Using Gout Buddy to Enhance Dietary Literacy and Gout Management-A Mixed Method Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Food Frequency Questionnaire
研究概览
简要总结
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.
详细描述
Background and Rationale:
Gout is a chronic and progressive form of inflammatory arthritis characterized by the accumulation of urate crystals in the joints, leading to recurrent episodes of severe pain, redness, and swelling. It is primarily caused by hyperuricemia, a condition in which there is an excess of uric acid in the blood. Gout is more common in men and older adults and is often associated with comorbidities such as hypertension, diabetes, and cardiovascular disease.
A 2015 meta-analysis of global gout studies estimated a pooled prevalence of 0.6%, though with significant variation. [1] In mainland China, the prevalence of gout from 1998 to 2019 was 1.6%, and a local study from Singapore among Chinese individuals found that 4.1% had a history of physician-diagnosed gout. [2,3] Despite the availability of effective treatments, about one-third patients struggle with managing their condition.[4] Poor control can be attributed due to lack of understanding of gout's etiology, progression, and the importance of adherence to prescribed therapies. [5] Poor management of gout can result in frequent flare-ups, joint damage, and decreased quality of life.
Research indicates that patient education significantly impacts the successful management of gout. [6] However, traditional methods of patient education-such as pamphlets, infrequent consultations, and group sessions-often fall short in engaging patients and providing timely information tailored to their individual needs. [7,8] Additionally, these methods do not accommodate the continuous need for information that patients may have outside of clinic hours. Therefore, there is a need for innovative, accessible, and patient-centered educational tools that can bridge these gaps and empower patients to manage their gout more effectively.
Digital health interventions have emerged as a promising solution to these challenges. By leveraging technology, these interventions can provide continuous support, personalized information, and interactive educational content to patients. [9] Chatbots, in particular, have gained attention for their efficacy of health behaviour change among large and diverse population. [10] Chatbots can be particularly beneficial in chronic disease management, where ongoing patient education and engagement are critical. By providing instant access to reliable information and guidance, chatbots can help patients better understand their condition, adhere to treatment plans, and make informed decisions about their health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Not a Singapore citizen or permanent resident
- •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
研究组 & 干预措施
Standard care
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.
Intervention arm using Gout Buddy
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.
干预措施: GOUT Buddy, an AI chatbot (Other)
结局指标
主要结局
Food Frequency Questionnaire
时间窗: through study completion, an average of 3 to 6 months
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.
Dietary literacy about gout
时间窗: through study completion, an average of 3 to 6 months
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.
Medication adherence report scale- 5 items
时间窗: through study completion, an average of 3 to 6 months
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.
Health related quality of life (HRQoL)
时间窗: through study completion, an average of 3 to 6 months
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'.
次要结局
- exploring the views, acceptance, and potential challenges associated with using the Gout Buddy(3-6 months)
研究者
Tan Ngiap Chuan
Principal Investigator
SingHealth Polyclinics
