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

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Behavioral: TExT MED; Behavioral: FANS

• Registration Number: NCT01945996
• Lead Sponsor: University of Southern California

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.

Study Timeline

• Study First Submitted: 2013-08-30
• Study Start: 2013-09
• Study First Submitted QC: 2013-09-16
• Study First Posted: 2013-09-19
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Results First Submitted: 2017-05-26
• Status Verified: 2018-03
• Results First Submitted QC: 2018-03-06
• Last Update Submitted: 2018-03-06
• Results First Posted: 2018-11-06
• Last Update Posted: 2018-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

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

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Exclusion Criteria

• unable to consent
• pediatric patient

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TExT-MED FANS	FANS	Patients get TExT-MED intervention, supporter gets FANS curriculum
TExT-MED only	TExT MED	Patients will receive TExT-MED intervention, but supporters will not receive additional messages
TExT-MED FANS	TExT MED	Patients get TExT-MED intervention, supporter gets FANS curriculum

Primary Outcome Measures

Name	Time	Method
Acceptability 2: Would Patients Recommend the Program to Family or Friends?	3 months follow up	Response to: Would you recommend TExT-MED FANS to family or friends?
Feasibility	3 months after enrollment	Number of patients lost to follow-up
Acceptability	3 months after enrollment	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?

Secondary Outcome Measures

Name	Time	Method
Change in Problem Areas in Diabetes Scale	3 months after enrollment	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
Body Mass Index	3 months after enrollment	height and weight measurements
Diabetes Knowledge Test Scale	3 months after enrollment	Diabetes Knowledge Test Scale measures specific areas of diabetes knowledge, and is geared to specific curriculum
Change in Self-efficacy	3 months after enrollment	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
Change in Summary of Diabetes Self-care Activities - Blood Glucose Sub Score	3 months follow up	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)
Change in Summary of Diabetes Self-care Activities - Carb Spacing Sub Score	3 months follow up	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)
Change in Summary of Diabetes Self-care Activities - General Diet Sub Score	3 months follow up	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)
Change in Summary of Diabetes Self-care Activities - Exercise Sub Score	3 months follow up	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)
Glycemic Control	3 months after enrollment	glycosylated hemoglobin A1c
Change in Summary of Diabetes Self-care Activities - Foot Care Sub Score	3 months follow up	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)
Change in Summary of Diabetes Self-care Activities - Specific Diet Sub Score	3 months follow up	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)

Trial Locations

Locations (1)

LAC+USC; 🇺🇸 Los Angeles, California, United States