NYULMC CareSmarts Pilot
- Conditions
- Type 2 Diabetes (T2D)Diabetes
- Interventions
- Behavioral: Standard of Care Reminders and Self AssessmentsBehavioral: CareSmarts Mobile Health Diabetes Program
- Registration Number
- NCT02726217
- Lead Sponsor
- NYU Langone Health
- Brief Summary
CareSmarts is a theory-driven behavioral intervention designed to improve self-care among patients with Type 2 diabetes (T2D) with poor glycemic control (HbA1c\>8%), through multiple mediators, including cuing, education, self-efficacy, social support, and health beliefs. Individuals will be randomly assigned with equal allocation to either the CareSmarts intervention or to usual care for 6 months.
- Detailed Description
CareSmarts is a mobile diabetes program that provides self-management support and team-based care management for people with diabetes through automated SMS messages. The program is a theory-driven behavioral intervention designed to improve self-care through multiple mediators, including cuing, education, self-efficacy, social support, and health beliefs. Participants in the program receive educational and motivational text messages about diabetes self-care, some prompts to engage in a particular action (for example, "Time to check your blood sugar"), and some self-assessment questions (such as, "Do you need refills of any of your medications?") to which the patient responds by texting. Participants' responses to self-assessment questions are used to facilitate remote monitoring and care management by the health care team. A response that is outside established parameters triggers an alert. Using protocols, nurses respond to each alert by the next business day.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- have a DRG Code of T2D, and be prescribed at least one oral T2D drug and/or insulin.
- must own an SMS capable mobile device and be willing to send and receive SMS messages regarding T2D self-management.
- The participant's physician of record will have verified that his/her patient can safely participant in an intervention study that targets an HbA1c <7%.
- unable or unwilling to provide informed consent
- unable to participate meaningfully in an intervention that involves use of SMS messages (e.g., due to uncorrected sight impairment, illiterate, non-English-speaking)
- unwilling to accept randomization assignment
- pregnant, plans to become pregnant in the next 6 months, or who become pregnant during the study
- gestational diabetes
- breastfeedling
- individuals who are institutionalized (e.g., in a nursing home or personal care facility, or those who are incarcerated and have limited control over self-management)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Standard of Care Reminders and Self Assessments Standard of Care reminders and assessments for individuals with Diabetes CareSmarts Intervention Standard of Care Reminders and Self Assessments Participants in the program receive text messages about diabetes self-care CareSmarts Intervention CareSmarts Mobile Health Diabetes Program Participants in the program receive text messages about diabetes self-care
- Primary Outcome Measures
Name Time Method Satisfaction with Care measured by Diabetes Treatment Satisfaction Questionnaire (DTSQ). 3 Months Adherence to the diabetes self-management regimen using the Diabetes Self Management Questionnaire (DSMQ). 3 Months Acceptability of the intervention protocol will be evaluated using a satisfaction survey. 3 Months Measure of glucose 3 Months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
New York University School of Medicine
🇺🇸New York, New York, United States