NYULMC CareSmarts Pilot

Study Overview
=================
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.

Official Title
-----------------
NYULMC-CareSmarts Study: A Pilot Study to Determine the Feasibility, Acceptability, and Potential Efficacy of an SMS-based Mobile Intervention to Enhance Type 2 Diabetes Self-management

Conditions
-----------------
Diabetes, Type 2 Diabetes (T2D)

Intervention / Treatment
-----------------
* Behavioral: CareSmarts Mobile Health Diabetes Program
* Behavioral: Standard of Care Reminders and Self Assessments


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CareSmarts Intervention<br>Participants in the program receive text messages about diabetes self-care | Behavioral: CareSmarts Mobile Health Diabetes Program<br>* 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.<br>Behavioral: Standard of Care Reminders and Self Assessments<br> <br> |
| Active Comparator: Control<br>Standard of Care reminders and assessments for individuals with Diabetes | Behavioral: Standard of Care Reminders and Self Assessments<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of glucose |  | 3 Months | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CareSmarts, SMS-based mobile