NCT01945996

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 19, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

November 6, 2018

Completed
Last Updated

November 6, 2018

Status Verified

March 1, 2018

Enrollment Period

8 months

First QC Date

August 30, 2013

Results QC Date

May 26, 2017

Last Update Submit

March 6, 2018

Conditions

Diabetes Mellitus

Keywords

Hispanic AmericansCellular PhoneBehavior

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (11)

  • Diabetes Knowledge Test Scale

    3 months after enrollment

  • Change in Self-efficacy

    3 months after enrollment

  • Change in Problem Areas in Diabetes Scale

    3 months after enrollment

  • Glycemic Control

    3 months after enrollment

  • Body Mass Index

    3 months after enrollment

  • +6 more secondary outcomes

Study Arms (2)

TExT-MED only

ACTIVE COMPARATOR

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

Behavioral: TExT MED

TExT-MED FANS

EXPERIMENTAL

Patients get TExT-MED intervention, supporter gets FANS curriculum

Behavioral: TExT MEDBehavioral: FANS

Interventions

TExT MEDBEHAVIORAL

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

TExT-MED FANSTExT-MED only
FANSBEHAVIORAL

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

TExT-MED FANS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • unable to consent
  • pediatric patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LAC+USC

Los Angeles, California, 90033, United States

Location

Related Publications (2)

  • 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.

    PMID: 23439166BACKGROUND

  • 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.

    PMID: 22524591BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusBehavior

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Limitations and Caveats

BMI was not able to be collected. Diabetes knowledge test was removed from follow up as intervention did not teach sufficient content to overlap with scale Unable to measure actual text receipt on the mobile platform used

Results Point of Contact

Title
Elizabeth Burner
Organization
University of Southern California
eburner@usc.edu
3232266667

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Clinical Emergency Medicine

Study Record Dates

First Submitted

August 30, 2013

First Posted

September 19, 2013

Study Start

September 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

November 6, 2018

Results First Posted

November 6, 2018

Record last verified: 2018-03

Locations

US(1)