Clinical trial NCT01945996: Harnessing mHealth and Social Support to Improve Diabetes Related Health Behavior for Inner-city Patients
Official title: Trial to Examine Text-based mHealth for Emergency Department Patients With Diabetes With Family And Friend Network Supporter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Hispanic Americans
Cellular Phone
Behavior
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2013-09-19
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study, an existing mobile health intervention to improve diabetes self-management will be combined with a social support module and tested for feasibility. The investigators hypothesize that this combination will be feasible and acceptable to both patients and their loved ones.

Detailed description: This will be the first ever evaluation of a highly scalable and low-cost social support intervention for patients with diabetes delivered entirely via mobile phones. TExT-MED FANS (Trial to Examine Text-based mHealth for Emergency Department Patients With Diabetes With Family And Friend Network Supporter) will unite the benefits of mHealth (scalability, ease of access) and social support interventions (personalized motivation, emotional support). The Diabetes FANS text message based curriculum will make it easier for friends and family to become supporters. Additionally, augmenting TExT-MED with the FANS social support module will be more effective than TExT-MED alone. The personalized support of TExT-MED FANS will also be more effective than providing TExT-MED in combination with a community health worker supporter who lacks a pre-existing relationship with the patient. Through this innovative combination, I can create a more cost-effective and diffusible mHealth solution that maintains the personal connection of social support interventions. To date there has only been one study evaluating social support interventions for patients with diabetes using mHealth, but in this study participants were paired with other subjects with diabetes (not friends or family) and it required intensive face-to-face support group time. TExT-MED FANS will provide key insights into the utility of combining social support interventions delivered solely via mHealth in low-income Latino patients. These insights will help future interventions achieve maximal impact on diabetes and other chronic disease management.

Eligibility criteria: Inclusion Criteria:

* type II diabetes
* HbA1c \>or=8 at enrollment
* speak English or Spanish
* has support person willing to participate

Exclusion Criteria:

* unable to consent
* pediatric patient

Primary outcomes:
measure: Feasibility
timeFrame: 3 months after enrollment
measure: Acceptability
timeFrame: 3 months after enrollment
measure: Acceptability 2: Would Patients Recommend the Program to Family or Friends?
timeFrame: 3 months follow up
Secondary outcomes:
measure: Diabetes Knowledge Test Scale
timeFrame: 3 months after enrollment
measure: Change in Self-efficacy
timeFrame: 3 months after enrollment
measure: Change in Problem Areas in Diabetes Scale
timeFrame: 3 months after enrollment
measure: Glycemic Control
timeFrame: 3 months after enrollment
measure: Body Mass Index
timeFrame: 3 months after enrollment
measure: Change in Summary of Diabetes Self-care Activities - General Diet Sub Score
timeFrame: 3 months follow up
measure: Change in Summary of Diabetes Self-care Activities - Specific Diet Sub Score
timeFrame: 3 months follow up
measure: Change in Summary of Diabetes Self-care Activities - Exercise Sub Score
timeFrame: 3 months follow up
measure: Change in Summary of Diabetes Self-care Activities - Blood Glucose Sub Score
timeFrame: 3 months follow up
measure: Change in Summary of Diabetes Self-care Activities - Foot Care Sub Score
timeFrame: 3 months follow up
measure: Change in Summary of Diabetes Self-care Activities - Carb Spacing Sub Score
timeFrame: 3 months follow up
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: LAC+USC
state: California
Study officials:
References:
citation: Burner E, Menchine M, Taylor E, Arora S. Gender differences in diabetes self-management: a mixed-methods analysis of a mobile health intervention for inner-city Latino patients. J Diabetes Sci Technol. 2013 Jan 1;7(1):111-8. doi: 10.1177/193229681300700113.
citation: Arora S, Peters AL, Agy C, Menchine M. A mobile health intervention for inner city patients with poorly controlled diabetes: proof-of-concept of the TExT-MED program. Diabetes Technol Ther. 2012 Jun;14(6):492-6. doi: 10.1089/dia.2011.0252. Epub 2012 Apr 23.