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DiabetesPhase 2TExTMED+FANSIINCT03178773

TExT-MED + FANS Full Trial

A Phase 2 study testing TExT-MED and FANS in people with Diabetes, 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

This is an intervention to study incorporating social support into mHealth interventions for low-income, ED patients with diabetes Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes
What is being tested?
TExT-MED and FANS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
166 participants
Where
1 siteUnited States
Study dates
18 Jul 2017to 2 Dec 2019
Phase
Phase 2
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

  • Age >18
  • HbA1c>8.5
  • Social support person identified and contacted

Who cannot join

  • unable to consent
  • does not speak/read English or Spanish

Trial locations and contacts

1 site in 1 country.

United States1 site
  • LAC+USC Medicine Center Emergency Department

    Los Angeles, California, 90033

Other trials in United States

About this study

Official title: Trial to EXamine Text Messaging for Diabetes in ED Patients Incorporating Social Support - Intervention With Washout

This is an intervention to study incorporating social support into mHealth interventions for low-income, ED patients with diabetes

Read the detailed description

Diabetes has disproportionately affected the Latino population. TExT-MED (Trial to Examine Text Message for Emergency Department Patients with Diabetes) is a locally designed, successful mobile health (mHealth) intervention for low income Latinos with diabetes. Social support interventions have likewise been successful at improving patient self-efficacy and disease management but are limited in scale due to two key obstacles: 1) requirements of in-person training of family and friends to be supporters and 2) the need to coordinate schedules and physical location between the patient and their supporter. mHealth can overcome these obstacles by allowing supporters to be trained remotely via a mobile platform and by allowing communication between a patient and supporter to occur at any time or place. The proposed intervention leverages the success of TExT-MED by augmenting the program with a social supporter that each patient can select from his or her own social support system (Family And friend Network Supporters (FANS)), creating TExT-MED+FANS. This is a 12 month, randomized study of this intervention. At the completion of the trial, we will evaluate the user experience with TExT-MED+FANS, and the impact of TExT-MED+FANS on patient motivation, self-efficacy and behaviors through a qualitative analysis of semi-structured individual interviews.

Conditions
Diabetes
Being tested
TExT-MED, FANS
Keywords
mobile health, social support, health disparity, Latino
Medical subject headings
Diabetes Mellitus

What participants receive

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

  • TExT-MEDBehavioural

    messages designed to inspire motivation and behavior change

  • FANSBehavioural

    SMS delivered messages to family members to improve social support

Study groups in NCT03178773
Study groupRoleWhat they receive
TExT-MED onlyActive comparatorPatients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form.
Receives: Behavioral: TExT-MED
TExT-MED+FANSExperimentalPatients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content.
Receives: Behavioral: TExT-MED; Behavioral: FANS

What is being measured

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

  1. Change in HBA1c From Baseline

    Glycemic control is measured by hemoglobin A1C collected at point-of-care from an Afinion AS100 capillary point of care machine. The Afinion machine has excellent point of care correlation with laboratory values. As a surrogate for average glycemic control over the previous 3 months and with correlation with clinical outcomes, hemoglobin A1c is a marker of overall clinical disease management. Change is baseline value minus follow up value.

    Measured: 6 Months

Secondary outcomes (34)
  1. Change in HBA1c From 6 Months to 12 Months

    Glycemic control is measured by hemoglobin A1C collected at point-of-care from an Afinion AS100 capillary point of care machine. The Afinion machine has excellent point of care correlation with laboratory values. As a surrogate for average glycemic control over the previous 3 months and with correlation with clinical outcomes, hemoglobin A1c is a marker of overall clinical disease management. Change is 6 month value minus 12 month value.

    Measured: 12 months

  2. Change in BMI From Baseline

    Calculated from Weight and Height. As a measure of adiposity, it correlates positively with cardiovascular disease outcomes. While imperfect, it is an easily measured and validated marker.

