to SIV using flexible methods at each session. The ChatGPT will answer these questions immediately in the format of text messages. The functions can be used repeatedly throughout the intervention period (weeks 0-6), and participants will be free to spend as much time as they want on such functions. |
|
Aktiver Komparator: Control group
Have access only to a rule-based chatbot (SIV-Chatbot) |
After assessing participants' stage of change (SOC) regarding SIV uptake, the rule-based chatbot (SIV-Chatbot) will deliver online interventions tailored to their current SOC. There will be four intervention sessions at week 0, 2, 4 and 6. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Uptake of seasonal influenza vaccination
Zeitfenster: Six months after completion of the intervention
|
The primary outcome will be the self-reported seasonal influenza vaccination uptake measured at T2 (six months after completion of the intervention). The research team will validate that outcome by requesting the participants upload an image of their receipt. |
Six months after completion of the intervention
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Stage of change related to seasonal influenza vaccination uptake
Zeitfenster: T0 (baseline), T1 (after completion of intervention), and T2 (six months after completion of the intervention)
|
Participants' SOC will be measured at T0 (baseline), T1 (after completion of intervention), and T2 (six months after completion of the intervention) by using validated questions |
T0 (baseline), T1 (after completion of intervention), and T2 (six months after completion of the intervention)
|
|
Knowledge and attitudes related to seasonal influenza vaccination
Zeitfenster: T0 (baseline) and T2 (6 months after completion of the intervention)
|
Knowledge and attitudes will be measured at T0 (baseline) and T2 (6 months after completion of the intervention) by validated tools |
T0 (baseline) and T2 (6 months after completion of the intervention)
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- GRF14611325
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
The data presented in this study are available from the corresponding author upon request. The data are not publicly available as they contain sensitive personal information.
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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