NYULMC CareSmarts Pilot

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02726217
• Other study ID #: 15-00923
• Status: Completed
• Phase: N/A
• First received: March 29, 2016
• Last updated: May 4, 2017
• Start date: March 1, 2016
• Est. completion date: May 2, 2017

Study information

• Verified date: May 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 2, 2017
• Est. primary completion date: May 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes (T2D)

Intervention

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.
• Standard of Care Reminders and Self Assessments

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

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