    Measured: 6 Months

  3. Change in BMI From 6 Months to 12 Months

    Calculated from Weight and Height. As a measure of adiposity, it correlates positively with cardiovascular disease outcomes. While imperfect, it is an easily measured and validated marker.

    Measured: 12 Months

  4. Change in Abdominal Circumference From Baseline

    A measure of central adiposity, it correlates with cardiovascular outcomes.

    Measured: 6 Months

  5. Change From Abdominal Circumference From 6 Months to 12 Months

    A measure of central adiposity, it correlates with cardiovascular outcomes.

    Measured: 12 Months

  6. Change in Systolic Blood Pressure From Baseline

    Blood pressure is measured by study RAs after the patient is seated for 5 minutes, with the average of three readings used as the systolic blood pressure for that visit. Systolic blood pressure is associated with cardiovascular complications

    Measured: 6 Months

  7. Change in Systolic Blood Pressure From 6 Months to 12 Months

    Blood pressure is measured by study RAs after the patient is seated for 5 minutes, with the average of three readings used as the systolic blood pressure for that visit. Systolic blood pressure is associated with cardiovascular complications

    Measured: 12 Months

  8. Change in Diastolic Blood Pressure From Baseline

    Blood pressure is measured by study RAs after the patient is seated for 5 minutes, with the average of three readings used as the diastolic blood pressure for that visit.

    Measured: 6 Months

  9. Change in Diastolic Blood Pressure From 6 Months to 12 Months

    Blood pressure is measured by study RAs after the patient is seated for 5 minutes, with the average of three readings used as the diastolic blood pressure for that visit.

    Measured: 12 Months

  10. Change in Summary of Diabetes Self-care Activities From Baseline

    Summary of Diabetes Self-care Activities (Toobert, Hampson, Glasgow, \& RE, 2000). The Summary consists of 6 subscales representing different domains of diabetes related healthy behaviors and self-care. It has been validated in over 10 studies, with the results published in two manuscripts: one with three studies (Toobert \& Glasgow, 1994), and one with seven studies(Toobert et al., 2000). Each measure ranges from Each range from 0-7, indicating number of days per week patient reports engaging in these behaviors.

    Measured: 6 Months

  11. Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months

    Summary of Diabetes Self-care Activities (Toobert, Hampson, Glasgow, \& RE, 2000). The Summary consists of 6 subscales representing different domains of diabetes related healthy behaviors and self-care. It has been validated in over 10 studies, with the results published in two manuscripts: one with three studies (Toobert \& Glasgow, 1994), and one with seven studies(Toobert et al., 2000). Each measure ranges from Each range from 0-7, indicating number of days per week patient reports engaging in these behaviors.

    Measured: 12 Months

  12. Change in Wilson 3 Item Scale From Baseline

    Medication adherence(Wilson et al.,2014). The 3item medication adherence scale is a self-report measure that assessing no. of days medication missed in prior month, days taken medication as advised \& self-rated medication adherence. Developed in HIV research, it has been validated for non-HIV medications (Wilson, et al,2016). Each component contributes 33% of the scale. Total score ranges from 0-100. It is the combination of 3 sub-scores, (days missed dose(negative scored), self-rating, days taking medications as indicated). Higher scores indicate better medication adherence.

    Measured: 6 Months

  13. Change in Wilson 3 Item Scale From 6 Months to 12 Months

    Medication adherence(Wilson et al.,2014). The 3item medication adherence scale is a self-report measure that assessing no. of days medication missed in prior month, days taken medication as advised \& self-rated medication adherence. Developed in HIV research, it has been validated for non-HIV medications (Wilson, et al,2016). Each component contributes 33% of the scale. Total score ranges from 0-100. It is the combination of 3 sub-scores, (days missed dose(negative scored), self-rating, days taking medications as indicated). Higher scores indicate better medication adherence.

    Measured: 12 Months

  14. Change in Healthcare Utilization From Baseline

    Healthcare utilization by EMR review of clinic appointments, ED visits and hospitalizations within enrollment through 6 months at each follow up visit.

