NYULMC CareSmarts Pilot

NYU Langone Health

Status: Completed

Conditions: Type 2 Diabetes (T2D); Diabetes

Treatments: Behavioral: Standard of Care Reminders and Self Assessments; Behavioral: CareSmarts Mobile Health Diabetes Program

Study type: Interventional

Funder types: Other

Identifiers

NCT02726217

15-00923

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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%.

Exclusion criteria

• 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

CareSmarts Intervention

Experimental group

Description:

Participants in the program receive text messages about diabetes self-care

Treatment:

Behavioral: CareSmarts Mobile Health Diabetes Program

Behavioral: Standard of Care Reminders and Self Assessments

Control

Active Comparator group

Description:

Standard of Care reminders and assessments for individuals with Diabetes

Treatment:

Behavioral: Standard of Care Reminders and Self Assessments