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

NCT ID: NCT01945996

Last Updated: 2018-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2014-05-31

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

TExT-MED only

Patients will receive TExT-MED intervention, but supporters will not receive additional messages

Group Type: ACTIVE_COMPARATOR

TExT MED

Intervention Type: BEHAVIORAL

educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone

TExT-MED FANS

Patients get TExT-MED intervention, supporter gets FANS curriculum

Group Type: EXPERIMENTAL

TExT MED

Intervention Type: BEHAVIORAL

educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone

FANS

Intervention Type: BEHAVIORAL

supporter curriculum of messages, consisting of educational/motivational messages, and support challenges

Interventions

TExT MED

educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone

Intervention Type: BEHAVIORAL

FANS

supporter curriculum of messages, consisting of educational/motivational messages, and support challenges

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Burner

Assistant Professor of Clinical Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

LAC+USC

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23439166 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22524591 (View on PubMed)

Other Identifiers

KL2TR000131

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HS-13-00382

Identifier Type: -

Identifier Source: org_study_id