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Completed

NCT Number: NCT01945996

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

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.

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Key information

Conditions

Diabetes Mellitus Behavior Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LAC+USC

Los Angeles, California, 90033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TExT MED

Behavioral

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

FANS

Behavioral

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

Primary outcomes

  1. Feasibility

    Time frame: 3 months after enrollment

    Number of patients lost to follow-up

  2. Acceptability

    Time frame: 3 months after enrollment

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

    Time frame: 3 months follow up

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

Secondary outcomes

  1. Diabetes Knowledge Test Scale

    Time frame: 3 months after enrollment

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

  2. Change in Self-efficacy

    Time frame: 3 months after enrollment

    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. Change in Problem Areas in Diabetes Scale

    Time frame: 3 months after enrollment

    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

  4. Glycemic Control

    Time frame: 3 months after enrollment

    glycosylated hemoglobin A1c

  5. Body Mass Index

    Time frame: 3 months after enrollment

    height and weight measurements

  6. Change in Summary of Diabetes Self-care Activities - General Diet Sub Score

    Time frame: 3 months follow up

    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)

  7. Change in Summary of Diabetes Self-care Activities - Specific Diet Sub Score

    Time frame: 3 months follow up

    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)

  8. Change in Summary of Diabetes Self-care Activities - Exercise Sub Score

    Time frame: 3 months follow up

    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)

  9. Change in Summary of Diabetes Self-care Activities - Blood Glucose Sub Score

    Time frame: 3 months follow up

    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)

  10. Change in Summary of Diabetes Self-care Activities - Foot Care Sub Score

    Time frame: 3 months follow up

    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)

  11. Change in Summary of Diabetes Self-care Activities - Carb Spacing Sub Score

    Time frame: 3 months follow up

    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)

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

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

Acronym: TExTMEDFANS

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 19, 2013
Registry last updated
Nov 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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