A Randomized Control Trial to Study the Effects of Automated Physician Directed Messaging on Patient Engagement in a Digital Diabetes Prevention Program
概览
- 阶段
- 不适用
- 干预措施
- Digital diabetes prevention program (dDPP)
- 疾病 / 适应症
- Pre Diabetes
- 发起方
- NYU Langone Health
- 入组人数
- 551
- 试验地点
- 1
- 主要终点
- Change in Hemoglobin A1c (HbA1c) Level (mmol/Mol)
- 状态
- 已完成
- 最后更新
- 2个月前
概览
简要总结
This study aims to understand the effects of automated physician directed messaging on patient engagement in the digital diabetes prevention program (dDPP). The messages are tailored to patient engagement levels based on established engagement thresholds, which are based on the patient's use of the dDPP application. The system is designed to minimize work for providers by sending automated targeted messages to patients to potentially increase engagement, prevent onset of diabetes and improve clinical outcomes. The patients in the study are automatically nudged using a combination of text messaging and MyChart messaging.
详细描述
Using a mixed-methods design, this study will be completed in three phases. For Phase 3, we aim to conduct a randomized control trial with 400 patients with pre-diabetic, all of whom will be using the dDPP application. Half of enrolled patients will be randomized to the intervention group and receive automated targeted messaging.
研究者
入排标准
入选标准
- •18 years or older, BMI ≥ 25 kg/m2 (\> 22 kg/m2 if self-identified as Asian)
- •Must be a NYU Langone patient
- •A diagnosis of prediabetes (either diagnosis of prediabetes or an HbA1C level of 5.7%-6.4% in past 12 months) or diabetes risk factors (BMI ≥ 25 kg/m2 or \> 22 kg/m2 if self-identified as Asian
- •Safe to engage in moderate physical exercise (as determined by their PCP)
- •Sufficient English to be able to complete the enrollment process
- •Has app-capable device with data to use the dDPP application and receive text messages
排除标准
- •Diagnosed with diabetes
- •Patients whose weight may vary considerably over the study's timeframe for reasons other than the intervention (e.g. cancer, pregnancy, ascites, severe CHF)
- •Patients with severe psychiatric disease or dementia
- •Active health condition that prevents them from engaging in moderate exercise
研究组 & 干预措施
Experimental group
Participants will be enrolled virtually into a digital diabetes prevention program through the Noom app and willing to receive text messages based on their engagement levels in Noom from the study team, as well as complete text-based surveys.
干预措施: Digital diabetes prevention program (dDPP)
Experimental group
Participants will be enrolled virtually into a digital diabetes prevention program through the Noom app and willing to receive text messages based on their engagement levels in Noom from the study team, as well as complete text-based surveys.
干预措施: Adapted dDPP-EHR tool
Control group
Participants will be enrolled virtually into the digital diabetes prevention program through the Noom app and willing to receive general text messages from the study team
干预措施: Digital diabetes prevention program (dDPP)
结局指标
主要结局
Change in Hemoglobin A1c (HbA1c) Level (mmol/Mol)
时间窗: Baseline, Month 6
Repeated measurements of participant HbA1c will be taken via HbA1C home test kit and electronic health records. Data will be collected at discrete time points: 0 month (at enrollment), 6 months, 12 months (study completion). Changes were assessed relative to baseline.
Change in Hemoglobin A1c (HbA1c) Level (mmol/Mol)
时间窗: Baseline, Month 12
Repeated measurements of participant HbA1c will be taken via HbA1C home test kit and electronic health records. Data will be collected at discrete time points: 0 month (at enrollment), 6 months, 12 months (study completion). Changes were assessed relative to baseline.
Change in Body Weight (Lbs)
时间窗: Baseline, Month 6
Repeated measurements of participant weight will be taken via remote Bluetooth-connected weight scales, measured in light clothing without shoes. Changes were assessed relative to baseline.
Change in Body Weight (Lbs)
时间窗: Baseline, Month 12
Repeated measurements of participant weight will be taken via remote Bluetooth-connected weight scales, measured in light clothing without shoes. Data will be collected at discrete time points: 0 month (at enrollment), 3 months, 6 months, 9 months, 12 months (study completion). Changes were assessed relative to baseline.
Change in Body Mass Index (BMI) (Lbs/in^2)
时间窗: Baseline, Month 6
BMI was calculated using height (in) from electronic health records and weight (lbs) from remote Bluetooth-connected weight scales. Data was collected at discrete time points: 0 month (at enrollment), 3 months, 6 months, 9 months, 12 months (study completion). Changes were assessed relative to baseline.
Change in Body Mass Index (BMI) (Lbs/in^2)
时间窗: Baseline, Month 12
BMI was calculated using height (in) from electronic health records and weight (lbs) from remote Bluetooth-connected weight scales. Data was collected at discrete time points: 0 month (at enrollment), 3 months, 6 months, 9 months, 12 months (study completion). Changes were assessed relative to baseline.
次要结局
- Engagement With the dDPP Platform(Month 6)
- Engagement With the dDPP Platform(Month 12)