NCT02726217

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2017

Completed
Last Updated

May 5, 2017

Status Verified

May 1, 2017

Enrollment Period

1.2 years

First QC Date

March 29, 2016

Last Update Submit

May 4, 2017

Conditions

DiabetesType 2 Diabetes (T2D)

Keywords

CareSmartsSMS-based mobile

Outcome Measures

Primary Outcomes (4)

  • Measure of glucose

    3 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

Study Arms (2)

CareSmarts Intervention

EXPERIMENTAL

Participants in the program receive text messages about diabetes self-care

Behavioral: CareSmarts Mobile Health Diabetes ProgramBehavioral: Standard of Care Reminders and Self Assessments

Control

ACTIVE COMPARATOR

Standard of Care reminders and assessments for individuals with Diabetes

Behavioral: Standard of Care Reminders and Self Assessments

Interventions

CareSmarts Mobile Health Diabetes ProgramBEHAVIORAL

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.

CareSmarts Intervention
Standard of Care Reminders and Self AssessmentsBEHAVIORAL
CareSmarts InterventionControl

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

Diagnostic Self Evaluation

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Mary Sevick, MD

    New York University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2016

First Posted

April 1, 2016

Study Start

March 1, 2016

Primary Completion

May 2, 2017

Study Completion

May 2, 2017

Last Updated

May 5, 2017

Record last verified: 2017-05

Locations

US(1)