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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
44
LAC+USC
Los Angeles, California, United States
Feasibility
Number of patients lost to follow-up
Time frame: 3 months after enrollment
Acceptability
Patient response to: I have enjoyed the TExT-MED FANS (Trial to Examine Text-based mHealth for Emergency Department Patients With Diabetes With Family And Friend Network Supporter) program?
Time frame: 3 months after enrollment
Acceptability 2: Would Patients Recommend the Program to Family or Friends?
Response to: Would you recommend TExT-MED FANS to family or friends?
Time frame: 3 months follow up
Diabetes Knowledge Test Scale
Diabetes Knowledge Test Scale measures specific areas of diabetes knowledge, and is geared to specific curriculum
Time frame: 3 months after enrollment
Change in Self-efficacy
Change Diabetes Empowerment Scale - Short Form( measures feelings of self efficacy regarding diabetes disease management) from baseline to 6 month follow up scale minimum 8, maximum 40 Best possible change 40 (maximum at follow up) minus 8 (minimum at follow up)=32 Worst possible change: -32
Time frame: 3 months after enrollment
Change in Problem Areas in Diabetes Scale
Change in Problem areas in diabetes scale (a measure of mental health problems that patient experience related to their diabetes) Baseline minus 3 month follow up. Higher score = more problems scale minimum 0 scale maximum 100 worst possible change -100 (0 problem scale at baseline, 100 at follow up) best possible change 100 (100 problem scale at baseline, 0 at follow up
Time frame: 3 months after enrollment
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Glycemic Control
glycosylated hemoglobin A1c
Time frame: 3 months after enrollment
Body Mass Index
height and weight measurements
Time frame: 3 months after enrollment
Change in Summary of Diabetes Self-care Activities - General Diet Sub Score
change in number of days patient followed a general diet plan (3 month follow up report minus baseline report) Minimum -7: worst possible change (from all days at baseline to no days at follow up) Max 7: best possible change from baseline (from no days at baseline to all days at follow up)
Time frame: 3 months follow up
Change in Summary of Diabetes Self-care Activities - Specific Diet Sub Score
change in number of days patient followed a diabetes specific diet plan (3 month follow up report minus baseline report) Minimum -7: worst possible change (from all days at baseline to no days at follow up) Max 7: best possible change from baseline (from no days at baseline to all days at follow up)
Time frame: 3 months follow up
Change in Summary of Diabetes Self-care Activities - Exercise Sub Score
change in number of days patient exercised (3 month follow up report minus baseline report) Minimum -7: worst possible change (from all days at baseline to no days at follow up) Max 7: best possible change from baseline (from no days at baseline to all days at follow up)
Time frame: 3 months follow up
Change in Summary of Diabetes Self-care Activities - Blood Glucose Sub Score
change in number of days patient checked blood sugar (3 month follow up report minus baseline report) Minimum -7: worst possible change (from all days at baseline to no days at follow up) Max 7: best possible change from baseline (from no days at baseline to all days at follow up)
Time frame: 3 months follow up
Change in Summary of Diabetes Self-care Activities - Foot Care Sub Score
change in number of days patient followed a foot care plan (3 month follow up report minus baseline report) Minimum -7: worst possible change (from all days at baseline to no days at follow up) Max 7: best possible change from baseline (from no days at baseline to all days at follow up)
Time frame: 3 months follow up
Change in Summary of Diabetes Self-care Activities - Carb Spacing Sub Score
change in number of days patient followed a carb spacing plan (3 month follow up report minus baseline report) Minimum -7: worst possible change (from all days at baseline to no days at follow up) Max 7: best possible change from baseline (from no days at baseline to all days at follow up)
Time frame: 3 months follow up