Using Gout Buddy to Enhance Gout Management

NCT07004231 | Active Not Recruiting

• 1 other identifier: 2024-4476
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Dietary management is crucial for gout, but patients often lack adequate dietary literacy. However, patients often lack adequate dietary literacy and struggle to navigate complex dietary recommendations. Gout Buddy is an autonomous AI agent to offer personalized gout education and awareness tailored to individual needs. This study aims to evaluate the effectiveness and user experience of Gout Buddy, in improving dietary literacy and gout management. Materials and methods: A two-arm RCT will randomize patients with gout to either the intervention (Gout Buddy) or control (standard care). Two study visits within 3-6 months will assess changes in dietary literacy and gout management behaviours. Qualitative interviews will be conducted with intervention arm participants and multidisciplinary care team members to explore their experiences with Gout Buddy till the point of data saturation. Expected Outcomes: The current trial is expected to demonstrate the effectiveness of Gout Buddy in improving dietary literacy and gout management compared to standard care. Qualitative data will provide rich insights into user engagement, perceived benefits, challenges, and the feasibility of integrating the chatbot into routine gout management. Significance: This study will provide evidence on the potential of AI chatbots to enhance gout self-management. The findings will inform the development and implementation of digital health tools for chronic disease management, potentially improving patient outcomes and reducing the burden of gout.

Conditions

Gout

Keywords

gout; dietary literacy; Artificial Intelligence; Chatbot; Primary care

Outcome Measures

Primary Outcomes (4)

• Food Frequency Questionnaire

  Food Frequency Questionnaire-SF (FFQ-SF) is a limited checklist of foods and beverages with a frequency response section for subjects to report how often each item was consumed over a specified period of time. Changes in the frequency of consuming each food item will be compared to baseline consumption.

  through study completion, an average of 3 to 6 months

• Dietary literacy about gout

  Change in the scores using Dietary literacy about gout questionnaire; a newly developed questionnaire to assess patients' understanding of gout diet comprising 19 questions scored from a scale of 1-5: 1 (Strongly agree), 2 (agree), 3 (uncertain), 4 (disagree) and 5 (strongly disagree). A higher score indicates better understanding.

  through study completion, an average of 3 to 6 months

• Medication adherence report scale- 5 items

  Change in the scores using five item Medication Adherence Report Scale (MARS-5); MARS-5 score was calculated by summing the numeric score (range 1-5) from each question for out of 25 (range 5-25). A higher score indicates better adherence.

  through study completion, an average of 3 to 6 months

• Health related quality of life (HRQoL)

  Change in the scores using EQ-5D-5L questionnaire; The EQ-5D-5L tool comprises five dimensions, each describing a different aspect of health: mobility, self-care, usual activities, pain/ discomfort and anxiety/ depression. Each dimension has five response levels (no problems, slight problems, moderate problems, severe problems, unable to/ extreme problems). The proportion of patients reporting each level of problem on each dimension of the EQ-5D will be determined through study completion and compared. EQ VAS (Visual Analogue Scale) provides a quantitative measure of the patient's perception of their overall health. The EQ VAS records the respondent's overall current health on a vertical scale (0-100), where the endpoints are labelled '0-The worst health you can imagine' and '100-The best health you can imagine'.

  through study completion, an average of 3 to 6 months

Secondary Outcomes (1)

• exploring the views, acceptance, and potential challenges associated with using the Gout Buddy

  3-6 months

Study Arms (2)

Intervention arm using Gout Buddy

EXPERIMENTAL

Participants in the intervention group will receive usual care, including standard medical management and dietary counselling for gout. In addition, they will use the Gout Buddy chatbot (a prototype mobile application developed by HELF AI). The chatbot will be installed on their mobile phones (iOS or Android, 2020 models or newer) and requires a stable but standard mobile internet connectivity. Participants will download and enroll in Gout Buddy with the guidance of study team. The chatbot provides interactive support by allowing users to ask questions and receive daily tips and recommendations to help them manage their condition effectively. Notifications will be sent by Gout Buddy to the users' phones; these happen one to three times every day and mainly consist of daily tips related to better gout literacy and self-efficacy. The notifications are also useful conversation starters with users.

Other: GOUT Buddy, an AI chatbot

Standard care

NO INTERVENTION

Participants in the control group will receive usual care, which includes standard medical management and dietary counselling for gout. They will also receive a pamphlet containing information on dietary management for gout.

