NYULMC CareSmarts Pilot

NCT ID: NCT02726217

Last Updated: 2017-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-01
• Study Completion Date: 2017-05-02

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.

Conditions

Diabetes; Type 2 Diabetes (T2D)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

CareSmarts Intervention

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

Group Type: EXPERIMENTAL

CareSmarts Mobile Health Diabetes Program

Intervention Type: BEHAVIORAL

Nurses from Diabetes Clinic will use a web-based enrollment form that includes the patient's mobile phone number, diabetes care plan, and preferred times for receiving messages. Participants in the program receive text messages about diabetes self-care. The contents of the messages that the participants receive are modified through software every two weeks as needed, based on their interactions with the system. Participants follow a flexible education curriculum in which they move from one topic to the next at their own pace.

Standard of Care Reminders and Self Assessments

Intervention Type: BEHAVIORAL

Control

Standard of Care reminders and assessments for individuals with Diabetes

Group Type: ACTIVE_COMPARATOR

Standard of Care Reminders and Self Assessments

Intervention Type: BEHAVIORAL

Interventions

CareSmarts Mobile Health Diabetes Program

Nurses from Diabetes Clinic will use a web-based enrollment form that includes the patient's mobile phone number, diabetes care plan, and preferred times for receiving messages. Participants in the program receive text messages about diabetes self-care. The contents of the messages that the participants receive are modified through software every two weeks as needed, based on their interactions with the system. Participants follow a flexible education curriculum in which they move from one topic to the next at their own pace.

Intervention Type: BEHAVIORAL

Standard of Care Reminders and Self Assessments

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary Sevick, MD

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

15-00923

Identifier Type: -

Identifier Source: org_study_id