NCT02049359

Brief Summary

The purpose of this study is to determine the impact of two-way short message service (SMS) on glycemic control in low-income, poorly-controlled adult diabetic patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable diabetes

Geographic Reach
1 country

3 active sites

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

January 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
7.3 years until next milestone

Results Posted

Study results publicly available

July 3, 2023

Completed
Last Updated

July 3, 2023

Status Verified

August 1, 2022

Enrollment Period

2.2 years

First QC Date

January 28, 2014

Results QC Date

July 18, 2017

Last Update Submit

August 5, 2022

Conditions

Keywords

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline A1C

    Change in A1C from baseline

    12 weeks

Secondary Outcomes (1)

  • Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes

    12 weeks

Study Arms (2)

Control group

NO INTERVENTION

Care as usual; no bidirectional texting

Texting

EXPERIMENTAL

Bidirectional texting weekly for 12 weeks

Other: Texting

Interventions

TextingOTHER

Bidirectional texting once weekly for 12 weeks

Texting

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • New or existing patient of Carolina Family Health Centers Inc. (Wilson Community Health Center, Harvest Family Health Center, Freedom Hill Community Health Center)
  • Diagnosis of diabetes
  • Single serum hemoglobin A1C equal to or greater than 9% within 2 weeks of study enrollment
  • Below 200% of 2013 poverty level
  • Currently own a mobile device with text messaging capacity and anticipated service for duration of 12 week study period

You may not qualify if:

  • Anemia diagnosed within past 3 months
  • Blood transfusion within the past 3 months
  • unable to read English at the fifth grade level

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Harvest Family Health Center

Elm City, North Carolina, 27822, United States

Location

Freedom Hill Community Health Center

Tarboro, North Carolina, 27886, United States

Location

Wilson Community Health Center

Wilson, North Carolina, 27893, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Jennifer Smith
Organization
Campbell University

Study Officials

  • Jennifer D Smith, PharmD

    Campbell University/Wilson Community Health Center

    PRINCIPAL INVESTIGATOR
  • Richard Drew, PharmD

    Campbell University/Duke University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2014

First Posted

January 30, 2014

Study Start

January 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

July 3, 2023

Results First Posted

July 3, 2023

Record last verified: 2022-08

Locations