Feasibility of Use of Fitbit, Brief DSMES, and Targeted Text Messaging in Sedentary Adults With Type 2 Diabetes in Primary Care Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 3
- 主要终点
- Feasibility - Recruitment
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Experimental: Fitbit and AI Chatbot
Participants will wear their Fitbit devices daily and receive personalized messages from the AI Chatbot weekly with setting a new exercise goal based on their previous week's activity level. Additionally, they can engage with the AI Chatbot through text message for further support, education, and goal setting. Participants will interact throughout the week on completing their goal or where they might improve.
干预措施: Fitbit and AI Chatbot (Behavioral)
Active Comparator: Controls
The control group will be established through a rigorous retrospective chart review of patients with type 2 diabetes who meet the study's inclusion criteria but have not participated in the intervention.
干预措施: Routine Care (Other)
结局指标
主要结局
Feasibility - Recruitment
时间窗: 6 months
Recruitment of 36 adults within 6 months.
Feasibility - Retainment
时间窗: 6 months
Retainment of 85% of participants for post-assessments.
Feasibility - Fitbit wear
时间窗: 12 Weeks
Fitbit wear ≥ 5 days/week \> 12 hours per day, wear at night \> 3 nights/week.
Feasibility - Text message responses
时间窗: 12 Weeks
Responding to 80% of text messages when prompted.
Feasibility - Technical issues
时间窗: 12 Weeks
Participation with ≤10% technical issues (battery life, data sync between device and app/dashboard, device failure).
Acceptability - Participant Experience and Satisfaction
时间窗: 12 Weeks
Obtaining \> 60% satisfaction from participants via a satisfaction survey.
次要结局
- Cost(Weekly, 12 weeks)
- Experience with technology(12 Weeks)
- Change in HbA1c(12 Weeks)
- Change in Body Mass Index(12 Weeks)
- Change in lipid panel(12 Weeks)
- Change in weight(12 Weeks)
- Change in blood pressure(12 Weeks)
- Change in diabetes distress(12 Weeks)
- Revenue(Weekly, 12 weeks)