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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Behavioral: TExT MED; Behavioral: FANS

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • LAC+USC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Southern California

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: August 30, 2013
• First Submitted That Met QC Criteria: September 16, 2013
• First Posted (Estimate): September 19, 2013

Study Record Updates

• Last Update Posted (Actual): November 6, 2018
• Last Update Submitted That Met QC Criteria: March 6, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Behavior; Cellular Phone; Hispanic Americans
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: HS-13-00382; KL2TR000131 (U.S. NIH Grant/Contract)