Evaluation of an Automated Physician-Directed Messaging on Patient Engagement in the Digital Diabetes Prevention Program

Pre Diabetes Clinical Trial

Official title:

A Randomized Control Trial to Study the Effects of Automated Physician Directed Messaging on Patient Engagement in a Digital Diabetes Prevention Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04773834
• Other study ID #: 20-01548
• Secondary ID: 1R18DK118545-01A
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: September 1, 2024

Study information

• Verified date: March 2024
• Source: NYU Langone Health
• Contact: Sumaiya Tasneem
• Phone: 646-501-2904
• Email: sumaiya.tasneem[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 490
• Est. completion date: September 1, 2024
• Est. primary completion date: June 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Pre Diabetes
• Prediabetic State

Intervention

Other:
• Digital diabetes prevention program (dDPP)
The digital diabetes prevention program is through the Noom app, and the three devices (Fitbit physical activity tracker, Fitbit weight scale, and self-check hemoglobin a1c kit). This is a one year diabetes prevention program where participants will be expected to participate in 5 to 7 interviews over a 18 month period.
• Adapted dDPP-EHR tool
This is a product of Phase 1 and 2 of this study where participants will receive detailed text messaging regarding their engagement levels in Noom app.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c (HbA1c) level (mmol/mol)	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)	through completion of dDPP program (average 1 year)
Primary	Body Weight (kilograms)	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)	through completion of dDPP program (average 1 year)
Primary	Body Mass Index (BMI) (kg/m2)	BMI will be calculated using height (m) from electronic health records and weight (kg) from remote Bluetooth-connected weight scales. Data will be collected at discrete time points: 0 month (at enrollment), 3 months, 6 months, 9 months, 12 months (study completion)	through completion of dDPP program (average 1 year)
Secondary	dDPP platform user log-ins	Perceptions of patient engagement will be collected via surveys from patients measured using data on number of dDPP logins, as provided from the Noom platform	through completion of dDPP program (average 1 year)
Secondary	dDPP platform lesson plans completed	Perceptions of patient engagement will be collected via surveys from patients using the number of completion of weekly lesson plans, as provided from the Noom platform	through completion of dDPP program (average 1 year)
Secondary	dDPP platform coach messages sent	Perceptions of patient engagement will be collected via surveys from patients using data on number of messages to coaches as provided from the Noom platform	through completion of dDPP program (average 1 year)
Secondary	dDPP platform group social posts sent	Perceptions of patient engagement will be collected via surveys from patients using data on number of messages to online social groups, as provided from the Noom platform	through completion of dDPP program (average 1 year)
Secondary	dDPP platform step log (steps/day)	Perceptions of patient engagement will be collected via surveys from patients using data on number of completed platform step logs, as provided from the Noom platform	through completion of dDPP program (average 1 year)
Secondary	dDPP platform exercise log (min)	Perceptions of patient engagement will be collected via surveys from patients using data on number of completed platform exercise logs, as provided from the Noom platform	through completion of dDPP program (average 1 year)
Secondary	dDPP platform meal log (food item and calories/day)	Perceptions of patient engagement will be collected via surveys from patients using data on number of completed meal logs, as provided from the Noom platform	through completion of dDPP program (average 1 year)