Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02049359 |
| Other study ID # |
49 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2014 |
| Est. completion date |
March 2016 |
Study information
| Verified date |
August 2022 |
| Source |
Campbell University, Incorporated |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