Interventions

GOUT Buddy, an AI chatbot OTHER

AI Chatbot ("GOUT Buddy") offers personalized gout education and awareness tailored to individual needs

Intervention arm using Gout Buddy

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 21 years
• At least one serum uric acid \> 360 μmol/L or an episode of acute gout attack within the last 18 months
• Able to read and speak English
• Access to an internet-enabled device compatible with Gout Buddy

You may not qualify if:

• Not a Singapore citizen or permanent resident
• Pregnant
• End-stage kidney disease or on renal replacement therapy
• Known terminal illness
• Visual and/or hearing impairment
• Cognitive impairment or mental illness
• Unable to provide informed consent
• Individuals who do not have a personal mobile device with internet access

Sponsors & Collaborators

• SingHealth Polyclinics: lead

Study Sites (1)

SingHealth Polyclinics

Singapore, Singapore, Singapore

Location

Related Publications (12)

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  PMID: 22995041 BACKGROUND

• Fields TR, Batterman A. How Can We Improve Disease Education in People with Gout? Curr Rheumatol Rep. 2018 Mar 8;20(3):12. doi: 10.1007/s11926-018-0720-x.

  PMID: 29516200 BACKGROUND

• Bhattad PB, Pacifico L. Empowering Patients: Promoting Patient Education and Health Literacy. Cureus. 2022 Jul 27;14(7):e27336. doi: 10.7759/cureus.27336. eCollection 2022 Jul.

  PMID: 36043002 BACKGROUND

• Hoving C, Visser A, Mullen PD, van den Borne B. A history of patient education by health professionals in Europe and North America: from authority to shared decision making education. Patient Educ Couns. 2010 Mar;78(3):275-81. doi: 10.1016/j.pec.2010.01.015. Epub 2010 Mar 1.

  PMID: 20189746 BACKGROUND

• Kuwabara A, Su S, Krauss J. Utilizing Digital Health Technologies for Patient Education in Lifestyle Medicine. Am J Lifestyle Med. 2019 Dec 13;14(2):137-142. doi: 10.1177/1559827619892547. eCollection 2020 Mar-Apr.

  PMID: 32231478 BACKGROUND

• Aggarwal A, Tam CC, Wu D, Li X, Qiao S. Artificial Intelligence-Based Chatbots for Promoting Health Behavioral Changes: Systematic Review. J Med Internet Res. 2023 Feb 24;25:e40789. doi: 10.2196/40789.

  PMID: 36826990 BACKGROUND

• Rothenberg E, Strandhagen E, Samuelsson J, Ahlner F, Rydberg Sterner T, Skoog I, Lundberg CE. Relative Validity of a Short 15-Item Food Frequency Questionnaire Measuring Dietary Quality, by the Diet History Method. Nutrients. 2021 Oct 24;13(11):3754. doi: 10.3390/nu13113754.

  PMID: 34836011 BACKGROUND

• Wijnands JM, Viechtbauer W, Thevissen K, Arts IC, Dagnelie PC, Stehouwer CD, van der Linden S, Boonen A. Determinants of the prevalence of gout in the general population: a systematic review and meta-regression. Eur J Epidemiol. 2015 Jan;30(1):19-33. doi: 10.1007/s10654-014-9927-y. Epub 2014 Jul 27.

  PMID: 25064615 RESULT

• Huang J, Ma ZF, Zhang Y, Wan Z, Li Y, Zhou H, Chu A, Lee YY. Geographical distribution of hyperuricemia in mainland China: a comprehensive systematic review and meta-analysis. Glob Health Res Policy. 2020 Nov 30;5(1):52. doi: 10.1186/s41256-020-00178-9.

  PMID: 33292806 RESULT

• Teng GG, Ang LW, Saag KG, Yu MC, Yuan JM, Koh WP. Mortality due to coronary heart disease and kidney disease among middle-aged and elderly men and women with gout in the Singapore Chinese Health Study. Ann Rheum Dis. 2012 Jun;71(6):924-8. doi: 10.1136/ard.2011.200523. Epub 2011 Dec 15.

  PMID: 22172492 RESULT

• Oka P, Chong WM, Ng DX, Aau WK, Tan NC. Epidemiology and risk factors associated with gout control among adult Asians: a real-world retrospective cohort study. Front Med (Lausanne). 2023 Sep 7;10:1253839. doi: 10.3389/fmed.2023.1253839. eCollection 2023.

  PMID: 37746085 RESULT

• Serlachius A, Schache K, Kieser A, Arroll B, Petrie K, Dalbeth N. Association Between User Engagement of a Mobile Health App for Gout and Improvements in Self-Care Behaviors: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Aug 13;7(8):e15021. doi: 10.2196/15021.

  PMID: 31411147 RESULT

MeSH Terms

Conditions

Gout

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ngiap Chuan Tan, MMed

  SingHealth Polyclinics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 4, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

SG (1)