Clinical trial NCT04773834: Evaluation of an Automated Physician-Directed Messaging on Patient Engagement in the Digital Diabetes Prevention Program
Official title: A Randomized Control Trial to Study the Effects of Automated Physician Directed Messaging on Patient Engagement in a Digital Diabetes Prevention Program
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pre Diabetes
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-02-26
Enrollment: 435
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hemoglobin A1c (HbA1c) level (mmol/mol)
timeFrame: through completion of dDPP program (average 1 year)
measure: Body Weight (kilograms)
timeFrame: through completion of dDPP program (average 1 year)
measure: Body Mass Index (BMI) (kg/m2)
timeFrame: through completion of dDPP program (average 1 year)
Secondary outcomes:
measure: dDPP platform user log-ins
timeFrame: through completion of dDPP program (average 1 year)
measure: dDPP platform lesson plans completed
timeFrame: through completion of dDPP program (average 1 year)
measure: dDPP platform coach messages sent
timeFrame: through completion of dDPP program (average 1 year)
measure: dDPP platform group social posts sent
timeFrame: through completion of dDPP program (average 1 year)
measure: dDPP platform step log (steps/day)
timeFrame: through completion of dDPP program (average 1 year)
measure: dDPP platform exercise log (min)
timeFrame: through completion of dDPP program (average 1 year)
measure: dDPP platform meal log (food item and calories/day)
timeFrame: through completion of dDPP program (average 1 year)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Devin Mann, MD
role: PRINCIPAL_INVESTIGATOR
References: