Trial to EXamine Text Messaging for Diabetes in ED Patients Incorporating Social Support - Intervention With Washout
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 166
- Locations
- 1
- Primary Endpoint
- Change in HBA1c From Baseline
Study Overview
Brief Summary
This is an intervention to study incorporating social support into mHealth interventions for low-income, ED patients with diabetes
Detailed Description
Diabetes has disproportionately affected the Latino population. TExT-MED (Trial to Examine Text Message for Emergency Department Patients with Diabetes) is a locally designed, successful mobile health (mHealth) intervention for low income Latinos with diabetes. Social support interventions have likewise been successful at improving patient self-efficacy and disease management but are limited in scale due to two key obstacles: 1) requirements of in-person training of family and friends to be supporters and 2) the need to coordinate schedules and physical location between the patient and their supporter. mHealth can overcome these obstacles by allowing supporters to be trained remotely via a mobile platform and by allowing communication between a patient and supporter to occur at any time or place. The proposed intervention leverages the success of TExT-MED by augmenting the program with a social supporter that each patient can select from his or her own social support system (Family And friend Network Supporters (FANS)), creating TExT-MED+FANS. This is a 12 month, randomized study of this intervention. At the completion of the trial, we will evaluate the user experience with TExT-MED+FANS, and the impact of TExT-MED+FANS on patient motivation, self-efficacy and behaviors through a qualitative analysis of semi-structured individual interviews.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •HbA1c>8.5
- •Social support person identified and contacted
Exclusion Criteria
- •unable to consent
- •does not speak/read English or Spanish
Arms & Interventions
TExT-MED only
Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form.
Intervention: TExT-MED (Behavioral)
TExT-MED+FANS
Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content.
Intervention: TExT-MED (Behavioral)
TExT-MED+FANS
Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content.
Intervention: FANS (Behavioral)
Outcomes
Primary Outcomes
Change in HBA1c From Baseline
Time Frame: 6 Months
Glycemic control is measured by hemoglobin A1C collected at point-of-care from an Afinion AS100 capillary point of care machine. The Afinion machine has excellent point of care correlation with laboratory values. As a surrogate for average glycemic control over the previous 3 months and with correlation with clinical outcomes, hemoglobin A1c is a marker of overall clinical disease management. Change is baseline value minus follow up value.
Secondary Outcomes
- Change in Diabetes Care Profile Support From Baseline(6 Months)
- Change in Fatalism From Baseline(6 Months)
- Change in Healthcare Utilization From 6 Months to 12 Months(12 Months)
- Change in HBA1c From 6 Months to 12 Months(12 months)
- Change in BMI From 6 Months to 12 Months(12 Months)
- Change in Systolic Blood Pressure From Baseline(6 Months)
- Change in Diastolic Blood Pressure From Baseline(6 Months)
- Change in Abdominal Circumference From Baseline(6 Months)
- Change From Abdominal Circumference From 6 Months to 12 Months(12 Months)
- Change in BMI From Baseline(6 Months)
- Change in Systolic Blood Pressure From 6 Months to 12 Months(12 Months)
- Change in Diastolic Blood Pressure From 6 Months to 12 Months(12 Months)
- Change in Summary of Diabetes Self-care Activities From Baseline(6 Months)
- Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months(12 Months)
- Change in Wilson 3 Item Scale From Baseline(6 Months)
- Change in Healthcare Utilization From Baseline(6 Months)
- Change in Fatalism From 6 Months to 12 Months(12 Months)
- Change in WHO Quality of Life From Baseline(6 Months)
- Change in Norbeck Social Support Questionnaire From Baseline(6 Months)
- Change in Wilson 3 Item Scale From 6 Months to 12 Months(12 Months)
- Change in Diabetes Distress Scale From Baseline(6 Months)
- Change in Diabetes Family Behavior Checklist Nonsupportive From 6 Months to 12 Months(12 Months)
- Change in Diabetes Care Profile Support From 6 Months to 12 Months(12 Months)
- Change in Diabetes Empowerment Scale Short Form From Baseline(6 Months)
- Change in Diabetes Distress Scale From 6 Months to 12 Months(12 Months)
- Change in Patient Health Questionnaire 9 From 6 Months to 12 Months(12 Months)
- Change in Diabetes Family Behavior Checklist - Supportive From Baseline(6 Months)
- Change in Diabetes Family Behavior Checklist Supportive From 6 Months to 12 Months(12 Months)
- Change in Diabetes Empowerment Scale Short Form From 6 Months to 12 Months(12 months)
- Change in WHO Quality of Life From 6 Months to 12 Months(12 Months)
- Change in Diabetes Family Behavior Checklist - Nonsupportive From Baseline(6 Months)
- Change in Norbeck Social Support Questionnaire From 6 Months to 12 Months(12 Months)
- Change in Patient Health Questionnaire 9 From Baseline(6 Months)
- Change in Partner Distress Scale From Baseline(6 Months)
Investigators
Elizabeth Burner
Assistant Professor of Clinical Emergency Medicine
University of Southern California