NYULMC CareSmarts Pilot

May 4, 2017 updated by: NYU Langone Health

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure of glucose
Time Frame: 3 Months
3 Months
Satisfaction with Care measured by Diabetes Treatment Satisfaction Questionnaire (DTSQ).
Time Frame: 3 Months
3 Months
Adherence to the diabetes self-management regimen using the Diabetes Self Management Questionnaire (DSMQ).
Time Frame: 3 Months
3 Months
Acceptability of the intervention protocol will be evaluated using a satisfaction survey.
Time Frame: 3 Months
3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Mary Sevick, MD, New York University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

May 2, 2017

Study Completion (Actual)

May 2, 2017

Study Registration Dates

First Submitted

March 29, 2016

First Submitted That Met QC Criteria

March 29, 2016

First Posted (Estimate)

April 1, 2016

Study Record Updates

Last Update Posted (Actual)

May 5, 2017

Last Update Submitted That Met QC Criteria

May 4, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-00923

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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