Short Messaging Service for Optimizing Hemoglobin A1C Management in Low-Income Diabetics

NCT ID: NCT02049359

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-03-31

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.

Detailed Description

This multi-center, unblinded, prospective randomized controlled trial will enroll adult diabetic patients of the Wilson Community Health Center, Harvest Family Health Center, and Freedom Hill Community Health Center living below 200% of 2013 poverty level with a serum hemoglobin A1C >9% and who currently own a mobile device with text messaging capacity. After written informed consent has been obtained, subjects will be randomized to intervention or control group (1:1), stratified based on insulin initiation within 1 week of study inclusion. Participants randomized to the intervention group will be further divided into subgroups as "insulin user" or "non-insulin user" and both will receive SMS messages every 7 days. The content of the message consist of medication reminders, reporting of blood glucose results, insulin technique assessment (if applicable), or d) medication adherence assessment. Participants will be asked to respond with a simple text within 7 days. The intervention group will receive the standard medical appointment reminder via telephone one to two business days prior to the appointment at the Health Center PLUS a unidirectional text message two business days prior to scheduled health center appointments. Control group participants will receive the standard medical appointment reminder via telephone one to two business days prior to the appointment at the health center. All participants in the study (control and intervention) will undergo venipuncture at 3 months (+/-) 2 weeks for the determination of hemoglobin A1C. Demographic information, and frequency of hemoglobin A1C concentrations in the past 6 months will be assessed at baseline. Each week for 12 weeks, the number of texts sent per week and by type, percent of respondents weekly by text or by phone, content of participant responses, number of patients unable to be reached via text, total investigator time spent per week, and time spent per contact will be recorded. At the three month visit, the hemoglobin A1C concentration, blood transfusions since study initiation, and medication changes will be recorded.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control group

Care as usual; no bidirectional texting

Group Type: NO_INTERVENTION

No interventions assigned to this group

Texting

Bidirectional texting weekly for 12 weeks

Group Type: EXPERIMENTAL

Texting

Intervention Type: OTHER

Bidirectional texting once weekly for 12 weeks

Interventions

Texting

Bidirectional texting once weekly for 12 weeks

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Campbell University, Incorporated

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer D Smith, PharmD

Role: PRINCIPAL_INVESTIGATOR

Campbell University/Wilson Community Health Center

Richard Drew, PharmD

Role: STUDY_DIRECTOR

Campbell University/Duke University

Locations

Harvest Family Health Center

Elm City, North Carolina, United States

Freedom Hill Community Health Center

Tarboro, North Carolina, United States

Wilson Community Health Center

Wilson, North Carolina, United States

Countries

United States

Other Identifiers

49

Identifier Type: -

Identifier Source: org_study_id