    Measured: 6 Months

  15. Change in Healthcare Utilization From 6 Months to 12 Months

    Healthcare utilization by EMR review of clinic appointments, ED visits and hospitalizations within enrollment through 6 months at each follow up visit.

    Measured: 12 Months

  16. Change in Diabetes Empowerment Scale Short Form From Baseline

    Change in Self-efficacy. Diabetes Empowerment Scale Short Form (Anderson, Fitzgerald, Gruppen, Funnell, \& Oh, 2003), is a measure of a patient's overall diabetes related self-efficacy, shortened by the original from 37 to an 8 item scale. It has reliability of alpha=0.84; and has been shown to be sensitive to change in multiple populations and is correlated with improved glycemic control measured by A1C (Anderson et al., 2003). It ranges from 8-40 points; higher score indicates higher self-efficacy.

    Measured: 6 Months

  17. Change in Diabetes Empowerment Scale Short Form From 6 Months to 12 Months

    Change in Self-efficacy. Diabetes Empowerment Scale Short Form (Anderson, Fitzgerald, Gruppen, Funnell, \& Oh, 2003), is a measure of a patient's overall diabetes related self-efficacy, shortened by the original from 37 to an 8 item scale. It has reliability of alpha=0.84; and has been shown to be sensitive to change in multiple populations and is correlated with improved glycemic control measured by A1C (Anderson et al., 2003). It ranges from 8-40 points; higher score indicates higher self-efficacy.

    Measured: 12 months

  18. Change in Diabetes Distress Scale From Baseline

    Diabetes related distress (Diabetes Distress Scale) (Polonsky et al., 2005), is a 17 item scale measuring distress related to emotional burden, physician-related distress, regimen-related distress, and diabetes-related interpersonal issues. It has a Cronbach's alpha of 0.88-0.93 in various studies. Higher scores are negatively correlated with several healthy behaviors. Each question is a Likert scale ranking of how serious a particular issue is from 1-6, 6 indicating a more significant problem. The scores are then averaged across all item, with final scores ranging from 1-6, with 6 indicating higher levels of distress

    Measured: 6 Months

  19. Change in Diabetes Distress Scale From 6 Months to 12 Months

    Diabetes related distress (Diabetes Distress Scale) (Polonsky et al., 2005), is a 17 item scale measuring distress related to emotional burden, physician-related distress, regimen-related distress, and diabetes-related interpersonal issues. It has a Cronbach's alpha of 0.88-0.93 in various studies. Higher scores are negatively correlated with several healthy behaviors. Each question is a Likert scale ranking of how serious a particular issue is from 1-6, 6 indicating a more significant problem. The scores are then averaged across all item, with final scores ranging from 1-6, with 6 indicating higher levels of distress

    Measured: 12 Months

  20. Change in Patient Health Questionnaire 9 From Baseline

    Depression as measured by the PHQ-9 (Kroenke, Spitzer, Williams, \& Lowe, 2010), is a widely used scale of depression used in clinical practice and research. The Cronbach's alpha ranges from 0.86-0.89, and it has been validated in multiple languages. Depression is worse with higher scores. Score ranges from 0 to 27. Higher levels of depression are associated with fewer healthy behaviors and worse glycemic control.

    Measured: 6 Months

  21. Change in Patient Health Questionnaire 9 From 6 Months to 12 Months

    Depression as measured by the PHQ-9 (Kroenke, Spitzer, Williams, \& Lowe, 2010), is a widely used scale of depression used in clinical practice and research. The Cronbach's alpha ranges from 0.86-0.89, and it has been validated in multiple languages. Depression is worse with higher scores. Score ranges from 0 to 27. Higher levels of depression are associated with fewer healthy behaviors and worse glycemic control.

