Clinical trial NCT03178773: TExT-MED + FANS Full Trial
Official title: Trial to EXamine Text Messaging for Diabetes in ED Patients Incorporating Social Support - Intervention With Washout
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Keywords: mobile health
social support
health disparity
Latino
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2017-06-07
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* Age \>18
* HbA1c\>8.5
* Social support person identified and contacted

Exclusion Criteria:

* unable to consent
* does not speak/read English or Spanish

Primary outcomes:
measure: Change in HBA1c From Baseline
timeFrame: 6 Months
Secondary outcomes:
measure: Change in HBA1c From 6 Months to 12 Months
timeFrame: 12 months
measure: Change in BMI From Baseline
timeFrame: 6 Months
measure: Change in BMI From 6 Months to 12 Months
timeFrame: 12 Months
measure: Change in Abdominal Circumference From Baseline
timeFrame: 6 Months
measure: Change From Abdominal Circumference From 6 Months to 12 Months
timeFrame: 12 Months
measure: Change in Systolic Blood Pressure From Baseline
timeFrame: 6 Months
measure: Change in Systolic Blood Pressure From 6 Months to 12 Months
timeFrame: 12 Months
measure: Change in Diastolic Blood Pressure From Baseline
timeFrame: 6 Months
measure: Change in Diastolic Blood Pressure From 6 Months to 12 Months
timeFrame: 12 Months
measure: Change in Summary of Diabetes Self-care Activities From Baseline
timeFrame: 6 Months
measure: Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months
timeFrame: 12 Months
measure: Change in Wilson 3 Item Scale From Baseline
timeFrame: 6 Months
measure: Change in Wilson 3 Item Scale From 6 Months to 12 Months
timeFrame: 12 Months
measure: Change in Healthcare Utilization From Baseline
timeFrame: 6 Months
measure: Change in Healthcare Utilization From 6 Months to 12 Months
timeFrame: 12 Months
measure: Change in Diabetes Empowerment Scale Short Form From Baseline
timeFrame: 6 Months
measure: Change in Diabetes Empowerment Scale Short Form From 6 Months to 12 Months
timeFrame: 12 months
measure: Change in Diabetes Distress Scale From Baseline
timeFrame: 6 Months
measure: Change in Diabetes Distress Scale From 6 Months to 12 Months
timeFrame: 12 Months
measure: Change in Patient Health Questionnaire 9 From Baseline
timeFrame: 6 Months
measure: Change in Patient Health Questionnaire 9 From 6 Months to 12 Months
timeFrame: 12 Months
measure: Change in Fatalism From Baseline
timeFrame: 6 Months
measure: Change in Fatalism From 6 Months to 12 Months
timeFrame: 12 Months
measure: Change in WHO Quality of Life From Baseline
timeFrame: 6 Months
measure: Change in WHO Quality of Life From 6 Months to 12 Months
timeFrame: 12 Months
measure: Change in Diabetes Family Behavior Checklist - Supportive From Baseline
timeFrame: 6 Months
measure: Change in Diabetes Family Behavior Checklist Supportive From 6 Months to 12 Months
timeFrame: 12 Months
measure: Change in Diabetes Family Behavior Checklist - Nonsupportive From Baseline
timeFrame: 6 Months
measure: Change in Diabetes Family Behavior Checklist Nonsupportive From 6 Months to 12 Months
timeFrame: 12 Months
measure: Change in Diabetes Care Profile Support From Baseline
timeFrame: 6 Months
measure: Change in Diabetes Care Profile Support From 6 Months to 12 Months
timeFrame: 12 Months
measure: Change in Norbeck Social Support Questionnaire From Baseline
timeFrame: 6 Months
measure: Change in Norbeck Social Support Questionnaire From 6 Months to 12 Months
timeFrame: 12 Months
measure: Change in Partner Distress Scale From Baseline
timeFrame: 6 Months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: LAC+USC Medicine Center Emergency Department
state: California
Study officials:
References: