AzTrials
AzTrials

Diabetes MellitusTExTMEDFANSNCT01945996

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

A study testing TExT MED and FANS in people with Diabetes Mellitus, run by University of Southern California at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus
What is being tested?
TExT MED and FANS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteUnited States
Study dates
Sep 2013to May 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • unable to consent
  • pediatric patient

Trial locations and contacts

1 site in 1 country.

United States1 site

  • LAC+USC

    Los Angeles, California, 90033

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
TExT MED, FANS
Keywords
Hispanic Americans, Cellular Phone, Behavior
Medical subject headings
Diabetes Mellitus, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TExT MEDBehavioural

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

  • FANSBehavioural

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

Study groups in NCT01945996
Study groupRoleWhat they receive
TExT-MED onlyActive comparatorPatients will receive TExT-MED intervention, but supporters will not receive additional messages
Receives: Behavioral: TExT MED
TExT-MED FANSExperimentalPatients get TExT-MED intervention, supporter gets FANS curriculum
Receives: Behavioral: TExT MED; Behavioral: FANS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility

    Number of patients lost to follow-up

    Measured: 3 months after enrollment

  2. 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?

    Measured: 3 months after enrollment

  3. Acceptability 2: Would Patients Recommend the Program to Family or Friends?

    Response to: Would you recommend TExT-MED FANS to family or friends?

    Measured: 3 months follow up

Secondary outcomes (11)

  1. Diabetes Knowledge Test Scale

    Diabetes Knowledge Test Scale measures specific areas of diabetes knowledge, and is geared to specific curriculum

    Measured: 3 months after enrollment

  2. 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

    Measured: 3 months after enrollment

  3. 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

    Measured: 3 months after enrollment

  4. Glycemic Control

    glycosylated hemoglobin A1c

    Measured: 3 months after enrollment

  5. Body Mass Index

    height and weight measurements

    Measured: 3 months after enrollment

  6. 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)

    Measured: 3 months follow up

  7. 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)

    Measured: 3 months follow up

  8. 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)

    Measured: 3 months follow up

  9. 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)

    Measured: 3 months follow up

  10. 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)

    Measured: 3 months follow up

  11. 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)

    Measured: 3 months follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionMay 2014
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01945996
Sponsor's protocol ID
HS-13-00382
Other IDs
KL2TR000131
Acronym
TExTMEDFANS
Status last verified
Mar 2018
First submitted
30 Aug 2013
Last updated
6 Nov 2018
Data monitoring committee
No

Publications

  • 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.

    PubMed 23439166

  • 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.

    PubMed 22524591

Questions about this trial

What is this clinical trial studying?

A study testing TExT MED and FANS in people with Diabetes Mellitus, run by University of Southern California at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility (time frame: 3 months after enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01945996, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2018.

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