    Measured: 12 Months

  22. Change in Fatalism From Baseline

    Fatalism is measured by the Diabetes Fatalism Scale (Egede \& Ellis, 2010), which measures three subscale emotional distress, religiosity and coping and perceived self-efficacy, which are summed together. The total score ranges from 12-72, higher score indicates higher fatalism, and has a Cronbach's alpha of 0.80. The score is associated with glycemic control, depression, self-care behaviors and social factors.

    Measured: 6 Months

  23. Change in Fatalism From 6 Months to 12 Months

    Fatalism is measured by the Diabetes Fatalism Scale (Egede \& Ellis, 2010), which measures three subscale emotional distress, religiosity and coping and perceived self-efficacy, which are summed together. The total score ranges from 12-72, higher score indicates higher fatalism, and has a Cronbach's alpha of 0.80. The score is associated with glycemic control, depression, self-care behaviors and social factors.

    Measured: 12 Months

  24. Change in WHO Quality of Life From Baseline

    Quality of life (World Health Organization WHO-5 Well Being Index) (Topp, Ostergaard, Sondergaard, \& Bech, 2015) is a widely used measure of quality life, validated in many languages and consists of only 5 items. Each self-reported item is scored between 0 and 5, summed together and then multiplied by 4. The total range is from 0 to 100, with 0 being the lowest quality of life.

    Measured: 6 Months

  25. Change in WHO Quality of Life From 6 Months to 12 Months

    Quality of life (World Health Organization WHO-5 Well Being Index) (Topp, Ostergaard, Sondergaard, \& Bech, 2015) is a widely used measure of quality life, validated in many languages and consists of only 5 items. Each self-reported item is scored between 0 and 5, summed together and then multiplied by 4. The total range is from 0 to 100, with 0 being the lowest quality of life.

    Measured: 12 Months

  26. Change in Diabetes Family Behavior Checklist - Supportive From Baseline

    Diabetes-related supportive and obstructive family behaviors are measured by patient report on the Diabetes Family Behavior checklist (Lewin et al., 2005). Family behaviors: supportive and non-supportive sub-scores of the Diabetes Family Behavior Checklist: supportive ranges from 4-45 (4 being lowest in family supportive behavior), non-supportive ranges from 7-35 (4 indicating least report of non-supportive behavior). Non-supportive scores are subtracted form supportive scores for a total.

    Measured: 6 Months

  27. Change in Diabetes Family Behavior Checklist Supportive From 6 Months to 12 Months

    Diabetes-related supportive and obstructive family behaviors are measured by patient report on the Diabetes Family Behavior checklist (Lewin et al., 2005). Family behaviors: supportive and non-supportive sub-scores of the Diabetes Family Behavior Checklist: supportive ranges from 4-45 (4 being lowest in family supportive behavior), non-supportive ranges from 7-35 (4 indicating least report of non-supportive behavior). Non-supportive scores are subtracted form supportive scores for a total.

    Measured: 12 Months

  28. Change in Diabetes Family Behavior Checklist - Nonsupportive From Baseline

    Diabetes-related supportive and obstructive family behaviors are measured by patient report on the Diabetes Family Behavior checklist (Lewin et al., 2005). Family behaviors: supportive and non-supportive sub-scores of the Diabetes Family Behavior Checklist: supportive ranges from 4-45 (4 being lowest in family supportive behavior), non-supportive ranges from 7-35 (4 indicating least report of non-supportive behavior). Non-supportive scores are subtracted form supportive scores for a total.

    Measured: 6 Months

  29. Change in Diabetes Family Behavior Checklist Nonsupportive From 6 Months to 12 Months

    Diabetes-related supportive and obstructive family behaviors are measured by patient report on the Diabetes Family Behavior checklist (Lewin et al., 2005). Family behaviors: supportive and non-supportive sub-scores of the Diabetes Family Behavior Checklist: supportive ranges from 4-45 (4 being lowest in family supportive behavior), non-supportive ranges from 7-35 (4 indicating least report of non-supportive behavior). Non-supportive scores are subtracted form supportive scores for a total.

