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

Diabetes Mellitus Clinical Trial

— TExTMEDFANS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01945996
• Other study ID #: HS-13-00382
• Secondary ID: KL2TR000131
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: May 2014

Study information

• Verified date: March 2018
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Behavioral:
• TExT MED
educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone
• FANS
supporter curriculum of messages, consisting of educational/motivational messages, and support challenges

Locations

Country	Name	City	State
United States	LAC+USC	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	Number of patients lost to follow-up	3 months after enrollment
Primary	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
Primary	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	Diabetes Knowledge Test Scale	Diabetes Knowledge Test Scale measures specific areas of diabetes knowledge, and is geared to specific curriculum	3 months after enrollment
Secondary	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
Secondary	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
Secondary	Glycemic Control	glycosylated hemoglobin A1c	3 months after enrollment
Secondary	Body Mass Index	height and weight measurements	3 months after enrollment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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