Back to resultsNYULMC CareSmarts Pilot
Primary Purpose
Diabetes, Type 2 Diabetes (T2D)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CareSmarts Mobile Health Diabetes Program
Standard of Care Reminders and Self Assessments
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes focused on measuring CareSmarts, SMS-based mobile
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)
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CareSmarts Intervention
Control
Arm Description
Participants in the program receive text messages about diabetes self-care
Standard of Care reminders and assessments for individuals with Diabetes
Outcomes
Primary Outcome Measures
Measure of glucose
Satisfaction with Care measured by Diabetes Treatment Satisfaction Questionnaire (DTSQ).
Adherence to the diabetes self-management regimen using the Diabetes Self Management Questionnaire (DSMQ).
Acceptability of the intervention protocol will be evaluated using a satisfaction survey.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02726217
Brief Title
NYULMC CareSmarts Pilot
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
May 2, 2017 (Actual)
Study Completion Date
May 2, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Type 2 Diabetes (T2D)
Keywords
CareSmarts, SMS-based mobile
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CareSmarts Intervention
Arm Type
Experimental
Arm Description
Participants in the program receive text messages about diabetes self-care
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Standard of Care reminders and assessments for individuals with Diabetes
Intervention Type
Behavioral
Intervention Name(s)
CareSmarts Mobile Health Diabetes Program
Intervention Description
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
Intervention Name(s)
Standard of Care Reminders and Self Assessments
Primary Outcome Measure Information:
Title
Measure of glucose
Time Frame
3 Months
Title
Satisfaction with Care measured by Diabetes Treatment Satisfaction Questionnaire (DTSQ).
Time Frame
3 Months
Title
Adherence to the diabetes self-management regimen using the Diabetes Self Management Questionnaire (DSMQ).
Time Frame
3 Months
Title
Acceptability of the intervention protocol will be evaluated using a satisfaction survey.
Time Frame
3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Sevick, MD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
NYULMC CareSmarts Pilot
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