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| ID | Type | Description | Link |
|---|---|---|---|
| KL2TR000131 | U.S. NIH Grant/Contract | View source |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TExT-MED only | Active Comparator | Patients will receive TExT-MED intervention, but supporters will not receive additional messages |
|
| TExT-MED FANS | Experimental | Patients get TExT-MED intervention, supporter gets FANS curriculum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TExT MED | Behavioral | educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes Knowledge Test Scale | Diabetes Knowledge Test Scale measures specific areas of diabetes knowledge, and is geared to specific curriculum | 3 months after enrollment |
| Change in Self-efficacy |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LAC+USC | Los Angeles | California | 90033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23439166 | Background | 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. | |
| 22524591 | Background | 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. |
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14 patients dropped before randomization
745 patients screened
Excluded:
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| ID | Title | Description |
|---|---|---|
| FG000 | TExT-MED Only | Patients will receive TExT-MED (Trial to Examine Text-Based mHealth for Emergency department patients with Diabetes) intervention, but supporters will not receive additional messages TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone |
| FG001 | TExT-MED FANS | Patients get TExT-MED intervention, supporter gets FANS curriculum (Trial to Examine Text-Based mHealth for Emergency department patients with Diabetes with Family And friends Network Supporters) TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone FANS: supporter curriculum of messages, consisting of educational/motivational messages, and support challenges |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TExT-MED Only | Patients will receive TExT-MED intervention, but supporters will not receive additional messages TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone |
| BG001 | TExT-MED FANS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility | Number of patients lost to follow-up | Posted | Count of Participants | Participants | 3 months after enrollment |
|
3 months
patients reported any adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TExT-MED Only | Patients will receive TExT-MED intervention, but supporters will not receive additional messages TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone |
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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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Burner | University of Southern California | 3232266667 | eburner@usc.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| FANS | Behavioral | supporter curriculum of messages, consisting of educational/motivational messages, and support challenges |
|
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 months after enrollment |
| 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 | 3 months after enrollment |
| Glycemic Control | glycosylated hemoglobin A1c | 3 months after enrollment |
| Body Mass Index | height and weight measurements | 3 months after enrollment |
| 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) | 3 months follow up |
| 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) | 3 months follow up |
| 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) | 3 months follow up |
| 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) | 3 months follow up |
| 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) | 3 months follow up |
| 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) | 3 months follow up |
Patients get TExT-MED intervention, supporter gets FANS curriculum TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone FANS: supporter curriculum of messages, consisting of educational/motivational messages, and support challenges |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Language | Count of Participants | Participants |
|
|
|
| Primary | 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? | Posted | Count of Participants | Participants | 3 months after enrollment |
|
|
|
| Primary | Acceptability 2: Would Patients Recommend the Program to Family or Friends? | Response to: Would you recommend TExT-MED FANS to family or friends? | Posted | Count of Participants | Participants | 3 months follow up |
|
|
|
| Secondary | Diabetes Knowledge Test Scale | Diabetes Knowledge Test Scale measures specific areas of diabetes knowledge, and is geared to specific curriculum | Data was not collected as final program educational curriculum did not have sufficient overlap with Diabetes Knowledge Test Scale | Posted | 3 months after enrollment |
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | 3 months after enrollment |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | 3 months after enrollment |
|
|
|
| Secondary | Glycemic Control | glycosylated hemoglobin A1c | Posted | Mean | 95% Confidence Interval | % glycoslated hemoglobin | 3 months after enrollment |
|
|
|
| Secondary | Body Mass Index | height and weight measurements | Was not able to be collected | Posted | 3 months after enrollment |
|
|
| Secondary | 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) | Posted | Mean | 95% Confidence Interval | units on a scale | 3 months follow up |
|
|
|
| Secondary | 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) | Posted | Mean | 95% Confidence Interval | units on a scale | 3 months follow up |
|
|
|
| Secondary | 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) | Posted | Mean | 95% Confidence Interval | units on a scale | 3 months follow up |
|
|
|
| Secondary | 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) | Posted | Mean | 95% Confidence Interval | units on a scale | 3 months follow up |
|
|
|
| Secondary | 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) | Posted | Mean | 95% Confidence Interval | units on a scale | 3 months follow up |
|
|
|
| Secondary | 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) | Posted | Mean | 95% Confidence Interval | units on a scale | 3 months follow up |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | TExT-MED FANS | Patients get TExT-MED intervention, supporter gets FANS curriculum TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone FANS: supporter curriculum of messages, consisting of educational/motivational messages, and support challenges | 0 | 22 | 0 | 22 | 0 | 22 |
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