Harnessing mHealth and Social Support to Improve Diabetes Related Health Behavior for Inner-city Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Trial to Examine Text-based mHealth for Emergency Department Patients With Diabetes With Family And Friend Network Supporter

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Behavioral: TExT MED
* Behavioral: FANS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TExT-MED only<br>Patients will receive TExT-MED intervention, but supporters will not receive additional messages | Behavioral: TExT MED<br>* educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone<br>|
| Experimental: TExT-MED FANS<br>Patients get TExT-MED intervention, supporter gets FANS curriculum | Behavioral: TExT MED<br>* educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone<br>Behavioral: FANS<br>* supporter curriculum of messages, consisting of educational/motivational messages, and support challenges<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility | Number of patients lost to follow-up | 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? | 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? | 3 months follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes Knowledge Test Scale | Diabetes Knowledge Test Scale measures specific areas of diabetes knowledge, and is geared to specific curriculum | 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 | 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 | 3 months after enrollment | 
| Glycemic Control | glycosylated hemoglobin A1c | 3 months after enrollment | 
| Body Mass Index | height and weight measurements | 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) | 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) | 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) | 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) | 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) | 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) | 3 months follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hispanic Americans, Cellular Phone, Behavior