Fitbit and AI Chatbot in Sedentary Primary Care Patients With T2D

Официальное название

Feasibility of Use of Fitbit, Brief DSMES, and Targeted Text Messaging in Sedentary Adults With Type 2 Diabetes in Primary Care Settings

Обзор

The goal of this observational study is to evaluate the feasibility and acceptability of a 12-week intervention utilizing a Fitbit and artificial intelligence (AI)-delivered diabetes self-management education and support (DSMES) with tailored text messages. The main question it aims to answer is: Does providing a wearable fitness and activity tracker plus AI-tailored and DSMES improve clinical outcomes for patients with type 2 diabetes? Participants will complete a baseline visit, wear a Fitbit and answer text messages for 12-weeks, and complete by a final visit.

Вмешательства

• Поведенческое Fitbit and AI Chatbot
  Participants will wear their Fitbit devices daily for 12-weeks and will receive personalized messages from the AI Chatbot every week with a new exercise recommendation based on their previous week's activity level. Additionally, they can engage with the AI Chatbot through text message for further support and education.
• Другое Routine Care
  The control group will consist of patients with type 2 diabetes who meet the study's inclusion criteria but have not participated in the intervention.

Первичные конечные точки

• Feasibility - Recruitment [Срок оценки: 6 months]
• Feasibility - Retainment [Срок оценки: 6 months]
• Feasibility - Fitbit wear [Срок оценки: 12 Weeks]
• Feasibility - Text message responses [Срок оценки: 12 Weeks]
• Feasibility - Technical issues [Срок оценки: 12 Weeks]
• Acceptability - Participant Experience and Satisfaction [Срок оценки: 12 Weeks]

Вторичные конечные точки (10)

• Change in HbA1c [Срок оценки: 12 Weeks]
• Change in Body Mass Index [Срок оценки: 12 Weeks]
• Change in lipid panel [Срок оценки: 12 Weeks]
• Change in weight [Срок оценки: 12 Weeks]
• Change in blood pressure [Срок оценки: 12 Weeks]
• Change in diabetes distress [Срок оценки: 12 Weeks]
• Experience with technology [Срок оценки: 12 Weeks]
• Experience with technology [Срок оценки: 12 Weeks]
• Cost [Срок оценки: Weekly, 12 weeks]
• Revenue [Срок оценки: Weekly, 12 weeks]

Критерии участия

Критерии включения

• Diagnosed with type 2 diabetes per investigator discretion
• No more than 20% of the sample will have A1c < 7.5% (confirmed by medical record review or an A1c completed within 3 months of the screening visit)
• Age ≥18 years and ≤ 80 years
• Does not meet ADA guidelines for physical activity (< 150 minutes of aerobic exercise per week defined as any activity where the participant can talk but not sing)
• Has a smartphone compatible with a Fitbit

Критерии исключения

• Completing more than 60 minutes of moderate to vigorous activity per week defined as activity where you cannot sing (moderate) or can't say more than a few words without gasping for breath (vigorous)(14)
• Any medical condition which, in the opinion of the investigator, would put the participant at an unacceptable safety risk, such as untreated malignancy, unstable cardiac disease, unstable or end-stage renal disease, and/or eating disorders.
• Current or known history of coronary artery disease that is not stable with medical management, including unstable angina, or angina that prevents moderate exercise despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the previous 12- months
• Any planned surgery during the study which could be considered major in the opinion of the investigator
• Blood disorder or dyscrasia within 3 months before screening, or the use of hydroxyurea, which, in the investigator's opinion, could interfere with the determination of HbA1c
• Has taken oral or injectable steroids within the past 8 weeks or plans to take oral or injectable steroids during the study, as they may interfere with the determination of HbA1c.
• Planning to move from Colorado within 3 months
• Current Pregnancy or planning on pregnancy in the next 3 months
• Unable to safely comply with study procedures and reporting requirements (e.g. impairment of vision that impacts ability to see FitBit, impaired memory)
• Unable to speak English as this is a small feasibility study that does not have the resources to adapt the intervention for Spanish
• Current participation in another diabetes-related clinical trial

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• University of Colorado, Anschutz — Aurora

Идентификаторы

NCT: NCT07005362 · 24-2577

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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