    Measured: 12 Months

  30. Change in Diabetes Care Profile Support From Baseline

    Diabetes-specific social support is measured by the Diabetes Care Profile Support Questions,(Fitzgerald et al., 1996) with sub-scores for perceived disease specific support needs and perceived disease specific support received. Diabetes Care Profile support questions: Support wanted, and support received. Each range from 5 to 30, high scores indicating high desire for support and higher support received.

    Measured: 6 Months

  31. Change in Diabetes Care Profile Support From 6 Months to 12 Months

    Diabetes-specific social support is measured by the Diabetes Care Profile Support Questions,(Fitzgerald et al., 1996) with sub-scores for perceived disease specific support needs and perceived disease specific support received. Diabetes Care Profile support questions: Support wanted, and support received. Each range from 5 to 30, high scores indicating high desire for support and higher support received.

    Measured: 12 Months

  32. Change in Norbeck Social Support Questionnaire From Baseline

    Measure Description: General social support is captured by the Norbeck Social Support Questionnaire Emotional and\&Tangible subscales.(Norbeck, Lindsey, \& Carrieri, 1981) General social support: Norbeck Social Support Questionnaire, emotional sub score (ranges 0-16, with higher scores indicating higher perceived emotional support) \& tangible sub score (0-8, higher score indicating higher perceived tangible support). While the subscores are highly correlated, the authors do not recommend Cronbach's alpha as a test of internal validity.(http://eileengigliotti.com/uploads/1/1/0/2/110241155/nssq-psychometric.pdf)

    Measured: 6 Months

  33. Change in Norbeck Social Support Questionnaire From 6 Months to 12 Months

    Measure Description: General social support is captured by the Norbeck Social Support Questionnaire Emotional and\&Tangible subscales.(Norbeck, Lindsey, \& Carrieri, 1981) General social support: Norbeck Social Support Questionnaire, emotional sub score (ranges 0-16, with higher scores indicating higher perceived emotional support) \& tangible sub score (0-8, higher score indicating higher perceived tangible support). While the subscores are highly correlated, the authors do not recommend Cronbach's alpha as a test of internal validity.(http://eileengigliotti.com/uploads/1/1/0/2/110241155/nssq-psychometric.pdf)

    Measured: 12 Months

  34. Change in Partner Distress Scale From Baseline

    Supporter diabetes-related distress is measured by the Partner Distress Scale (Polonsky, Fisher, Hessler, \&Johnson, 2016). The self-report scale consists of 21 items in 4 domains: "my partner's diabetes management", "how best to help", "diabetes \& me", \& "hypoglycemia". Domains are summed together. Each item is score from 0 to 4, lower scores indicate less distress. The total score is an average of the 21 items. The Cronbach's alpha was 0.76 for total scores. Greater partner distress is correlated with higher A1C among patients, worse self-care \& lower satisfaction with relationship

    Measured: 6 Months

Timeline

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

  1. First posted7 Jun 2017
  2. Study start18 Jul 2017
  3. Primary completion2 Dec 2019
  4. Study completion2 Dec 2019

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 2
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
166 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03178773
Sponsor's protocol ID
HS-17-00406
Acronym
TExTMED+FANSII
Status last verified
Jul 2021
First submitted
5 Jun 2017
Last updated
6 Aug 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Burner E, Hazime D, Menchine M, Mack W, Mercado J, Aleman A, Hernandez Saenz A, Arora S, Wu S. mHealth Social Support Versus Standard Support for Diabetes Management in Safety-Net Emergency Department Patients: Randomized Phase-III Trial. JMIR Diabetes. 2025 Apr 23;10:e56934. doi: 10.2196/56934.

    PubMed 40266665

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TExT-MED and FANS in people with Diabetes, 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 3 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 Aug 2021. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Aug 2021). 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?

Change in HBA1c From Baseline (time frame: 6 Months). 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 NCT03178773, which also lists 1 linked publication.

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 Aug 2021.

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