Clinical trial NCT02726217: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Type 2 Diabetes (T2D)
Keywords: CareSmarts
SMS-based mobile
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-04-01
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Measure of glucose
timeFrame: 3 Months
measure: Satisfaction with Care measured by Diabetes Treatment Satisfaction Questionnaire (DTSQ).
timeFrame: 3 Months
measure: Adherence to the diabetes self-management regimen using the Diabetes Self Management Questionnaire (DSMQ).
timeFrame: 3 Months
measure: Acceptability of the intervention protocol will be evaluated using a satisfaction survey.
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Mary Sevick, MD
role: PRINCIPAL_INVESTIGATOR
References: