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Completed

NCT Number: NCT02726217

NYULMC CareSmarts Pilot

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CareSmarts Mobile Health Diabetes Program

Behavioral

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

Behavioral

Primary outcomes

  1. Measure of glucose

    Time frame: 3 Months

  2. Satisfaction with Care measured by Diabetes Treatment Satisfaction Questionnaire (DTSQ).

    Time frame: 3 Months

  3. Adherence to the diabetes self-management regimen using the Diabetes Self Management Questionnaire (DSMQ).

    Time frame: 3 Months

  4. Acceptability of the intervention protocol will be evaluated using a satisfaction survey.

    Time frame: 3 Months

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 1, 2016
Registry last updated
May 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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