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NYULMC CareSmarts Pilot

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02726217
Enrollment
26
Registered
2016-04-01
Start date
2016-03-01
Completion date
2017-05-02
Last updated
2017-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Type 2 Diabetes (T2D)

Keywords

CareSmarts, SMS-based mobile

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.

Interventions

BEHAVIORALCareSmarts 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.

BEHAVIORALStandard of Care Reminders and Self Assessments

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Measure of glucose3 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026